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By Anthony O. Goriainoff
AstraZeneca said Thursday that its and MSD’s Lynparza cancer treatment had been approved in the U.S. for the treatment of metastatic castration-resistant prostate cancer, or mCRPC.
The Anglo-Swedish pharma giant said Lynparza, in combination with abiraterone and prednisone, reduced the risk of disease progression or…
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Newswise — Osaka, Japan – While developing a computer program, coding mistakes can lead to software bugs. Likewise, errors in our body’s genetic code, DNA, housed within structures called chromosomes, can trigger alterations in the body. These alterations are responsible for numerous fatal illnesses, including cancer. Presently, Japanese researchers have unveiled fresh insights into a specific kind of genetic alteration: extensive chromosomal reconfiguration (ECR).
In an article published in Communications Biology, a team of researchers from multiple institutions, led by scientists from Osaka University, conducted an analysis on fission yeast to discover two crucial genes associated with the mechanism of ECR.
The scientists were particularly focused on studying the centromere, a crucial region responsible for the separation of chromosomes during cell division. The centromere consists of repetitive DNA sequences, and it is known that ECR tends to happen in regions with repeated DNA sequences. Rad51, an essential enzyme involved in DNA recombination and the exchange of genetic material, was of specific interest. Surprisingly, contrary to expectations, Rad51 actually inhibits rather than facilitates ECR at the centromere. The mechanism by which ECRs occur using the centromere repeat remains mysterious.
“By inducing mutations in Rad51-deficient yeast, which are known to have elevated GCR levels, we aimed to identify genes associated with GCR occurrence,” explained senior author Takuro Nakagawa. “We observed cells with decreased GCR levels and identified mutations in the Srr1 and Skb1 genes. This finding suggests that these genes are involved in the occurrence of GCR.”
Subsequently, the researchers proceeded to delete the Srr1 and Skb1 genes in Rad51-deficient yeast and assessed the occurrence of GCR. The cells lacking Srr1 as well as those lacking Skb1 demonstrated decreased rates of GCR. Furthermore, cells lacking both Srr1 and Skb1 exhibited even lower rates of GCR.
Lead author Piyusha Mongia explained, “Through our analysis, we discovered that Srr1 and Skb1 are implicated in the formation of isochromosomes, a specific type of structural mutation found in chromosomes. Deletion of either Srr1 or Skb1 resulted in a significant decrease in the occurrence of isochromosomes.”
The findings of the research team mark a significant advancement in unraveling the mechanisms that drive GCR at the centromere. Since GCRs are implicated in various genetic disorders, including cancer, gaining insights into the process of GCR formation has the potential to enhance our capacity to treat specific genetic diseases. This represents a crucial step forward in our understanding of GCR and its broader implications for human health.
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The article, “Fission yeast Srr1 and Skb1 promote isochromosome formation at the centromere,” will be published in Communications Biology at DOI: https://doi.org/10.1038/s42003-023-04925-9
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A national obsession with a new class of weight-loss drugs is turning dangerous, doctors and researchers say, as many patients are inappropriately prescribed Wegovy, Ozempic and similar medications and supply shortages generate a market for unauthorized, potentially risky copycat versions of these drugs.
Social media buzz about the drugs has promoted the mistaken perception that the medications are appropriate for a broad swath of people who may want to shed a few pounds–with disastrous consequences for some patients, doctors say. Patients who previously recovered from eating disorders, for example, are coming in for treatment because they “have had their eating disorder reactivated by use of these medications,” said Dr. Elizabeth Wassenaar, a regional medical director at the Eating Recovery Center, which specializes in treating the disorders. Some patients have wound up in the hospital, she said, and in some cases the providers who prescribed the drugs were unaware of the patients’ eating-disorder history. “It’s a real warning to people who prescribe these medications that it’s not without risk,” she said.
Some doctors also question whether the safety of the drugs has been adequately studied in older adults, who may have an undesirable loss of lean muscle mass when taking the medications. That complicates an ongoing debate about whether Medicare should cover these drugs for weight loss.
