Drugmakers’ Reversals Spark Debate Over FDA’s Accelerated Approvals
A trial of Tecentriq, a Roche drug that was granted accelerated approval in 2016 to treat bladder cancer, has shown that the drug failed to improve overall survival, Stat reports. Last month, AstraZeneca experienced a similar problem with Imfinzi.
Stat:
Two Drug Makers Withdraw Bladder Cancer Indications
For the second time in less than a month, a drug maker has pulled an indication for a medicine after a follow-up clinical trial failed to meet its primary goal. And the moves come as part of a U.S. regulatory review of so-called accelerated approvals, a controversial strategy that has been used to hasten availability of treatments for serious conditions. (Silverman, 3/8)
In other pharmaceutical and research news —
Stat:
With Data Looming, Rubius Therapeutics Seeks To Shed Its Bumbling Image
Rubius Therapeutics is the can’t-do-anything-right biotech spinout from the high-profile venture capital firm Flagship Pioneering. Moderna — Flagship’s runaway success story — it is not. But an opportunity for Rubius to improve its bumbling reputation — and continue a recent recovery in its stock price — looms. The company is preparing to disclose the first clinical data from an effort to transform red blood cells into cancer-fighting drugs. (Feuerstein, 3/9)
The Washington Post:
Can Some Drugs Delay Aging? Scientists Focus On Those That Target Frailty And Age-Related Disease.
In fall 2014, about two dozen geroscientists — researchers who study the confluence of aging, biology and disease — gathered in a remote 15th-century Spanish castle-turned-luxury hotel in the province of Toledo to discuss turning a provocative idea into reality: a study in humans showing that a drug could put the brakes on aging. In recent years, many experts in the aging field have come to believe that certain medications acting at the cellular and metabolic level can slow aging by staving off its most striking effects — frailty and age-related diseases, for example — and extend healthy life in doing so. Now they are setting out to prove it. (Cimons, 3/6)
CNN:
Why Are Whales Much More Cancer-Resistant Than Humans? The Answer Is In Their Genes, New Study Suggests
Cancer should be a near certainty for whales, the longest-living and largest mammals there are -- but scientists are finding that cetaceans are excellent at protecting themselves against the deadly disease. Just how do they do that? It could all come down to good genes, according to a new study published by The Royal Society. (Giuliani-Hoffman, 3/5)
