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Tag: Pharmaceuticals

  • Trump claims credit for Biden’s insulin price cap

    Trump claims credit for Biden’s insulin price cap

    President Joe Biden and former President Donald Trump 2024.

    Kevin Lamarque | Jay Paul | Reuters

    Former President Donald Trump on Saturday recognized that the price of insulin is lower under President Joe Biden, but he still wants voters to credit his own administration.

    “Low INSULIN PRICING was gotten for millions of Americans by me, and the Trump Administration, not by Crooked Joe Biden. He had NOTHING to do with it,” Trump wrote in a Truth Social post. “It was all done long before he so sadly entered office. All he does is try to take credit for things done by others, in this case, ME!”

    The comment comes as Trump lags Biden on the issue of health care, a top voter priority as the November election nears.

    For example, a May survey from KFF, a nonpartisan health policy research group, found Biden with an 11-point lead over Trump on the question of ensuring access to affordable health insurance.

    Biden led on several other health-care-related topics in the poll, though the candidates were relatively split on addressing high health-care costs. The poll surveyed 1,479 U.S. adults from April 23 to May 1 and the margin of error is +/- 3 percentage points.

    The two candidates are expected to have their first face-to-face presidential debate on June 27.

    Insulin price caps have become a central piece of evidence for Biden’s broader economic argument on the campaign trail against Trump.

    Under the Inflation Reduction Act, Biden issued a host of provisions aimed at bringing down the price of medicine for seniors, including capping the price of insulin at $35 per month for Medicare recipients. The president has continued to push for a more universal insulin cap that would cover younger people as well.

    “Instead of paying $400 a month for insulin, seniors with diabetes only have to pay $35 a month!” Biden said at his State of the Union address in March. “And now I want to cap the cost of insulin at $35 a month for every American who needs it!”

    The Democratic incumbent is trying to use lower insulin costs as proof that he has helped lower consumer costs despite the stubbornly high levels of inflation that have loomed over the U.S. economy’s post-pandemic recovery.

    For Trump’s part, the former president signed an executive order in the last year of his administration to issue his own $35 price cap on insulin. Biden later paused that policy when he took office as part of a larger freeze to allow his administration to review new regulations set to go into effect.

    But the memory of Trump-era health-care policies has still dimmed some voters’ views on the track record of the presumptive GOP presidential nominee. A CNBC All-America Economic survey issued in December found that Biden was ahead by 19 points against Trump on health care.

    Trump unsuccessfully spent most of his presidential term trying to repeal the Obama-era Affordable Care Act without offering a viable alternative health-care option. The ACA provides roughly 45 million Americans wit health insurance, according to a March estimate from the White House.

    Trump has doubled down on the promise to replace Obamacare on the 2024 campaign trail, though he has still not outlined what that replacement would look like.

    “I’m not running to terminate the ACA as Crooked Joe Biden says all over the place,” Trump said in a video posted to his Truth Social account in April. “We’re going to make the ACA much better than it is right now and much less expensive for you.”

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  • Wells Fargo CEO talks up reasons to love the stock — plus, what’s behind the market drop

    Wells Fargo CEO talks up reasons to love the stock — plus, what’s behind the market drop

    Every weekday, the CNBC Investing Club with Jim Cramer releases the Homestretch — an actionable afternoon update, just in time for the last hour of trading on Wall Street.

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  • Judge rejects J&J, Bristol Myers Squibb challenges to Medicare drug-price negotiations

    Judge rejects J&J, Bristol Myers Squibb challenges to Medicare drug-price negotiations

    Jonathan Raa | Nurphoto | Getty Images

    A federal judge in New Jersey on Monday rejected Johnson & Johnson‘s and Bristol Myers Squibb‘s legal challenges to the Biden administration’s Medicare drug-price negotiations, ruling that the program is constitutional. 

    The decision is another win for the White House in a bitter legal fight with several drugmakers over the price talks. The ruling also weakens the pharmaceutical industry’s strategy of seeking split decisions in lower courts scattered across the U.S., which could escalate the issue to the Supreme Court. 

    Medicare drug-price negotiations are a key policy under President Joe Biden’s Inflation Reduction Act that aims to make costly medications more affordable for seniors. In doing so, it could take a bite out of drugmakers’ profits. Final negotiated prices for the first round of drugs subject to the talks, which includes one each from J&J and Bristol Myers, will go into effect in 2026. 

    J&J and Bristol Myers Squibb did not immediately respond to requests for comment on the ruling. 

    In separate lawsuits, the drugmakers argued that the negotiations are an unconstitutional confiscation of their drugs by the government and a violation of their right to freedom of speech. They also argued that the talks are an unconstitutional condition to participate in the Medicaid and Medicare programs.

    But Judge Zahid Quraishi of the District of New Jersey wrote in a 26-page opinion that participation in the price talks and Medicare and Medicaid markets is voluntary.

    The negotiations don’t require drugmakers to “set aside, keep or otherwise reserve any of their drugs” for the use of the government or Medicare beneficiaries, he wrote. Quraishi added the talks don’t force manufacturers to physically transmit or transport drugs at a new negotiated price.

    “Selling to Medicare may be less profitable than it was before the institution of the Program, but that does not make [J&J and Bristol Myers Squibb’s] decision to participate any less voluntary,” Quraishi wrote. “For the reasons provided, the Court concludes that the Program does not result in a physical taking nor direct appropriation” of medications from the two drugmakers. 

    J&J, Bristol Myers Squibb, Novo Nordisk and Novartis presented their oral arguments before Quraishi during the same hearing in March.

    That same month, a federal judge in Delaware rejected AstraZeneca’s separate lawsuit challenging the negotiations. In Texas, a third federal judge tossed a separate lawsuit in February.

    A federal judge in Ohio also issued a ruling in September denying a preliminary injunction sought by the Chamber of Commerce, one of the largest lobbying groups in the country, which aimed to block the price talks before Oct. 1.

    Don’t miss these exclusives from CNBC PRO

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  • Price.com Partners With Cuban’s Cost Plus Drug – Los Angeles Business Journal

    Price.com Partners With Cuban’s Cost Plus Drug – Los Angeles Business Journal

    Price.com Partners With Cuban’s Cost Plus Drug

    Beverly Hills-based Price.com is partnering with Mark Cuban’s Marc Cuban Cost Plus Drug Company to help consumers save money on prescription drugs and make the buying process easier.

    Price.com offers price comparisons for everything from travel to fashion. The company takes a cut on the transactions done through its site.

    Price.com, which currently has 30 employees, is in growth mode, and said it is looking to expand overseas and grow to closer to 100 employees in the next few years.

    In addition to Cuban’s Cost Plus Drug Company, Price.com also partners with other businesses. RJ Jain, the founder of Price.com, said the latest partnership was based on a “shared mission and values.”

    RJ Jain, CEO of Price.com.

    Under the partnership, Cost Plus Drug medications will show up on Price.com’s interface, which will “bring more customers to them,” Jain said.

    “We show on our website their data. If you search for a medicine, in the price comparison we show them and the other options as well, so people can see all of their buying options in one place,” he said.

    “We are thrilled to collaborate with Price.com in our mission to make prescription drugs more affordable for consumers,” Alex Oshmyansky, chief executive of Cost Plus Drug, said in a statement. “Our commitment to transparent drug pricing has always been unwavering, and with Price.com, we are dedicated to providing affordable and accessible health care solutions for all.”

    James Brock

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  • How a medication abortion, also known as an ‘abortion pill,’ works | CNN

    How a medication abortion, also known as an ‘abortion pill,’ works | CNN



    CNN
     — 

    While the fate of mifepristone, one of two drugs used for medication abortions, is in the hands of the US Supreme Court, the drug continues to be available in states where abortion is legal.

    “While many women obtain medication abortion from a clinic or their OB-GYN, others obtain the pills on their own to self-induce or self-manage their abortion,” said Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.

    “A growing body of research indicates that self-managed abortion is safe and effective,” he said.

    Mifepristone blocks the hormone progesterone, which is needed for a pregnancy to continue. The drug is approved to end a pregnancy through 10 weeks’ gestation, which is “70 days or less since the first day of the last menstrual period,” according to the FDA.