And patients of all types are put at risk, experts say, by the illegal production of knock-off versions of the medications. The Food and Drug Administration and several state pharmacy boards in recent weeks have warned that some compounding pharmacies are producing unauthorized versions of the drugs–which poses particular safety concerns for injectable drugs such as Wegovy, said David Margraf, a pharmaceutical research scientist with the Resilient Drug Supply Project at the University of Minnesota’s Center for Infectious Disease Research and Policy. “It’s not just a victimless crime,” he said. “People can be severely injured.”
Novo Nordisk
NVO,
the maker of Wegovy and Ozempic, itself sought to tap the brakes on the craze around these drugs in a statement posted on its website this month, saying it’s concerned about reports of the drugs being used “for purely cosmetic or aesthetic weight loss,” unauthorized versions of the drugs hitting the market, and “insufficient clinical evaluations by some telehealth providers” promoting the drugs.
Drugs such as Novo Nordisk’s Wegovy, Ozempic and Rybelsus and Eli Lilly’s
LLY,
Mounjaro mimic the effects of a gut hormone known as GLP-1, which can help control blood-sugar levels and reduce appetite. (Mounjaro also affects another hormone called GIP.) Ozempic, Rybelsus and Mounjaro are FDA-approved for treatment of type 2 diabetes, while Wegovy is approved for people with obesity and certain people with excess weight combined with weight-related medical problems.
Billions of dollars in drug sales hinge on the breadth of the patient population prescribed these medications. Last year, more than 5 million prescriptions for Ozempic, Mounjaro, Rybelsus or Wegovy were written for weight management, up from just 230,000 in 2019, according to data and analytics firm Komodo Health. Obesity drugs could be a $54 billion market by 2030, up from $2.4 billion in 2022, Morgan Stanley said in a report last year. Reports of GLP-1 drug users seeing improvements in addictive behaviors such as smoking and drinking have lately amplified interest in the medications.
The drugs have become such a cultural phenomenon that Walmart during its quarterly earnings call last week blamed the medications for a shift in consumer-spending patterns that pressured its margins. In the first quarter, the company saw “a shift to health and wellness,” John Rainey, Walmart Inc.’s
WMT,
executive vice president and chief financial officer, said on the call with analysts. “And part of that is related to these GLP-1 drugs that are to treat diabetes,” he said, adding that the shift “comes at a lower margin, and so that has some impact on our business as well.”
Noom, a digital health company that for years has emphasized a behavioral approach to weight management, this week announced a new program that will make Ozempic, Wegovy, Mounjaro and other medications available to eligible patients. “Prescriptions are not the goal of our program. They’re very much an adjunct,” Dr. Linda Anegawa, Noom’s chief of medicine, told MarketWatch. Medical professionals will review patients’ entire health history, order labs to assess their metabolic health, and engage in video visits with patients as they determine what treatments might be appropriate, she said.
The reason GLP-1 drugs help control weight is pretty straightforward, said Dr. Daniel Drucker, who helped discover GLP-1 and is senior scientist at Lunenfeld-Tanenbaum Research Institute in Toronto. When people take these drugs, he said, they simply eat less because they feel more full. “GLP-1 will tell your brain that you’re not hungry,” he said, and people taking these medications may feel less stressed about food or find themselves thinking less about food. And the effects may go beyond eating, he said, as some people also see improvements in smoking, drinking, and other addictive or compulsive behaviors. “These are really interesting areas for further investigation,” he said. Drucker has been a consultant or speaker for Novo Nordisk, Pfizer
PFE,
and other pharmaceutical companies.
Novo Nordisk said in a statement to MarketWatch that it is not conducting any dedicated clinical studies to evaluate Ozempic, Rybelsus or Wegovy in patients with substance-use disorders or addiction-related illnesses, and Eli Lilly said it does not have any studies planned for investigating tirzepatide–the active ingredient in Mounjaro–for treatment of addiction.
Adolescents’ use of the drugs for weight loss is a particular concern for some doctors. Wegovy is approved for treatment of obesity in children 12 and older. “The adolescent mental health crisis is unprecedented,” said Wassenaar, with many teens suffering severe mood disorders, eating disorders, and suicidality, and teens struggling with depression may think, “if I lose weight, I’ll feel better and people will like me. There’s this magic drug, and all I have to do is inject it.” And if patients can start taking these drugs as early as 12 years of age, “we just don’t know what that’s going to do to them in 10 or 20 years,” she said, because there’s not enough long-term data.
