Morning Briefing
Summaries of health policy coverage from major news organizations
Advocacy Group Pushes Gilead To Cancel Voucher For Remdesivir
Stat: Gilead Pressured To Relinquish Voucher Awarded With Remdesivir Approval
A prominent advocacy group is asking Gilead Sciences (GILD) to relinquish a valuable voucher that came with Food and Drug Administration approval of its remdesivir treatment for Covid-19, arguing the voucher is “an entirely unnecessary and an inappropriate incentive” for a drug that has “limited” effectiveness and is already generating huge profits. (Silverman, 11/2)
AP: South African Firm And Johnson & Johnson Strike Vaccine Deal
South African pharmaceutical firm Aspen Pharmacare has announced a deal with U.S. firm Johnson & Johnson to manufacture its COVID-19 vaccine candidate, if it is approved in South Africa and internationally. In a statement issued on Monday, Aspen said that if ongoing trials bring international health authorities to endorse the J&J vaccine as effective and safe, it would be produced at Aspen’s manufacturing facility in Port Elizabeth in South Africa’s Eastern Cape province. (Magome, 11/2)
In other pharmaceutical and biotech developments —
CNN: Metformin Recall: Type 2 Diabetes Drug Recalled Over Contamination With Possible Carcinogen
Two lots of a widely used type 2 diabetes medication, metformin, are being recalled due to possible contamination with a potentially cancer-causing compound. Metformin is designed to lower glucose levels. Nostrum Laboratories Inc., based in Kansas City, Missouri, announced Monday that it is voluntarily recalling its metformin HCl extended release tablets, USP 750 mg, according to a recall posted by the US Drug & Food Administration. (Erdman, 11/3)
Stat: Takeda Hikes Price Of Common Gastrointestinal Drug Again
Two weeks ago, Takeda Pharmaceuticals raised the list price of its Entyvio treatment for ulcerative colitis and Crohn’s disease by 4%, to nearly $7,000 for a vial. This followed an earlier 4% price hike last January, which means the company boosted the list price for its medicine by 8% this year. (Silverman, 11/2)
Stat: Your Guide On How To Prepare For A Historic FDA Meeting On Alzheimer’s
If you follow Alzheimer’s research or have been paying particular attention to the saga over aducanumab, the controversial treatment developed by Biogen, you know that this is a very important week. A panel of experts is convening to decide whether to recommend the Food and Drug Administration approve the drug, which would make it the first new Alzheimer’s treatment in nearly two decades. (Feuerstein and Garde, 11/3)
Stat: 'Stealth' VC Firm Aditum Bio Launches New Biotech Startup
Joe Jimenez, a former Novartis CEO, and Mark Fishman, the former head of the Novartis Institutes for BioMedical Research, announced a new biotech startup on Monday: Tempero Bio. The two are backing Tempero through their venture capital firm, Aditum Bio, which has raised $133 million to spend on four to six other new startups. (Sheridan, 11/2)
Stat: Is Philadelphia’s Biotech Cluster Faltering? Experts Say No
Philadelphia is supposed to be a biotech hub. Two years ago, the city’s life sciences startups brought in more than $450 million; last year, they raised even more. A 2019 Philadelphia Magazine article proclaimed that “even when compared to Silicon Valley, Philadelphia has the most to offer,” and pointed out that more than 80% of leading life sciences companies have offices in the city. But Philly’s growth appears to be slowing. (Sheridan, 11/2)