    In a medication abortion, a second drug, misoprostol, is taken within the next 24 to 48 hours. Misoprostol causes the uterus to contract, creating cramping and bleeding. Approved for use in other conditions, such as preventing stomach ulcers, the drug has been available at pharmacies for decades.

    Together, the two drugs are commonly known as the “abortion pill,” which is now used in more than half of the abortions in the United States, according to the Guttmacher Institute, a research group that supports abortion rights.

    “Some people do this because they cannot access a clinic — particularly in states with legal restrictions on abortion — or because they have a preference for self-care,” said Grossman, who is also the director of Advancing New Standards in Reproductive Health, a research group that evaluates the pros and cons of reproductive health policies and publishes studies on how abortion affects a woman’s health.

    READ MORE: With US Supreme Court abortion drug hearing looming, study shows how self-managed abortion became more common post-Dobbs

    What happens during a medication abortion? To find out, CNN spoke with Grossman. This conversation has been condensed and edited for clarity.

    CNN: What is the difference between a first-trimester medication abortion and a vacuum aspiration in terms of what a woman experiences?

    Dr. Daniel Grossman: A vacuum aspiration is most commonly performed under a combination of local anesthetic and oral pain medications or local anesthetic together with intravenous sedation, or what is called conscious sedation.

    An injection of local anesthetic is given to the area around the cervix, and the cervix is gently dilated or opened up. Once the cervix is opened, a small straw-like tube is inserted into the uterus, and a gentle vacuum is used to remove the pregnancy tissue. Contrary to what some say, if the procedure is done before nine weeks or so, there’s nothing in the tissue that would be recognizable as a part of an embryo.

    The aspiration procedure takes just a couple of minutes. Then the person is observed for one to two hours until any sedation has worn off. We also monitor each patient for very rare complications, such as heavy bleeding.

    A medication abortion is a more prolonged process. After taking the pills, bleeding and cramping can occur over a period of days. Bleeding is typically heaviest when the actual pregnancy is expelled, but that bleeding usually eases within a few hours. On average people continue to have some mild bleeding for about two weeks or so, which is a bit longer than after a vacuum aspiration.

    Nausea, vomiting, fever, chills, diarrhea and headache can occur after using the abortion pill, and everyone who has a successful medication abortion usually reports some pain.

    In fact, the pain of medication abortion can be quite intense. In the studies that have looked at it, the average maximum level of pain that people report is about a seven to eight out of 10, with 10 being the highest. However, people also say that the pain can be brief, peaking just as the pregnancy is being expelled.

    The level of cramping and pain can depend on the length of the pregnancy as well as whether or not someone has given birth before. For example, a medical abortion at six weeks or less gestation typically has less pain and cramping than one performed at nine weeks. People who have given birth generally have less pain.

    CNN: What can be done to help with the pain of a medication abortion?

    Grossman: There are definitely things that can be used to help with the pain. Research has shown that ibuprofen is better than acetaminophen for treating the pain of medication abortion. We typically advise people to take 600 milligrams every six hours or so as needed.

    Some people take tramadol, a narcotic analgesic, or Vicodin, which is a combination of acetaminophen and hydrocodone. Recent research I was involved in found medications like tramadol can be helpful if taken prophylactically before the pain starts.

    Another successful regimen that we studied combined ibuprofen with a nausea medicine called metoclopramide that also helped with pain. Other than ibuprofen, these medications require a prescription.

    Another study found that a TENS device, which stands for transcutaneous electrical nerve stimulator, helps with the pain of medication abortion. It works through pads put on the abdomen that stimulate the nerves through mild electrical shocks, thus interfering with the pain signals. That’s something people could get without a prescription.

    Pain can be an overlooked issue with medication abortion because, quite honestly, as clinicians, we’re not there with patients when they are in their homes going through this. But as we’ve been doing more research on people’s experiences with medication abortion, it’s become quite clear that pain control is really important. I think we need to do a better job of treating the pain and making these options available to patients.

    CNN: Are there health conditions that make the use of a medication abortion unwise?

    Grossman: Undergoing a medication abortion can be dangerous if the pregnancy is ectopic, meaning the embryo is developing outside of the uterus. It’s rare, happening in about two out of every 100 pregnancies — and it appears to be even rarer among people seeking medication abortion.

    People who have undergone previous pelvic, fallopian tube or abdominal surgery are at higher risk of an ectopic pregnancy, as are those with a history of pelvic inflammatory disease. Certain sexually transmitted infections can raise risk, as does smoking, a history of infertility and use of infertility treatments such as in vitro fertilization (IVF).

    If a person is on anticoagulant or blood thinning drugs or has a bleeding disorder, a medication abortion is not advised. The long-term use of steroids is another contraindication for using the abortion pill.

    Anyone using an intrauterine device, or IUD, must have it removed before taking mifepristone because it may be partially expelled during the process, which can be painful.

    People with chronic adrenal failure or who have inherited a rare disorder called porphyria are not good candidates.

    CNN: Are there any signs of trouble a woman should watch for after undergoing a medication abortion?

    Grossman: It can be common to have a low-grade fever in the first few hours after taking misoprostol, the second drug in a medication abortion. If someone has a low-grade fever — 100.4 degrees to 101 degrees Fahrenheit — that lasts more than four hours, or has a high fever of over 101 degrees Fahrenheit after taking the medications, they do need to be evaluated by a health care provider.

    Heavy bleeding, which would be soaking two or more thick full-size pads an hour for two consecutive hours, or a foul-smelling vaginal discharge should be evaluated as well.

    One of the warning signs of an ectopic pregnancy is severe pelvic pain, particularly on one side of the abdomen. The pain can also radiate to the back. Another sign is getting dizzy or fainting, which could indicate internal bleeding. These are all very rare complications, but it’s wise to be on the lookout.

    We usually recommend that someone having a medication abortion have someone with them during the first 24 hours after taking misoprostol or until the pregnancy has passed. Many people specifically choose to have a medication abortion because they can be surrounded by a partner, family or friends.

    Most people know that the abortion is complete because they stop feeling pregnant, and symptoms such as nausea and breast tenderness disappear, usually within a week of passing the pregnancy. A home urine pregnancy test may remain positive even four to five weeks after a successful medication abortion, just because it takes that long for the pregnancy hormone to disappear from the bloodstream.

    If someone still feels pregnant, isn’t sure if the pregnancy fully passed or has a positive pregnancy test five weeks after taking mifepristone, they need to be evaluated by a clinician.

    People should know that they can ovulate as soon as two weeks after a medication abortion. Most birth control options can be started immediately after a medication abortion.

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  • MD Anderson and C-Biomex sign collaborative research agreement to co-develop CBT-001 radioligand therapy

    MD Anderson and C-Biomex sign collaborative research agreement to co-develop CBT-001 radioligand therapy


    Newswise — HOUSTON & POHANG, South Korea – The University of Texas MD Anderson Cancer Center and C-Biomex Ltd. today announced a strategic research collaboration agreement to co-develop CBT-001, a radioligand targeting the CA9 cancer biomarker. 

    This collaboration brings together MD Anderson’s expertise in translational radiopharmaceutical research with C-Biomex’s differentiated radioligand. The principal investigator for this project is H. Charles Manning, Ph.D., professor of Cancer Systems Imaging and director of the Cyclotron Radiochemistry Facility at MD Anderson. Under the agreement, MD Anderson and C-Biomex plan to conduct preclinical studies of CBT-001 to evaluate its potential for translation into early-phase clinical studies and to support an anticipated Investigational New Drug (IND) application with the Food and Drug Administration (FDA). 

    “With our global expertise in the design and discovery of differentiated peptide-ligands, Dr. Manning and the team at MD Anderson provide a perfect complement to advance the preclinical and clinical development of CBT-001,” said Cha JunHoe, Ph.D., chief executive officer of C-Biomex. “We hope this collaborative research allows us to move swiftly toward an FDA IND application and, ultimately, to an approved treatment that can benefit patients with a variety of cancers.”

    CBT-001 is a radiolabeled isotope (Lutetium-177) attached to a proprietary peptide-ligand targeting CA9 (carbonic anhydrase 9), a biomarker overexpressed in various cancers, including renal, breast and lung cancers. CBT-001’s differentiated early-stage data, generated by C-Biomex in collaboration with the Korea Institute of Radiological and Medical Sciences, represents a strong foundation for this collaborative research.