Novo Nordisk said in a statement to MarketWatch that “teenage obesity is linked to weight-related health problems such as high blood pressure, high cholesterol and type 2 diabetes,” and that cutting calories and increasing physical activity may not be enough for some patients. “The decision to prescribe an anti-obesity medication is at the discretion of the physician and the patient/parents,” the company said.
Eli Lilly said that tirzepatide is not currently being studied for chronic weight management in children or adolescents.
Novo Nordisk via AP
Some doctors are also concerned about broad use of the drugs among older adults. Many older adults have sarcopenia, an age-related loss of muscle mass and strength that can contribute to frailty and fall risk later in life–and losing weight can mean an additional loss of muscle mass that may not be advisable for some patients, doctors and researchers say.
While “there’s a huge push to get Medicare to cover these drugs, it’s not really certain whether they would be helpful in this population or actually more harmful,” said Judy Butler, a research fellow at PharmedOut, a research and education project at Georgetown University Medical Center. Noom is not enrolling patients over age 60 in its new program, Anegawa said, partly because “we really don’t have enough data yet with many of these drugs in the geriatric population.”
In the pivotal clinical trials for Wegovy, 9% of the Wegovy-treated patients were between 65 and 75 years of age, and 1% were 75 and older, Novo Nordisk said in a statement. “No overall differences in safety or effectiveness have been observed between patients 65 years of age and older and younger adult patients,” the company said. In an ongoing cardiovascular outcomes trial, about 38% of patients are 65 or older, the company said.
By law, Medicare generally does not cover drugs prescribed for weight loss–although some drugmakers and industry groups are pushing to change that. Some of the drugs now generating intense demand also come with a hefty sticker price: Wegovy, for example, has an estimated annual net cost of about $13,600, according to the Institute for Clinical and Economic Review. If Medicare coverage rules changed and 10% of beneficiaries with obesity used Wegovy, total annual Medicare Part D spending on the drug could be as much as $26.8 billion, according to a recent study published in the New England Journal of Medicine. That’s more than 18% of the net total Part D spending by beneficiaries and the Medicare program in 2019.
There are potential physical as well as financial costs. Side effects of the drugs can range from nausea and vomiting to gallbladder problems, inflammation of the pancreas, and thyroid cancer.
More broadly, some doctors question the prescribing of drugs solely based on obesity, absent other risk factors. “If somebody is obese and has diabetes, high blood pressure, and high cholesterol, losing weight may improve those parameters, but obesity on its own does not need to be treated,” said Dr. Adriane Fugh-Berman, a professor at Georgetown University Medical Center and director of PharmedOut. “It’s cardiovascular fitness that is important, no matter what weight you are,” she said. “We should stop focusing on the weight itself as a risk factor.”
Dr. Robert Gabbay, chief science and medical officer at the American Diabetes Association, counters that “obesity is a disease, and therefore needs to be treated as such.” Although there are people with obesity who don’t have other serious conditions, he said, “that’s relatively uncommon.”
Despite the concerns, shortages of the drugs persist. Novo Nordisk says it anticipates that many patients will have trouble filling lower-dose Wegovy prescriptions through September.
For patients who are relying on GLP-1 drugs for treatment of diabetes, even a short-term interruption in access to the drugs can cause blood-glucose levels to rise and result in serious complications, Gabbay said. Patients also tend to gradually ramp up dosage of these drugs to get to the effective dose, he said, and if they lose access to the medication “they might have to start back at the beginning again,” putting them several months behind on their treatment.
The shortages can also create risks for a broader set of patients, experts say, as they spur demand for copycat versions of the drugs. The approved active ingredient in Wegovy and Ozempic is semaglutide in its base form, but some compounding pharmacies may be using salt forms of semaglutide, the FDA said in a late April letter to the National Association of Boards of Pharmacy. “We are not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements” restricting the types of active ingredients used in compounding, the FDA said in the letter. Boards of pharmacy in several states, including West Virginia, North Carolina and Mississippi, have also recently issued warnings about compounded semaglutide.
