FDA Panel Says Pfizer’s Injectable Osteoarthritis Drug Is Too Risky
The vote did not address whether the FDA should approve the drug, called tanezumab, and the agency isn't required to follow the panel's advice, Stat reports.
Stat:
FDA Panel Says Risks Of Pfizer Pain Drug Outweigh The Benefits
A panel of expert advisers to the Food and Drug Administration on Thursday concluded that the risks of an investigational pain treatment from Pfizer might outweigh its benefits — likely a major obstacle to the drug’s approval. The treatment, an injectable painkiller that has been studied in osteoarthritis, has been linked to rare but serious cases of joint damage. Pfizer proposed a post-approval plan to mitigate those dangers, but in a 19-1 vote, the FDA’s assembled experts found that the company’s proposal would be insufficient to keep patients safe. (Garde, 3/25)
Stat:
EPA Rule On Citrus Farming Challenged Over Antibiotic Resistance Concerns
Amid rising concern over antibiotic resistance, a coalition of advocacy groups has filed a lawsuit to stop the Environmental Protection Agency from letting citrus farmers spray streptomycin in hopes of preventing or treating diseases that harm their trees. The move comes after the EPA significantly expanded use of the medically important antibiotic on citrus trees in California, Texas, and other states where citrus is grown. However, the groups argue this will contribute to antibiotic resistance by causing germs to mutate and eventually harm countless people. And they allege the EPA failed to ensure that the spraying will not harm human health. (Silverman, 3/25)
Stat:
With Time Running Out, ALS Patient Fights With Biogen Over Access To Drug
Earlier this year, Lisa Stockman Mauriello was diagnosed with a fast-moving form of ALS, a fatal neurological disease that gradually causes muscle weakness and paralysis. So her doctor sought to enroll her in a clinical trial for an experimental drug being developed by Biogen (BIIB) called tofersen. But even though he is a clinical investigator in the late-stage study, Biogen would not admit her because enrollment had recently ended. (Silverman, 3/25)
Boston Globe:
Broad Institute Launches $300 Million Effort To Harness AI To Fight Diseases
The Broad Institute of MIT and Harvard is launching a new, $300 million initiative that applies advanced computer science to some of the hardest problems in medicine — an endeavor it said could uncover new ways to fight cancer, infectious disease, and other illness. The Cambridge research center early Thursday announced the creation of the Eric and Wendy Schmidt Center, named for the former Google chief executive and his wife, who are major funders of the effort. (Rosen, 3/25)