    The key to success with this type of molecule is specific delivery to the tumor and rapid clearance, with minimal accumulation in healthy cells. Through this research, the collaborators will evaluate systemic and tumor-specific uptake of CBT-001 as well as antitumor efficacy and toxicology in preclinical models.

    C-Biomex, leveraging its unique CUSTM peptide discovery platform technology, is developing CBT-001 and several next-generation radioligand therapies with optimal characteristics. The collaborators anticipate this research will help to inform future preclinical and early-stage clinical investigations of these next-generation therapies.

    “We are pleased to align our broadly engaged theranostics research team at MD Anderson with our colleagues at C-Biomex to advance the development of CBT-001,” Manning said. “We have seen encouraging early data with this radioligand, and we look forward to collaborative work as we seek to bring impactful new treatment options to our patients in need.”

    Under the terms of the agreement, C-Biomex will provide research support funding, and MD Anderson is eligible to receive certain royalties and payments based on a range of future development milestones.

    Read this press release in the MD Anderson Newsroom.

    -30-

    About C-Biomex

    C-Biomex, a private preclinical-stage biopharmaceutical company founded in 2017, is focused on developing innovative radioligand therapies with its proprietary platform technology, CUSTM (Chemistry-based Ultra-Sensitive peptide discovery). C-Biomex’s peptides have demonstrated exceptional tumor binding and selectivity with fast clearance through the renal system. The company is innovating peptides to bring better radioligand therapies to patients with cancer.

    About MD Anderson

    The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world’s most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world, and, in 1971, it became one of the nation’s first National Cancer Institute (NCI)-designated comprehensive cancer centers. MD Anderson is No. 1 for cancer in U.S. News & World Report’s “Best Hospitals” rankings and has been named one of the nation’s top two hospitals for cancer since the rankings began in 1990. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).





    University of Texas MD Anderson Cancer Center

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  • GSK PLC 4Q Pre-items, Pretax Pft GBP1.56B

    GSK PLC 4Q Pre-items, Pretax Pft GBP1.56B


    Corrections & Amplifications

    This headline was corrected at 0731 GMT to reflect GSK PLC 4Q Pre-Items, Pre-Tax Pft GBP1.56B, not GBP8.11B

    Corrections & Amplifications

    This headline was corrected at 0729 GMT to reflect GSK PLC 4Q Adj EPS 28.9p, not Adj EPS GBP1.551

    By Joe Hoppe

    GSK said its sales rose, driven by growth in its best-selling shingles vaccine Shingrix and the launch of RSV vaccine Arexvy earlier last year, and raised its guidance for 2024.

    The British pharmaceutical major posted sales of 8.05 billion pounds ($10.22 billion) for the fourth quarter of 2023, up from GBP7.33 billion the year prior and beating a Visible Alpha consensus of GBP7.61 billion.

    Write to Joe Hoppe at joseph.hoppe@wsj.com



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  • Roche's Cancer Injection Tecentriq SC Gets European Commission Approval

    Roche's Cancer Injection Tecentriq SC Gets European Commission Approval

    By Andrea Figueras

    Roche said that the European Commission approved Tecentriq SC, a cancer immunotherapy subcutaneous injection for multiple cancer types.

    The Swiss pharmaceutical company said Tuesday that it has been granted marketing authorisation for Tecentriq SC, which reduces treatment time by approximately 80% compared with standard IV infusion.

    The subcutaneous injections take between four and eight minutes, while until now the treatment had been given directly into patients’ veins by IV infusion, which takes approximately 30-60 minutes.

    Last year, more than 38,000 people in the EU received Tecentriq to treat different types of lung, liver, bladder and breast cancer, Roche said.

    The company is also working closely with several providers in Europe to include Tecentriq SC in cancer homecare initiatives where possible.

    The injections can also be administered by a healthcare professional outside of the hospital, in a community care setting or at a patient’s home, depending on national regulations and health systems.

    Write to Andrea Figueras at andrea.figueras@wsj.com

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  • Molecular Diagnostics Research That Could Transform Healthcare Featured in the January Issue of ADLM’s The Journal of Applied Laboratory Medicine

    Molecular Diagnostics Research That Could Transform Healthcare Featured in the January Issue of ADLM’s The Journal of Applied Laboratory Medicine

    Newswise — WASHINGTON – Molecular diagnostics is a powerful branch of laboratory medicine that examines the fundamental genetic and biochemical components of life to provide invaluable insights into health and disease. This special issue of the Association for Diagnostics & Laboratory Medicine’s (formerly AACC’s) The Journal of Applied Laboratory Medicine highlights the latest research in this field that could advance care for conditions ranging from infectious diseases to inherited disorders. 

    View the full issue here: https://academic.oup.com/jalm/issue/9/1

    While laboratory medicine experts have used molecular diagnostic methods for years to diagnose and monitor disease, this field continues to evolve rapidly, and has become more relevant than ever in the face of modern healthcare challenges. The COVID-19 pandemic is the most striking recent example of the central role of molecular diagnostics in global health. PCR tests are a type of molecular diagnostic test and, as is well known, have been crucial to controlling the spread of SARS-CoV-2. And pandemic management isn’t the only area of infectious disease testing that molecular diagnostic technology is revolutionizing. Sequencing cell-free DNA in blood samples has the potential to improve infectious disease evaluation and treatment, and is explored in a study published in this special issue.

    Broadening access to personalized medicine is another goal of modern healthcare that wouldn’t be possible without molecular diagnostics. The ability of molecular diagnostics to help tailor treatment to each patient’s unique biological makeup is most evident in the field of pharmacogenomics. Lab experts use molecular diagnostic methods to identify genetic markers that affect drug metabolism and efficacy—information that providers then use in turn to prescribe medication that has the highest likelihood of benefiting patients. Technologies such as next-generation sequencing (NGS) have the potential to increase the availability of pharmacogenomic information, and a review in this special issue of The Journal of Applied Laboratory Medicine discusses how clinical laboratories can implement NGS for this purpose.

    One other compelling use for molecular diagnostics that is showcased in this special issue is genomic population screening, which has the potential to shift the healthcare paradigm from reactive to proactive. In many countries, programs are already being piloted at population scale that detect genetic diseases prior to symptom onset, thereby enabling preventive treatment. A review article in this special issue examines important practical considerations that must be taken into account as such programs expand, such as their economic benefit and the development of policies to guide them.

    “In the grand tapestry of modern healthcare and precision medicine, molecular diagnostics stands as a vibrant thread, woven with the promise of better patient outcomes, cost savings, and a deeper understanding of the molecular underpinnings of health and disease,” wrote issue editors and molecular diagnostic experts Drs. Nikoletta Sidiropoulos, Eric Vail, Erin H. Graf, Ann M. Moyer, Jillian G. Buchan, and Valentina Nardi in the preamble to the special issue. “It is our hope that the content of this issue will conjure professional reflection and spark collegial discussion in the community to embrace current practices and address and overcome current and future challenges so that the field may continue to improve human health and well-being.”

     

    About the Association for Diagnostics & Laboratory Medicine (ADLM)

    Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.

    The Journal of Applied Laboratory Medicine (academic.oup.com/jalm) is published online by ADLM. This international, peer-reviewed publication showcases applied research on clinically relevant laboratory topics as well as commentary on the practice of clinical chemistry and laboratory medicine. 

    Association for Diagnostic and Laboratory Medicine (ADLM (formerly AACC))

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  • The Russell 2000 Index has soared, but you might be better off looking elsewhere for quality small-cap stocks

    The Russell 2000 Index has soared, but you might be better off looking elsewhere for quality small-cap stocks

    The Russell 2000 Index soared 12% in December, which might reflect investors’ exuberance about the state of the U.S. economy — it appears the Federal Reserve has won its battle against inflation.

    But if you are looking to broaden your exposure to the stock market beyond the large-cap S&P 500
    SPX,
    buying shares of a fund that tracks the Russell 2000 Index
    RUT
    might not be the best way to do it. This is because the Russell 2000 isn’t selective — it is made up of the smallest 2,000 companies by market capitalization in the Russell 3000 Index
    RUA,
    which itself is designed to capture about 98% of the U.S. public equity market.

    A better choice might be the S&P Small Cap 600 Index
    SML
    because S&P Global requires companies to show four consecutive quarters of profitability to be initially included in the index, among other criteria.