Novo Nordisk said in the statement posted on its website this month that it is “actively monitoring and taking action against” entities unlawfully selling compounded semaglutide, adding that no FDA-approved generic versions of semaglutide currently exist.
Unauthorized compounded versions of the drugs could raise serious concerns about sterility and other quality-control issues, the Resilient Drug Supply Project’s Margraf said. “If this drug is in high demand and there isn’t enough supply, people will find a way to get it from a gray-market source,” he said. “People are going to find ways around the laws and potentially harm patients.”
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Eli Lilly & Co.’s market cap neared Johnson & Johnson’s market cap on Friday, as the stock has benefited from a slew of positive data in trials for key treatments.
Earlier Friday, Lilly stock
LLY,
was on track to close with a greater market capitalization than J&J
JNJ,
which would have marked the first time since 1997. Lilly stock ended flat, however, for the session at $434.43.
The stock has been steadily rising since the release of positive data from a trial of a treatment for Alzheimer’s disease in early May, showing significant slowing of cognitive and function decline in patients with early symptomatic Alzheimer’s disease.
Nearly half, or 7% of participants, had no clinical progression at one year, compared to 29% on placebo. The drug, called donanemab slowed clinical decline by 35% compared to a placebo and resulted in 40% less decline in the ability to perform activities of daily living, including managing finances, driving, engaging in hobbies and conversing about current events, the company said.
The company is planning to proceed with global regulatory submissions as quickly as possible and expects to make a submission to the U.S. Food and Drug Administration this quarter.
For more, see: Eli Lilly stock jumps 5% after Alzheimer’s treatment slows disease progression in major trial
That’s not all. In April, Eli Lilly released data on its new obesity drug tirzepatide that showed patients in a trial losing up to 15.7% of their body weight, or about 34.4 pounds.
More than 80% of people taking tirzepatide lost at least 5% of their body weight, the company said, compared with about 30% of those taking a placebo.
The degree of average weight reduction seen in the trial “has not been previously achieved” in similar Phase 3 trials, Dr. Jeff Emmick, senior vice president for product development at Lilly, said in a statement.
The company is planning regulatory submissions for that drug later this year. Tirzepatide was approved by the FDA last year as Mounjaro, a treatment for Type 2 diabetes.
Lilly has several other pipeline prospects, including lebrikizumab, a treatment for atopic dermatitis; mirikizumab for ulcerative colitis; empagliflozin, a treatment for chronic kidney disease; and pirtobrutinib for relapsed/refractory mantle cell lymphoma.
Lilly’s stock is up about 20% in the year to date and up 50% in the past 12 months.
Johnson & Johnson’s stock, meanwhile, has fallen 9% in the year to date and is down roughly the same over the past 12 months.
The company swung to a first-quarter loss as it booked a multibillion-dollar charge to settle lawsuits stemming from its talc-containing powders.
J&J booked a $6.9 billion one-time litigation charge relating to lawsuits filed by people alleging the company’s talc-containing powders caused cancers, asbestos poisoning and other illnesses. The company has offered to pay at least $8.9 billion to settle the suits, and remove an overhang on the stock.
Read more: J&J’s proposal to settle talc lawsuits for $8.9 billion sends stock up the most in more than a year
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https://www.barrons.com/articles/first-solar-stock-buying-solar-tech-firm-evolar-da85f0b1
First Solar
stock rose sharply Friday as the company disclosed a deal it said would bolster its technological position in the solar energy space.
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Foreign investors and businesspeople with exposure to China are becoming increasingly unnerved. And for good reason.
In March, Chinese authorities detained an employee of Japanese drug manufacturer Astellas Pharma JP:4503 ALPMY for alleged espionage violations. The Chinese seem confident in their case. Beijing’s ambassador to Japan said there was ample evidence of wrongdoing, and, despite the uproar, the Astellas employee remains detained.
That…
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The pandemic opened the floodgates to telehealth. Now, many patients and doctors are curbing their enthusiasm for virtual care.
