Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’
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CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)
In a surprise move, Biogen announced Monday that it will cut the price of its controversial Alzheimer’s drug Aduhelm in half, slashing the cost from $56,000 to $28,000.
The sudden discount marks a sudden turnaround for the big biotech as it struggles to turn around a drug whose stuck-in-the-mud sales and political ramifications have sent the company into turmoil and triggered the ousting of its longtime chief scientist. Biogen’s leadership had resisted calls since June to reduce the price of the drug.
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Graphic: Alexander Lefterov for Endpoints News
Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.
In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.
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Angie You and Volker Schellenberger, Amunix
Sanofi is crashing the year-end M&A party with a deal of its own.
Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’
‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’
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New research from Johns Hopkins shows convalescent plasma may work in the outpatient space, which could be key as the Omicron variant has extinguished several monoclonal antibody treatments.
The results of this placebo-controlled, multicenter trial led by Hopkins researchers showed that convalescent plasma reduced the need for hospitalization among more than 1,000 outpatients with Covid-19 who participated.
The FDA may soon sign off on two new pills from Merck and Pfizer to help treat Covid-19 before those infected end up in the hospital, according to a Bloomberg report.
An announcement from the agency may come as early as Wednesday, according to three Bloomberg sources, which would create more options for those who are unvaccinated and need quick and early treatment.
Most recently, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the Merck pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms. But Merck offered little explanation for why its potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, and mutagenesis concerns remain.
A long-acting injectable treatment for the prevention of HIV has been given the go-ahead by the FDA for use in adults and children weighing at least 77 pounds.
Apretude is first given as two injections given a month apart from each other, and then every two months after. Patients are given the option to start treatment with Apretude or the oral cabotegravir Vocabria for four weeks to assess how well to tolerate the drug.
The director of the gastrointestinal oncology program at the University of Chicago Medical Center has been charged by the US attorney in Chicago with insider trading after he made more than $134,000 from stock trades based on an early look at the results of a Five Prime Therapeutics trial.
The US attorney’s office said yesterday that back in early November 2020, Daniel Catenacci, a University of Chicago associate professor with more than a decade of experience who worked with Five Prime on early trials, purchased more than 8,700 shares of the company the morning before it announced positive results from a Phase II trial in treating advanced gastric/gastroesophageal cancer.
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A young man with Duchenne muscular dystrophy has died in Pfizer’s Phase Ib trial of its mini-dystrophin gene therapy, triggering a halt in screening and dosing — and a clinical hold imposed by the FDA.
Pfizer informed the Parent Project Muscular Dystrophy of the death in a community letter. The patient was participating in the non-ambulatory cohort of the trial, the company wrote, adding:
At this time, we do not yet have complete information and are actively working with the trial siteinvestigator to understand what happened.
https://endpts.com/alzheimers-experts-call-on-fda-to-pull-biogens-aduhelm/