    Below is a screen of analysts’ favorite stocks among the S&P Small Cap 600, along with another for the Russell 2000.

    Watch for a “head fake”

    Much of the small-cap buying in December might have resulted from covering of short positions by hedge-fund managers. This idea is backed by the timing of trading activity immediately following the Federal Open Market Committee’s announcement on Dec. 13 that it wouldn’t change its interest-rate policy, according to MacroTourist blogger Kevin Muir. The Fed’s economic projections released the same day also indicate three cuts to the federal-funds rate in 2024.

    Heading into the end of the year, a fund manager who had shorted small-caps, and then was surprised by the Fed’s interest-rate projections, might have scrambled to buy stocks it had shorted to close-out the positions and hopefully lock in gains, or limit losses.

    That buying activity and resulting pop in small-cap prices could set up a typical “head fake” for investors as the new year begins, according to Muir.

    The long-term case for quality

    Looking at data for companies’ most recently reported fiscal quarters, 58% of the Russell 2000 reported positive earnings per share, according to data provided by FactSet. In other words, hundreds of these companies were losing money. These might include promising companies facing “binary events,” such as make-or-break drug trials in the biotechnology industry.

    In comparison, 78% of companies among the S&P Small Cap 600 were profitable, and 93% of the S&P 500 were in the black.

    Here are long-term performance figures for exchange-traded funds that track all three indexes:

    ETF

    Ticker

    2023

    3 years

    5 years

    10 years

    15 years

    20 years

    iShares Russell 2000 ETF

    IWM 17%

    7%

    61%

    99%

    428%

    365%

    iShares Core S&P Small Cap ETF

    IJR 16%

    25%

    69%

    129%

    540%

    515%

    SPDR S&P 500 ETF Trust

    SPY 26%

    34%

    108%

    210%

    629%

    527%

    Source: FactSet

    An approach tracking the S&P Small Cap 600 has outperformed the Russell 2000 for all periods, with margins widening as you go further back.

    Brett Arends: You own the wrong small-cap fund. How to get into a better one.

    Looking ahead for quality… or not

    For the first screen, we began with the S&P Small Cap 600 and narrowed the list to 385 companies covered by at least five analysts polled by FactSet. Then we cut the list to 92 companies with “buy” or equivalent ratings among at least 75% of the covering analysts.

    Here are the 20 remaining stocks among the S&P Small Cap 600 with the highest 12-month upside potential indicated by analysts’ consensus price targets:

    Company

    Ticker

    Share “buy” ratings

    Dec. 29 price

    Consensus price target

    Implied 12-month upside potential

    Vir Biotechnology Inc.

    VIR,
    +4.47%
    88%

    $10.06

    $32.00

    218%

    Arcus Biosciences Inc.

    RCUS,
    +3.04%
    82%

    $19.10

    $41.00

    115%

    Xencor Inc.

    XNCR,
    +6.03%
    92%

    $21.23

    $39.83

    88%

    Dynavax Technologies Corp.

    DVAX,
    +2.86%
    100%

    $13.98

    $24.80

    77%

    ModivCare Inc.

    MODV,
    +0.95%
    100%

    $43.99

    $75.50

    72%

    Xperi Inc

    XPER,
    +1.81%
    80%

    $11.02

    $18.20

    65%

    Thryv Holdings Inc.

    THRY,
    100%

    $20.35

    $32.75

    61%

    Ligand Pharmaceuticals Inc.

    LGND,
    +1.25%
    100%

    $71.42

    $114.80

    61%

    Green Plains Inc.

    GPRE,
    -1.67%
    80%

    $25.22

    $40.30

    60%

    Patterson-UTI Energy Inc.

    PTEN,
    +0.28%
    75%

    $10.80

    $17.00

    57%

    Ironwood Pharmaceuticals Inc. Class A

    IRWD,
    +8.48%
    83%

    $11.44

    $17.83

    56%

    Catalyst Pharmaceuticals Inc.

    CPRX,
    +1.78%
    100%

    $16.81

    $26.20

    56%

    Payoneer Global Inc.

    PAYO,
    -3.45%
    100%

    $5.21

    $8.00

    54%

    Helix Energy Solutions Group Inc.

    HLX,
    -2.63%
    83%

    $10.28

    $15.00

    46%

    Arlo Technologies Inc.

    ARLO,
    -3.05%
    100%

    $9.52

    $13.80

    45%

    Pacira Biosciences Inc.

    PCRX,
    -5.16%
    100%

    $33.74

    $48.40

    43%

    Privia Health Group Inc.

    PRVA,
    +2.95%
    100%

    $23.03

    $32.53

    41%

    Semtech Corp.

    SMTC,
    -1.23%
    92%

    $21.91

    $30.90

    41%

    Talos Energy Inc.

    TALO,
    +1.19%
    78%

    $14.23

    $20.00

    41%

    Digi International Inc.

    DGII,
    -1.21%
    100%

    $26.00

    $36.14

    39%

    Source: FactSet

    Any stock screen should only be considered a starting point. You should do your own research to form your own opinion before making any investment. one way to begin is by clicking on the tickers for more about each company.

    Click here for Tomi Kilgore’s detailed guide to the wealth of information available for free on the MarketWatch quote page.

    Moving on to the Russell 2000, when we narrowed this group to stocks covered by at least five analysts polled by FactSet, we were left with 936 companies. Among these, 355 have “buy” or equivalent ratings among at least 75% of the covering analysts.

    Among those 355 stocks in the Russell 2000, these 20 have the highest implied upside over the next year, based on consensus price targets:

    Company

    Ticker

    Share “buy” ratings

    Dec. 29 price

    Consensus price target

    Implied 12-month upside potential

    Karyopharm Therapeutics Inc.

    KPTI,
    +4.18%
    75%

    $0.87

    $6.00

    594%

    Rallybio Corp.

    RLYB,
    +0.42%
    100%

    $2.39

    $16.50

    590%

    Vor Biopharma Inc.

    VOR,
    -0.89%
    100%

    $2.25

    $15.44

    586%

    Tenaya Therapeutics Inc.

    TNYA,
    -0.62%
    100%

    $3.24

    $19.14

    491%

    Compass Therapeutics Inc.

    CMPX,
    -5.13%
    86%

    $1.56

    $9.17

    488%

    Vigil Neuroscience Inc.

    VIGL,
    +2.66%
    88%

    $3.38

    $18.75

    455%

    Trevi Therapeutics Inc.

    TRVI,
    -2.99%
    100%

    $1.34

    $7.33

    447%

    Inozyme Pharma Inc.

    INZY,
    +1.64%
    100%

    $4.26

    $21.00

    393%

    Gritstone bio Inc.

    GRTS,
    +6.86%
    100%

    $2.04

    $10.00

    390%

    Actinium Pharmaceuticals Inc.

    ATNM,
    +4.72%
    83%

    $5.08

    $23.36

    360%

    Lineage Cell Therapeutics Inc.

    LCTX,
    86%

    $1.09

    $4.83

    343%

    Century Therapeutics Inc.

    IPSC,
    +9.64%
    86%

    $3.32

    $14.67

    342%

    Acrivon Therapeutics Inc.

    ACRV,
    +1.83%
    100%

    $4.92

    $21.13

    329%

    Avidity Biosciences Inc.

    RNA,
    +1.22%
    100%

    $9.05

    $37.50

    314%

    Longboard Pharmaceuticals Inc.

    LBPH,
    +316.25%
    100%

    $6.03

    $24.17

    301%

    Omega Therapeutics Inc.

    OMGA,
    -1.33%
    100%

    $3.01

    $12.00

    299%

    Allogene Therapeutics Inc.

    ALLO,
    +12.77%
    82%

    $3.21

    $12.79

    298%

    X4 Pharmaceuticals Inc.

    XFOR,
    +5.21%
    86%

    $0.84

    $3.26

    289%

    Caribou Biosciences Inc.

    CRBU,
    -2.79%
    89%

    $5.73

    $22.25

    288%

    Stoke Therapeutics Inc.

    STOK,
    +11.41%
    78%

    $5.26

    $19.33

    268%

    Source: FactSet

    That’s right — this Russell 2000 list is all biotech. And in case you are wondering if any companies are on both lists, the answer is no.