Four out of five primary-care doctors who had video visits with patients during the pandemic would prefer to provide just a small portion of care or no care at all via telemedicine in the future, according to a survey designed and analyzed by researchers at Harvard T.H. Chan School of Public Health and published last month in Health Affairs, a peer-reviewed journal. And 60% of the doctors surveyed…
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The U.S. Food and Drug Administration said Tuesday it has granted accelerated approval to Biogen Inc.’s torferson, a treatment for a rare form of amyotrophic lateral sclerosis, or ALS.
The accelerated program is used to approve drugs for serious conditions that have an unmet medical need, where a drug is shown to have an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients.
In…
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When is it a good time to buy stocks? Some investors would say the current negativity dominating the financial media means you are better off sitting on the sidelines. Others would say it is always a good time to buy stocks, provided you can get them for good prices.
Count John Buckingham, editor of the Prudent Speculator, in the latter camp. He is a value investor with decades of experience. During an interview, he emphasized the importance of remaining disciplined through all market conditions. While he favors the value…
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During a period of high interest rates, it might be more difficult to impress investors with dividend stocks. But the stocks can have an important advantage over the long term. The dividend payouts can increase over the years, helping to push share prices higher over time.
When considering stocks for dividend income, yield shouldn’t be the only thing you consider. If a stock’s price has tumbled because investors are worried about the company’s business prospects, the dividend yield might be very high. A double-digit yield might mean investors expect to see a cut to the dividend soon.
There are many ways to look at companies’ expected ability to maintain or raise their dividend payouts. But one can also take a simple approach to begin researching stock choices.
At the moment, you can get a bank CD with a yield of close to 5% pretty easily. Here’s a look at current yields for CDs and U.S. Treasury securities and an approach for laddering them not only to protect your cash but to hedge against interest-rate risk.
For investors who would rather aim for long-term growth to go along with dividend income, or take a relatively conservative approach to growth while reinvesting dividends, a screen of stocks in the S&P 500
SPX,
produces only 10 stocks with dividend yields of 4.5% or higher with majority “buy” or equivalent ratings among analysts polled by FactSet. Here they are, sorted by dividend yield:
| Company | Ticker | Dividend Yield | Expected payout increase through 2025 | Share “buy” ratings | April 16 price | Consensus price target | implied 12-month upside potential |
| Comerica Inc. |
CMA, |
6.56% | 10% | 58% | $43.30 | $60.53 | 40% |
| Citizens Financial Group Inc. |
CFG, |
5.77% | 12% | 74% | $29.10 | $39.29 | 35% |
| Healthpeak Properties Inc. |
PEAK, |
5.71% | 9% | 60% | $21.01 | $27.69 | 32% |
| Hasbro Inc. |
HAS, |
5.34% | 8% | 69% | $52.40 | $69.27 | 32% |
| Philip Morris International Inc. |
PM, |
5.11% | 11% | 67% | $99.48 | $113.56 | 14% |
| Realty Income Corp. |
O, |
5.04% | 7% | 56% | $60.77 | $70.00 | 15% |
| Fifth Third Bancorp |
FITB, |
4.99% | 3% | 72% | $26.44 | $34.55 | 31% |
| VICI Properties Inc. |
VICI, |
4.82% | 12% | 95% | $32.35 | $37.73 | 17% |
| Organon & Co. |
OGN, |
4.71% | 5% | 55% | $23.80 | $31.89 | 34% |
| Iron Mountain Inc. |
IRM, |
4.69% | 15% | 78% | $52.76 | $56.00 | 6% |
| Source: FactSet | |||||||
Click on the ticker 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.
The dividend yields for this group of 10 companies are based on current annual regular payout rates, with all paying quarterly except for Realty Income Corp.
O,
which pays monthly.
These two oil and natural gas producers would have passed the above screen based on their most recent dividend payments and analysts’ sentiment, however, they pay a combined fixed-plus-variable dividend every quarter, with the fixed portion relatively low:
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Moderna Inc. said Tuesday it’s working to develop its first bacterial vaccine to protect against Lyme disease, the tick-borne illness that causes a range of painful symptoms, including fever, headaches, fatigue, joint pain and rash.
