ReportWire

Tag: New Product/Service Testing

  • 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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    Novartis Says Kidney Drug Phase 3 Trial Reaches Positive Interim Result
    
			
    Novartis Says Kidney Drug Phase 3 Trial Reaches Positive Interim Result
    
			
    

    

    By Adria Calatayud
    

    Novartis said an interim analysis from a phase 3 trial to evaluate its investigational iptacopan drug in patients with kidney disease nephropathy achieved positive results, meeting its primary goal.
    

    

    The Swiss pharmaceutical company said Monday that an analysis of study data at nine months showed a clinically meaningful and statistically significant reduction in protein in urine. The company said this demonstrated superiority of iptacopan relative to placebo in reducing protein in urine.
    

    The safety profile of the drug was consistent with previously reported data, Novartis said.
    

    Novartis said it plans to review the trial’s interim results with the U.S. Food and Drug Administration to enable a potential regulatory submission for accelerated approval.
    

    The study will now continue to assess the iptacopan’s ability to slow disease progression over two years, the company said. Results from the primary goal at the end of the study are expected in 2025.
    

    Write to Adria Calatayud at adria.calatayud@dowjones.com
    

    

    


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    Roche Lung Cancer Drug Shows Promise in Phase 3 Trial
    
			
    Roche Lung Cancer Drug Shows Promise in Phase 3 Trial
    
			
    

    

    By David Sachs
    

    Roche said Friday that its Alecensa drug demonstrated the ability to reduce recurrence of lung cancer for patients in the early stage of the disease.
    

    The Swiss pharmaceutical company said the results, from a Phase 3 study of 257 people which compared the treatment with platinum-based chemotherapy, met its primary goal of disease-free survival in people with early-stage non-small cell lung cancer. About half of people with this type of lung cancer experience a recurrence of the disease after surgery, Roche said.
    

    

    Roche said that it found no unexpected safety issues and will submit the data to global health authorities.
    

    Write to David Sachs at david.sachs@wsj.com
    

    

    


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    BioVie Shares jump Premarket on Parkinson’s, Alzheimer’s Studies >BIVI
    
			
    BioVie Shares jump Premarket on Parkinson’s, Alzheimer’s Studies >BIVI
    
			
    

    

    By Colin Kellaher
    

    Shares of BioVie Inc. rose sharply in premarket trading Tuesday after the clinical-stage biopharmaceutical company reported positive results from a pair of Phase 2 studies assessing the potential of its NE3107 drug candidate in Parkinson’s disease and Alzheimer’s disease.
    

    

    The Carson City, Nev., company said the study of NE3107 in Parkinson’s met both main objectives, with patients treated with a combination of the drug and levodopa seeing meaningful improvements in their motor score and an absence of adverse interactions of NE3107 with levodopa.
    

    BioVie said that based on the study findings, it will proceed with planning the Phase 3 program for discussion with the U.S. Food and Drug Administration.
    

    Meanwhile, BioVie said patients treated with NE3107 in the Alzheimer’s study experienced improved cognition and biomarker levels, with no drug-related adverse events observed.
    

    BioVie shares, which closed Monday at $5.21, were recently up 15% to $5.98 in premarket trading.
    

    Write to Colin Kellaher at colin.kellaher@wsj.com
    

    

    


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    GSK Says Dreamm-3 Phase 3 Study For Blenrep Didn’t Meet Primary Endpoint
    
			
    GSK Says Dreamm-3 Phase 3 Study For Blenrep Didn’t Meet Primary Endpoint
    
			
    

    

    By Michael Susin
    

    GSK PLC said Monday that its Dreamm-3 Phase 3 study in patients with relapsed or refractory multiple myeloma didn’t meet its primary endpoint of progression-free survival.
    

    The pharmaceutical giant said that the study compared its monotherapy Blenrep versus pomalidomide in combination with low dose dexamethasone and observed median progression-free survival was longer for Blenrep.
    

    

    “These trials are designed to demonstrate the benefit of Blenrep in combination treatment with novel therapies and standard-of-care treatments in earlier lines of therapy and dosing optimization to maintain efficacy while reducing corneal events,” it added.
    

    The company said additional trials will continue and further data from the studies are anticipated in the first half of 2023.
    

    Write to Michael Susin at michael.susin@wsj.com
    

    

    


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    Moderna Stock Takes Off on Cancer Vaccine News
    
			
    Moderna Stock Takes Off on Cancer Vaccine News
    
			
    

    

    
        
    
          
    
            Moderna
    
          
    
        
    
       stock shot up after
    
        
    
          
    
            Merck
    
          
    
        
    
       said it is exercising an option to work on a personalized cancer vaccine with the Covid-19 vaccine maker.
    

    Merck (ticker: MRK) will pay
    
        
    
          
    
            Moderna
    
          
    
        
    
       (MRNA) $250 million for the joint development and future commercialization of the vaccine, which is currently in Phase 2 clinical trials. The two companies had announced a “strategic collaboration” in June 2016.
    

    


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