    Don’t miss: 11 dividend stocks with high yields expected to be well supported in 2024 per strict criteria

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  • These 20 stocks soared the most in 2023

    These 20 stocks soared the most in 2023

    (Updated with Friday’s closing prices.)

    The 2023 rally for stocks in the U.S. accelerated as more investors bought the idea that the Federal Reserve succeeded in its effort to bring inflation to heel.

    The S&P 500
    SPX
    ended Friday with a 24.2% gain for 2023, following a 19.4% decline in 2022. (All price changes in this article exclude dividends). Among the 500 stocks, 65% were up for 2023. Below is a list of the year’s 20 best performers in the benchmark index.

    This article focuses on large-cap stocks. MarketWatch Editor in Chief Mark DeCambre took a broader look at all U.S. stocks of companies with market capitalizations of at least $1 billion, to list 10 with gains ranging from 412% to 1,924%.

    The Fed began raising short-term interest rates and pushing long-term rates higher in March 2022 by allowing its bond portfolio to run off. That explains the poor performance for stocks in 2022, as bonds and even bank accounts because more attractive to investors.

    The central bank hasn’t raised the federal-funds rate since moving it to the current target range of 5.25% to 5.50% in July, and its economic projections point to three rate cuts in 2024.

    Investors are anticipating the return to a low-rate environment by scooping up 10-year U.S. Treasury notes
    BX:TMUBMUSD10Y,
    whose yield ended the year at 3.88%, down from 4.84% on Oct. 27 — the day of the S&P 500’s low for the second half of 2023.

    Read: Treasury yields end mostly higher but little changed on year after wild 2023

    Before looking at the list of best-performing stocks of 2023, here’s a summary of how the 11 sectors of the S&P 500 performed, with the full index and three more broad indexes at the bottom:

    Sector or index

    2023 price change

    2022 price change

    Price change since end of 2021

    Forward P/E

    Forward P/E at end of 2022

    Forward P/E at end of 2023

    Information Technology

    56.4%

    -28.9%

    11.5%

    26.7

    20.0

    28.2

    Communication Services

    54.4%

    -40.4%

    -7.6%

    17.4

    14.3

    21.0

    Consumer Discretionary

    41.0%

    -37.6%

    -11.4%

    26.2

    21.7

    34.7

    Industrials

    16.0%

    -7.1%

    8.0%

    20.0

    18.7

    22.0

    Materials

    10.2%

    -14.1%

    -4.9%

    19.5

    15.8

    16.6

    Financials

    9.9%

    -12.4%

    -3.4%

    14.6

    13.0

    16.3

    Real Estate

    8.3%

    -28.4%

    -21.6%

    18.3

    16.9

    24.7

    Healthcare

    0.3%

    -3.6%

    -3.3%

    18.2

    17.7

    17.3

    Consumer Staples

    -2.2%

    -3.2%

    -5.4%

    19.3

    20.6

    21.4

    Energy

    -4.8%

    59.0%

    51.8%

    10.9

    9.8

    11.1

    Utilities

    -10.2%

    -1.4%

    -11.4%

    15.9

    18.7

    20.4

    S&P 500
    SPX
    24.2%

    -19.4%

    0.4%

    19.7

    16.8

    21.6

    Dow Jones Industrial Average
    DJIA
    13.7%

    -8.8%

    3.8%

    17.6

    16.6

    18.9

    Nasdaq Composite
    COMP
    43.4%

    -33.1%

    -3.5%

    26.9

    22.6

    32.0

    Nasdaq-100
    NDX
    53.8%

    -33.0%

    3.5%

    26.3

    20.9

    30.3

    Source: FactSet

    A look at 2023 price action really needs to encompass what took place in 2022 for context. The broad indexes haven’t moved much from their levels at the end of 2022 (again, excluding dividends). We have included current forward price-to-earnings ratios along with those at the end of 2021 and 2022. These valuations have declined a bit, which may provide some comfort for investors wondering how likely it is for stocks to continue to rally in 2024.

    Biggest price increases among the S&P 500

    Here are the 20 stocks in the S&P 500 whose prices rose the most in 2023:

    Company

    Ticker

    2023 price change

    2022 price change

    Price change since end of 2021

    Forward P/E

    Forward P/E at end of 2022

    Forward P/E at end of 2021

    Nvidia Corp.

    NVDA,
    239%

    -50%

    68%

    24.9

    34.4

    58.0

    Meta Platforms Inc. Class A

    META,
    -1.22%
    194%

    -64%

    5%

    20.2

    14.7

    23.5

    Royal Caribbean Group

    RCL,
    -0.37%
    162%

    -36%

    68%

    14.3

    14.9

    232.4

    Builders FirstSource Inc.

    BLDR,
    -1.02%
    157%

    -24%

    95%

    14.2

    10.7

    13.3

    Uber Technologies Inc.

    UBER,
    -2.49%
    149%

    -41%

    47%

    56.9

    N/A

    N/A

    Carnival Corp.

    CCL,
    -0.70%
    130%

    -60%

    -8%

    18.7

    41.3

    N/A

    Advanced Micro Devices Inc.

    AMD,
    -0.91%
    128%

    -55%

    2%

    39.7

    17.7

    43.1

    PulteGroup Inc.

    PHM,
    -0.26%
    127%

    -20%

    81%

    9.1

    6.3

    6.2

    Palo Alto Networks Inc.

    PANW,
    -0.24%
    111%

    -25%

    59%

    50.2

    38.0

    70.1

    Tesla Inc.

    TSLA,
    -1.86%
    102%

    -65%

    -29%

    66.2

    22.3

    120.3

    Broadcom Inc.

    AVGO,
    -0.55%
    100%

    -16%

    68%

    23.2

    13.6

    19.8

    Salesforce Inc.

    CRM,
    -0.92%
    98%

    -48%

    4%

    28.0

    23.8

    53.5

    Fair Isaac Corp.

    FICO,
    -0.46%
    94%

    38%

    168%

    47.1

    29.3

    28.7

    Arista Networks Inc.

    ANET,
    -0.62%
    94%

    -16%

    64%

    32.7

    22.3

    41.4

    Intel Corp.

    INTC,
    -0.28%
    90%

    -49%

    -2%

    26.6

    14.6

    13.9

    Jabil Inc.

    JBL,
    -0.45%
    87%

    -3%

    81%

    13.5

    7.9

    10.3

    Lam Research Corp.

    LRCX,
    -0.81%
    86%

    -42%

    9%

    25.2

    13.5

    20.2

    ServiceNow Inc.

    NOW,
    +0.57%
    82%

    -40%

    9%

    56.0

    42.6

    90.1

    Amazon.com Inc.

    AMZN,
    -0.94%
    81%

    -50%

    -9%

    42.0

    46.7

    64.9

    Monolithic Power Systems Inc.

    MPWR,
    -0.23%
    78%

    -28%

    28%

    49.1

    27.3

    57.9

    Source: FactSet

    Click on the tickers for more about each company.

    Click here for Tomi Kilgore’s detailed guide to the wealth of information available for free on the MarketWatch quote page.

    Don’t miss: Nvidia tops list of Wall Street’s 20 favorite stocks for 2024

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  • Intel, Tesla, Apple, Iovance, NetEase, Coherus BioSciences, and More Stock Market Movers

    Intel, Tesla, Apple, Iovance, NetEase, Coherus BioSciences, and More Stock Market Movers

    Stock futures traded slightly lower Wednesday after the S&P 500 finished higher Tuesday and just 0.45% below its record close of 4,796.56 hit Jan. 3, 2022. The broad market index has risen 24% this year and has gained 4.5% this month as traders bet the Federal Reserve will begin cutting interest rates as soon as March.

    Continue reading this article with a Barron’s subscription.

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  • Bristol Myers to Acquire RayzeBio in Deal Valued at $4.1 Billion

    Bristol Myers to Acquire RayzeBio in Deal Valued at $4.1 Billion

    Bristol Myers Squibb will acquire radiopharmaceutical therapeutics company RayzeBio for $62.50 a share in cash.

    Continue reading this article with a Barron’s subscription.

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  • Bluebird Bio Stock Is in Free Fall

    Bluebird Bio Stock Is in Free Fall

    Two weeks ago, bluebird bio secured Food and Drug Administration approval for its gene therapy for sickle cell disease, a significant milestone for the roughly 100,000 people in the U.S. who suffer from the condition.