The biotech
MRNA,
whose first product to be approved by the U.S. Food and Drug Administration was its mRNA-based COVID vaccine, said it has two candidates in development to address Lyme disease, named mRNA-1982 and mRNA-1975.
It announced the news at its fourth Vaccine Day, where it offered a full update on its clinical pipeline, which includes vaccines to protect against flu and respiratory syncytial virus, or RSV, as well as HIV, Epstein-Barr virus and herpes simplex virus, among others.
There are about 120,000 cases of Lyme disease in the U.S. and Europe every year, creating a “significant quality of life burden,” the company said in a statement. Rising temperatures are helping the disease spread more easily, and it is difficult to diagnose, because the symptoms are similar to those of many other diseases. It most seriously affects children below the age of 15 and older adults.
“Older adults appear to have higher odds of unfavorable treatment response as compared with younger patients, and neurologic manifestations are more common at presentation for this older adult population,” said the statement.
The mRNA-1982 candidate is designed to create antibodies for Borrelia burgdorferi, the pathogen that causes almost all Lyme disease in the U.S., while mRNA-1975 is designed to elicit antibodies specific to the four major Borrelia species that cause the disease in the U.S. and Europe.
Other new candidates in Moderna’s pipeline include mRNA-1405 and mRNA-1403, which aim to address the enteric virus norovirus. Norovirus is highly contagious and is the leading cause of diarrheal disease globally, Moderna said. It’s associated with about 18% of all such illnesses worldwide and causes about 200,000 deaths every year.
Overall, Moderna is expecting to launch six major vaccine products in the next few years, all of them with large addressable markets.
The company expects the annual global endemic market for COVID boosters alone to be worth about $15 billion.
It has dosed the first participant in a late-stage trial of its next-generation, refrigerator-stable COVID-19 vaccine candidate, mRNA-1283. The vaccine “has demonstrated encouraging results in multiple clinical studies,” the company said.
See now: Moderna CEO defends price increase for COVID vaccine to Congress
A separate trial of a flu vaccine called mRNA-1010 fared less well, however.
That trial “did not accrue sufficient cases at the interim efficacy analysis to declare early success in the Phase 3 Northern Hemisphere efficacy trial and the independent DSMB recommended continuation of efficacy follow-up,” the company said.
The company expects the market for respiratory-product sales to range from $8 billion to $15 billion by 2027 and for operating profit that year to range from $4 billion to $9 billion.
The stock was down 4% Tuesday and has fallen 15% in the year to date, while the S&P 500
SPX,
has gained 7%.
See also: Moderna’s stock slides as earnings fall short of estimates amid steep decline in COVID-vaccine sales
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AUSTIN, Texas (AP) — A federal judge in Texas on Friday ordered a hold on the U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval.
The abortion drug has been widely used in the U.S. since 2000 and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United…
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Have you got itchy feet?
The U.S. economy added 236,000 jobs in March, just shy of the 238,000 forecast by economists polled by the Wall Street Journal. The unemployment rate declined to 3.5% in March from 3.6% in February.
The latest data was calculated before the collapse of Silicon Valley Bank and Signature Bank last month, an event that…
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https://www.barrons.com/articles/stock-market-movers-88cae2de
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… .wsj.com/articles/marijuana-cannabis-edibles-pot-cbd-health … Original Author Link click here to read complete story.. … Read More
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MMP News Author
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Silicon Valley could use a reboot. The biggest players aren’t growing, and more than a few are seeing sharp revenue declines. Regulators seem opposed to every proposed merger, while legislators push for new rules to crack down on the internet giants. The Justice Department just can’t stop filing antitrust suits against Google. The initial public offering market is closed. Venture-capital investments are plunging, along with valuations of prepublic companies. Maybe they should try turning the whole thing on and off.
The only strategy that seems to be working is to lay people off. Tech CEOs suddenly are channeling Marie Kondo, tidying up and keeping only the people and projects that “spark joy,” or at least support decent operating margins. Layoffs.fyi reports that tech companies have laid off more than 122,000 people already this year.
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https://www.barrons.com/articles/stock-market-movers-5b0c54ae
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