Ineffective Cancer Drugs, Menthol Cigarettes In FDA’s Sights
This Tuesday, the FDA will convene a meeting to reconsider approvals given to some decades-old cancer drugs that have not proved effective over time. A potential ban of menthol cigarettes is also on the table this week.
AP:
FDA To Scrutinize Unproven Cancer Drugs After 10-Year Gap
Each year the U.S. approves dozens of new uses for cancer drugs based on early signs that they can shrink or slow the spread of tumors. But how often do those initial results translate into longer, healthier lives for patients? That seemingly simple question is one of the thorniest debates in medicine. It spills into public view Tuesday as the Food and Drug Administration convenes the first meeting in a decade to consider clawing back approvals from several cancer drugs that have failed to show they extend or improve life. (Perrone, 4/25)
Stat:
The FDA Will This Week Decide Whether To Ban Menthol Cigarettes
The Food and Drug Administration will decide this week whether to ban menthol cigarettes — a seeming end to a decadeslong, five-way brawl between cigarette makers, public health advocates, regulators, lawmakers, and federal judges. But in reality, no one is done throwing punches: Regardless of what the FDA decides, the fight will only intensify in the coming months. (Florko, 4/26)
Bloomberg:
Bristol-Myers Psoriasis Drug Shows Promise In Late-Stage Trials
Bristol-Myers Squibb Co.’s experimental psoriasis drug showed positive results in two late-stage trials, potentially setting it up as future rival to Otezla, Amgen Inc.’s billion-dollar pill. Bristol’s deucravacitinib is a TYK2 inhibitor for the treatment of patients with moderate to severe plaque psoriasis. Significantly more patients treated with the drug showed superior results for disease severity and skin clearance compared with those on a placebo, the company said Friday in a statement. (Rutherford, 4/23)
In research news —
The Boston Globe:
As Hopes Rise For Pandemic’s Close, Some Are Preparing For Never-Ending COVID
A pandemic-weary public is dreaming of Memorial Day barbecues, summer nights at Fenway Park, and putting the long-running curse of COVID-19 behind us. But in the medical and biopharma worlds, many are eyeing a more daunting prospect: coronavirus as a never-ending threat. Governments and private investors who once shunned vaccines as an unprofitable pharmaceutical backwater are pouring billions into venerable drug giants and upstart biotechs, including some in Massachusetts, seeking to develop longer-lasting vaccines. (Weisman and Saltzman, 4/24)
Stat:
Covid-19 Gave Scientists A Way To Study How Brain Disorders Arise
While the Covid-19 pandemic put many human research studies on hold, neuroscientist Grainne McAlonan of Kings College London saw it as a fortuitous opportunity — a chance to accelerate her search for early signs of neurodevelopmental disorders in fetuses and newborns. McAlonan knew that if a mother is infected by a virus during pregnancy, her child has a slightly greater chance of developing such disorders, including autism, although the overall risk is very low. The novel coronavirus gave her a way to study how viral infection and the immune response affect the developing brain, and why a small number of infants are susceptible to neurological changes while the vast majority are not. (Reardon, 4/26)