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  • Alphabet, Heico, Bluebird Bio, Plug Power, UBS, FedEx, and More Stock Market Movers

    Alphabet, Heico, Bluebird Bio, Plug Power, UBS, FedEx, and More Stock Market Movers

    Stock futures traded flat Tuesday, a day after the S&P 500 finished up 0.5% and moved closer to its all-time. The broad market index stands just 1.2% below its record of 4,796.56 reached in early January 2022.

    Continue reading this article with a Barron’s subscription.

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  • AbbVie to acquire neuroscience drugmaker Cerevel Therapeutics for $8.7 billion

    AbbVie to acquire neuroscience drugmaker Cerevel Therapeutics for $8.7 billion

    AbbVie on Wednesday said it will acquire neuroscience drugmaker Cerevel Therapeutics for roughly $8.7 billion. 

    Under the terms of the deal, AbbVie will pay $45 per share for Cerevel. AbbVie said it expects to complete the acquisition in the middle of 2024. 

    Shares of Cerevel jumped 16% after the close Wednesday to nearly $43 per share, just below the purchase price. Shares of Abbvie were down less than 1% in extended trading.

    The deal is AbbVie’s latest attempt to expand its drug pipeline as its top-selling treatments, such as Humira, face generic competition. Just last week, AbbVie agreed to buy cancer drug developer Immunogen for nearly $10 billion. 

    Cerevel will specifically beef up AbbVie’s portfolio for psychiatric and neurological disorders “where significant unmet needs remain,” according to a release from AbbVie. 

    Cerevel will bring over drugs such as Emraclidine, an experimental treatment for both schizophrenia and Alzheimer’s disease psychosis, including symptoms like hallucinations and delusion. That drug is currently in a phase one study in elderly volunteers. 

    “Our existing neuroscience portfolio and our combined pipeline with Cerevel represents a significant growth opportunity well into the next decade,” said Richard Gonzalez, CEO and chairman of AbbVie, in a statement. “AbbVie will leverage its deep commercial capabilities, international infrastructure, and regulatory and clinical expertise to deliver substantial shareholder value with multibillion-dollar sales potential across Cerevel’s portfolio of assets.”

    AbbVie said it will hold an investor conference call about the deal on Thursday at 8:00 a.m. ET.

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  • No antibiotics worked, so this woman turned to a natural enemy of bacteria to save her husband's life | CNN

    No antibiotics worked, so this woman turned to a natural enemy of bacteria to save her husband's life | CNN



    CNN
     — 

    In February 2016, infectious disease epidemiologist Steffanie Strathdee was holding her dying husband’s hand, watching him lose an exhausting fight against a deadly superbug infection.

    After months of ups and downs, doctors had just told her that her husband, Tom Patterson, was too racked with bacteria to live.

    “I told him, ‘Honey, we’re running out of time. I need to know if you want to live. I don’t even know if you can hear me, but if you can hear me and you want to live, please squeeze my hand.’

    “All of a sudden, he squeezed really hard. And I thought, ‘Oh, great!’ And then I’m thinking, ‘Oh, crap! What am I going to do?’”

    What she accomplished next could easily be called miraculous. First, Strathdee found an obscure treatment that offered a glimmer of hope — fighting superbugs with phages, viruses created by nature to eat bacteria.

    Then she convinced phage scientists around the country to hunt and peck through molecular haystacks of sewage, bogs, ponds, the bilge of boats and other prime breeding grounds for bacteria and their viral opponents. The impossible goal: quickly find the few, exquisitely unique phages capable of fighting a specific strain of antibiotic-resistant bacteria literally eating her husband alive.

    Next, the US Food and Drug Administration had to greenlight this unproven cocktail of hope, and scientists had to purify the mixture so that it wouldn’t be deadly.

    Yet just three weeks later, Strathdee watched doctors intravenously inject the mixture into her husband’s body — and save his life.

    Their story is one of unrelenting perseverance and unbelievable good fortune. It’s a glowing tribute to the immense kindness of strangers. And it’s a story that just might save countless lives from the growing threat of antibiotic-resistant superbugs — maybe even your own.

    “It’s estimated that by 2050, 10 million people per year — that’s one person every three seconds — is going to be dying from a superbug infection,” Strathdee told an audience at Life Itself, a 2022 health and wellness event presented in partnership with CNN.

    “I’m here to tell you that the enemy of my enemy can be my friend. Viruses can be medicine.”

    sanjay pkg vpx

    How this ‘perfect predator’ saved his life after nine months in the hospital

    During a Thanksgiving cruise on the Nile in 2015, Patterson was suddenly felled by severe stomach cramps. When a clinic in Egypt failed to help his worsening symptoms, Patterson was flown to Germany, where doctors discovered a grapefruit-size abdominal abscess filled with Acinetobacter baumannii, a virulent bacterium resistant to nearly all antibiotics.

    Found in the sands of the Middle East, the bacteria were blown into the wounds of American troops hit by roadside bombs during the Iraq War, earning the pathogen the nickname “Iraqibacter.”

    “Veterans would get shrapnel in their legs and bodies from IED explosions and were medevaced home to convalesce,” Strathdee told CNN, referring to improvised explosive devices. “Unfortunately, they brought their superbug with them. Sadly, many of them survived the bomb blasts but died from this deadly bacterium.”

    Today, Acinetobacter baumannii tops the World Health Organization’s list of dangerous pathogens for which new antibiotics are critically needed.

    “It’s something of a bacterial kleptomaniac. It’s really good at stealing antimicrobial resistance genes from other bacteria,” Strathdee said. “I started to realize that my husband was a lot sicker than I thought and that modern medicine had run out of antibiotics to treat him.”

    With the bacteria growing unchecked inside him, Patterson was soon medevaced to the couple’s hometown of San Diego, where he was a professor of psychiatry and Strathdee was the associate dean of global health sciences at the University of California, San Diego.

    “Tom was on a roller coaster — he’d get better for a few days, and then there would be a deterioration, and he would be very ill,” said Dr. Robert “Chip” Schooley, a leading infectious disease specialist at UC San Diego who was a longtime friend and colleague. As weeks turned into months, “Tom began developing multi-organ failure. He was sick enough that we could lose him any day.”

    Patterson's body was systemically infected with a virulent drug-resistant bacteria that also infected troops in the Iraq War, earning the pathogen the nickname

    After that reassuring hand squeeze from her husband, Strathdee sprang into action. Scouring the internet, she had already stumbled across a study by a Tbilisi, Georgia, researcher on the use of phages for treatment of drug-resistant bacteria.

    A phone call later, Strathdee discovered phage treatment was well established in former Soviet bloc countries but had been discounted long ago as “fringe science” in the West.

    “Phages are everywhere. There’s 10 million trillion trillion — that’s 10 to the power of 31 — phages that are thought to be on the planet,” Strathdee said. “They’re in soil, they’re in water, in our oceans and in our bodies, where they are the gatekeepers that keep our bacterial numbers in check. But you have to find the right phage to kill the bacterium that is causing the trouble.”

    Buoyed by her newfound knowledge, Strathdee began reaching out to scientists who worked with phages: “I wrote cold emails to total strangers, begging them for help,” she said at Life Itself.

    One stranger who quickly answered was Texas A&M University biochemist Ryland Young. He’d been working with phages for over 45 years.

    “You know the word persuasive? There’s nobody as persuasive as Steffanie,” said Young, a professor of biochemistry and biophysics who runs the lab at the university’s Center for Phage Technology. “We just dropped everything. No exaggeration, people were literally working 24/7, screening 100 different environmental samples to find just a couple of new phages.”

    While the Texas lab burned the midnight oil, Schooley tried to obtain FDA approval for the injection of the phage cocktail into Patterson. Because phage therapy has not undergone clinical trials in the United States, each case of “compassionate use” required a good deal of documentation. It’s a process that can consume precious time.

    But the woman who answered the phone at the FDA said, “‘No problem. This is what you need, and we can arrange that,’” Schooley recalled. “And then she tells me she has friends in the Navy that might be able to find some phages for us as well.”

    In fact, the US Naval Medical Research Center had banks of phages gathered from seaports around the world. Scientists there began to hunt for a match, “and it wasn’t long before they found a few phages that appeared to be active against the bacterium,” Strathdee said.

    Dr. Robert

    Back in Texas, Young and his team had also gotten lucky. They found four promising phages that ravaged Patterson’s antibiotic-resistant bacteria in a test tube. Now the hard part began — figuring out how to separate the victorious phages from the soup of bacterial toxins left behind.

    “You put one virus particle into a culture, you go home for lunch, and if you’re lucky, you come back to a big shaking, liquid mess of dead bacteria parts among billions and billions of the virus,” Young said. “You want to inject those virus particles into the human bloodstream, but you’re starting with bacterial goo that’s just horrible. You would not want that injected into your body.”

    Purifying phage to be given intravenously was a process that no one had yet perfected in the US, Schooley said, “but both the Navy and Texas A&M got busy, and using different approaches figured out how to clean the phages to the point they could be given safely.”

    More hurdles: Legal staff at Texas A&M expressed concern about future lawsuits. “I remember the lawyer saying to me, ‘Let me see if I get this straight. You want to send unapproved viruses from this lab to be injected into a person who will probably die.’ And I said, “Yeah, that’s about it,’” Young said.

    “But Stephanie literally had speed dial numbers for the chancellor and all the people involved in human experimentation at UC San Diego. After she calls them, they basically called their counterparts at A&M, and suddenly they all began to work together,” Young added.

    “It was like the parting of the Red Sea — all the paperwork and hesitation disappeared.”

    The purified cocktail from Young’s lab was the first to arrive in San Diego. Strathdee watched as doctors injected the Texas phages into the pus-filled abscesses in Patterson’s abdomen before settling down for the agonizing wait.

    “We started with the abscesses because we didn’t know what would happen, and we didn’t want to kill him,” Schooley said. “We didn’t see any negative side effects; in fact, Tom seemed to be stabilizing a bit, so we continued the therapy every two hours.”

    Two days later, the Navy cocktail arrived. Those phages were injected into Patterson’s bloodstream to tackle the bacteria that had spread to the rest of his body.

    “We believe Tom was the first person to receive intravenous phage therapy to treat a systemic superbug infection in the US,” Strathdee told CNN.

    “And three days later, Tom lifted his head off the pillow out of a deep coma and kissed his daughter’s hand. It was just miraculous.”

    Patterson awoke from a coma after receiving an intravenous dose of phages tailored to his bacteria.

    Today, nearly eight years later, Patterson is happily retired, walking 3 miles a day and gardening. But the long illness took its toll: He was diagnosed with diabetes and is now insulin dependent, with mild heart damage and gastrointestinal issues that affect his diet.

    “He isn’t back surfing again, because he can’t feel the bottoms of his feet, and he did get Covid-19 in April that landed him in the hospital because the bottoms of his lungs are essentially dead,” Strathdee said.

    “As soon as the infection hit his lungs he couldn’t breathe and I had to rush him to the hospital, so that was scary,” she said. “He remains high risk for Covid but we’re not letting that hold us hostage at home. He says, ‘I want to go back to having as normal life as fast as possible.’”

    To prove it, the couple are again traveling the world — they recently returned from a 12-day trip to Argentina.

    “We traveled with a friend who is an infectious disease doctor, which gave me peace of mind to know that if anything went sideways, we’d have an expert at hand,” Strathdee said.

    “I guess I’m a bit of a helicopter wife in that sense. Still, we’ve traveled to Costa Rica a couple of times, we’ve been to Africa, and we’re planning to go to Chile in January.”

    Patterson’s case was published in the journal Antimicrobial Agents and Chemotherapy in 2017, jump-starting new scientific interest in phage therapy.

    “There’s been an explosion of clinical trials that are going on now in phage (science) around the world and there’s phage programs in Canada, the UK, Australia, Belgium, Sweden, Switzerland, India and China has a new one, so it’s really catching on,” Strathdee told CNN.

    Some of the work is focused on the interplay between phages and antibiotics — as bacteria battle phages they often shed their outer shell to keep the enemy from docking and gaining access for the kill. When that happens, the bacteria may be suddenly vulnerable to antibiotics again.

    “We don’t think phages are ever going to entirely replace antibiotics, but they will be a good adjunct to antibiotics. And in fact, they can even make antibiotics work better,” Strathdee said.

    In San Diego, Strathdee and Schooley opened the Center for Innovative Phage Applications and Therapeutics, or IPATH, in 2018, where they treat or counsel patients suffering from multidrug-resistant infections. The center’s success rate is high, with 82% of patients undergoing phage therapy experiencing a clinically successful outcome, according to its website.

    Schooley is running a clinical trial using phages to treat patients with cystic fibrosis who constantly battle Pseudomonas aeruginosa, a drug-resistant bacteria that was also responsible for the recent illness and deaths connected to contaminated eye drops manufactured in India.

    And a memoir the couple published in 2019 — “The Perfect Predator: A Scientist’s Race to Save Her Husband From a Deadly Superbug” — is also spreading the word about these “perfect predators” to what may soon be the next generation of phage hunters.

    VS Phages Sanjay Steffanie

    How naturally occurring viruses could help treat superbug infections

    “I am getting increasingly contacted by students, some as young as 12,” Strathdee said. “There’s a girl in San Francisco who begged her mother to read this book and now she’s doing a science project on phage-antibiotic synergy, and she’s in eighth grade. That thrills me.”

    Strathdee is quick to acknowledge the many people who helped save her husband’s life. But those who were along for the ride told CNN that she and Patterson made the difference.

    “I think it was a historical accident that could have only happened to Steffanie and Tom,” Young said. “They were at UC San Diego, which is one of the premier universities in the country. They worked with a brilliant infectious disease doctor who said, ‘Yes,’ to phage therapy when most physicians would’ve said, ‘Hell, no, I won’t do that.’

    “And then there is Steffanie’s passion and energy — it’s hard to explain until she’s focused it on you. It was like a spiderweb; she was in the middle and pulled on strings,” Young added. “It was just meant to be because of her, I think.”

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  • Free ChatGPT may incorrectly answer drug questions, study says

    Free ChatGPT may incorrectly answer drug questions, study says

    Harun Ozalp | Anadolu | Getty Images

    The free version of ChatGPT may provide inaccurate or incomplete responses — or no answer at all — to questions related to medications, which could potentially endanger patients who use OpenAI’s viral chatbot, a new study released Tuesday suggests.

    Pharmacists at Long Island University who posed 39 questions to the free ChatGPT in May deemed that only 10 of the chatbot’s responses were “satisfactory” based on criteria they established. ChatGPT’s responses to the 29 other drug-related questions did not directly address the question asked, or were inaccurate, incomplete or both, the study said. 

    The study indicates that patients and health-care professionals should be cautious about relying on ChatGPT for drug information and verify any of the responses from the chatbot with trusted sources, according to lead author Sara Grossman, an associate professor of pharmacy practice at LIU. 

    For patients, that can be their doctor or a government-based medication information website such as the National Institutes of Health’s MedlinePlus, she said.

    An OpenAI spokesperson said the company guides ChatGPT to inform users that they “should not rely on its responses as a substitute for professional medical advice or traditional care.”

    The spokesperson also shared a section of OpenAI’s usage policy, which states that the company’s “models are not fine-tuned to provide medical information.” People should never use ChatGPT to provide diagnostic or treatment services for serious medical conditions, the usage policy said.

    ChatGPT was widely seen as the fastest-growing consumer internet app of all time following its launch roughly a year ago, which ushered in a breakout year for artificial intelligence. But along the way, the chatbot has also raised concerns about issues including fraud, intellectual property, discrimination and misinformation. 

    Several studies have highlighted similar instances of erroneous responses from ChatGPT, and the Federal Trade Commission in July opened an investigation into the chatbot’s accuracy and consumer protections. 

    In October, ChatGPT drew around 1.7 billion visits worldwide, according to one analysis. There is no data on how many users ask medical questions of the chatbot.

    Notably, the free version of ChatGPT is limited to using data sets through September 2021 — meaning it could lack significant information in the rapidly changing medical landscape. It’s unclear how accurately the paid versions of ChatGPT, which began to use real-time internet browsing earlier this year, can now answer medication-related questions.  

    Grossman acknowledged there’s a chance that a paid version of ChatGPT would have produced better study results. But she said that the research focused on the free version of the chatbot to replicate what more of the general population uses and can access. 

    She added that the study provided only “one snapshot” of the chatbot’s performance from earlier this year. It’s possible that the free version of ChatGPT has improved and may produce better results if the researchers conducted a similar study now, she added.

    Grossman noted that the research, which was presented at the American Society of Health-System Pharmacists’ annual meeting on Tuesday, did not require any funding. ASHP represents pharmacists across the U.S. in a variety of health-care settings.

    ChatGPT study results

    The study used real questions posed to Long Island University’s College of Pharmacy drug information service from January 2022 to April of this year. 

    In May, pharmacists researched and answered 45 questions, which were then reviewed by a second researcher and used as the standard for accuracy against ChatGPT. Researchers excluded six questions because there was no literature available to provide a data-driven response. 

    ChatGPT did not directly address 11 questions, according to the study. The chatbot also gave inaccurate responses to 10 questions, and wrong or incomplete answers to another 12. 

    For each question, researchers asked ChatGPT to provide references in its response so that the information provided could be verified. However, the chatbot provided references in only eight responses, and each included sources that don’t exist.

    One question asked ChatGPT about whether a drug interaction — or when one medication interferes with the effect of another when taken together — exists between Pfizer‘s Covid antiviral pill Paxlovid and the blood-pressure-lowering medication verapamil.

    ChatGPT indicated that no interactions had been reported for that combination of drugs. In reality, those medications have the potential to excessively lower blood pressure when taken together.  

    “Without knowledge of this interaction, a patient may suffer from an unwanted and preventable side effect,” Grossman said. 

    Grossman noted that U.S. regulators first authorized Paxlovid in December 2021. That’s a few months before the September 2021 data cutoff for the free version of ChatGPT, which means the chatbot has access to limited information on the drug. 

    Still, Grossman called that a concern. Many Paxlovid users may not know the data is out of date, which leaves them vulnerable to receiving inaccurate information from ChatGPT. 

    Another question asked ChatGPT how to convert doses between two different forms of the drug baclofen, which can treat muscle spasms. The first form was intrathecal, or when medication is injected directly into the spine, and the second form was oral. 

    Grossman said her team found that there is no established conversion between the two forms of the drug and it differed in the various published cases they examined. She said it is “not a simple question.” 

    But ChatGPT provided only one method for the dose conversion in response, which was not supported by evidence, along with an example of how to that conversion. Grossman said the example had a serious error: ChatGPT incorrectly displayed the intrathecal dose in milligrams instead of micrograms

    Any health-care professional who follows that example to determine an appropriate dose conversion “would end up with a dose that’s 1,000 times less than it should be,” Grossman said. 

    She added that patients who receive a far smaller dose of the medicine than they should be getting could experience a withdrawal effect, which can involve hallucinations and seizures

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  • Drug Makers Struggle to Replace Stimulants with Non-Addictive Alternatives | High Times

    Drug Makers Struggle to Replace Stimulants with Non-Addictive Alternatives | High Times

    Unfortunately, the same drugs with high potential for abuse are also the ones that work best for certain individuals with neurobehavioral conditions. According to GlobalData, penetrating the stimulant-dominated pharmaceutical market remains challenging without comparable efficacy from non-stimulants. 

    The attention deficit hyperactivity disorder (ADHD) market is a lucrative business: Stimulants, amphetamines, and methylphenidates continue to dominate the ADHD drug market across the seven major markets, Express Pharma reports. (The seven major markets are in France, Germany, Italy, Spain, the UK, the US, and Japan.)

    Non-addictive drugs demonstrate a “crippling lower” efficacy in treating ADHD.

    Drug makers are in a race to develop safer alternatives. Three out of the four late-stage pipeline drug candidates in Phase III development within those markets have non-stimulant properties: Axsome Therapeutics Inc’s solriamfetol, Otsuka Pharmaceutical Co Ltd’s centanafadine and Neurocentria Inc’s L-Threonate Magnesium Salt. 

    The lower abuse potential of solriamfetol and centanafadine is a major selling point created by developers, but without displaying efficacy comparable to stimulants, they will struggle to penetrate the market—even if they are approved.

    The use of stimulants for ADHD treatment is increasing.

    The key opinion leaders (KOLs) in the treatment of ADHD say that patients and parents have been hesitant to use stimulants for the treatment of ADHD in children and adolescents, but this is changing with time, and the use of stimulants for ADHD treatment is increasing.

    “Marketing emphasis on abuse potential is common in non-stimulates both marketed and pipeline; this is despite KOLs viewing the abuse potential of ADHD stimulants as overstated,” said Lorraine Palmer, Pharma Analyst at GlobalData. “The KOLs interviewed by GlobalData were not concerned about whether a treatment is a stimulant or a non-stimulant, rather they are focused on the pharmaceuticals efficacy and side-effect profile.”

    Four non-stimulants are commonly marketed: guanfacine, clonidine, atomoxetine and viloxazine. Sleep disturbances and a decreased appetite have been reported from both clonidine and atomoxetine. 

    “All four display cripplingly lower efficacy in the treatment of ADHD than stimulants,” Express Pharma reports.

    “Rather than an emphasis on abuse potential, a better alternative strategy to penetrate the saturated ADHD market would be to target key unmet needs in ADHD treatment such as improving compliance or providing coverage into the evening without affecting sleep.”

    Part of this challenge likely includes the impact of addiction itself.  Regarding the popular ADHD drug Adderall, adults and children 6 years of age and older are eligible to take Adderall, beginning at 5 milligrams, while children 3 to 5 years of age are able to start at 2.5 mg per day. Only children under the age of 3 are prohibited from being prescribed the drug in all cases.

    Adderall’s active ingredients are dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. Columbia University psychiatry professor Carl Hart famously wrote for Vice in 2016 that meth is “almost identical to Adderall” in terms of chemistry and its effects on the brain.

    A 2016 study published in the Journal of Clinical Psychiatry indicates that an increasing number of young adults have been checking into emergency rooms over the past few years due to accidental overdoses on Adderall and similar drugs.

    Other Reasons for Stimulant Alternatives

    High Times reported last September that leading drug makers and pharmaceutical companies are having little luck addressing nationwide shortages of stimulant-based ADHD medications like Adderall, Vyvanse, and Ritalin.

    The Adderall shortage began in Fall of 2022, marked by an FDA notice acknowledging the shortages with an estimate that things would be resolved in a month or two. That is not the case, however, as issued a joint notice on August 1 acknowledging that the shortage had been “understandably frustrating” for patients and providers.

    “The current shortage of stimulant medications is the result of many factors. It began last fall due to a manufacturing delay experienced by one drug maker,” the joint notice said. “While this delay has since resolved, we are continuing to experience its effects in combination with record-high prescription rates of stimulant medications. Data show that, from 2012 to 2021, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5 percent in the United States.” 

    Teva Pharmaceuticals, Adderall’s biggest manufacturer, reported shortfalls. Teva CEO Richard Francis told Bloomberg that the company is operating at “full capacity” at the moment and blamed their decreased output in previous years to COVID-induced work shortages which they have only just barely recovered from. Should they wish to increase the amount of Adderall they produce, they would have to buy or build more factories as their current infrastructure cannot handle bigger output. The company has declined to comment on whether or not they plan to invest in such infrastructure.

    This adds to the multiple reasons less addictive non-stimulant drugs are needed to treat ADHD.

    Benjamin M. Adams

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  • Roche's Inavolisib Breast Cancer Drug Shows Promise in Late-Stage Study

    Roche's Inavolisib Breast Cancer Drug Shows Promise in Late-Stage Study

    By Mauro Orru

    Roche Holding said its investigational treatment, inavolisib, showed promise in a late-stage study to treat patients with breast cancer.

    The Swiss pharmaceutical company said Tuesday that the phase 3 study met its primary endpoint of progression-free survival, showing that inavolisib, in combination with palbociclib and fulvestrant, delivered a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone.

    While Roche acknowledged that overall survival data were immature at this stage, it said it had observed a clear positive trend. The inavolisib combination was well tolerated.

    The group said inavolisib is an investigational, oral targeted treatment with potential to provide durable disease control.

    Write to Mauro Orru at mauro.orru@wsj.com

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