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Roche’s obesity candidate achieves 22.5% weight loss in Phase II; Moderna pulls the plug on late-stage vaccine trials as Health Secretary Robert F. Kennedy’s anti-vaccine policies and rhetoric continues; and embattled gene therapy maker Sarepta announces new data in Duchenne muscular dystrophy.
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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The last few months have been difficult for Gilead, with several late-stage failures and development discontinuations. Amid these problems, Merdad Parsey will be stepping down from his CMO role early next year.
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Three executives whose combined careers include working at companies including Amgen, AstraZeneca, The Janssen Pharmaceutical Companies of Johnson & Johnson, Pfizer and Takeda share their career journeys.
After completing a buyout transaction with The Column Group to remove it from the stock exchange, NGM Bio has raised a $122M Series A to fund a registrational study for a rare liver disease drug and a Phase II trial in hyperemesis gravidarum.
Mid-stage data for 4D Molecular Therapeutics’ wet AMD drug 4D-150 show improvements in visual acuity, reduced injection rate and encouraging safety data.
After nixing a twice-daily version of its oral GLP-1 agonist, Pfizer is hoping to break into the weight-loss space with a once-daily version, but experts question its outlook.
As the yearslong litigation over ownership of CRISPR gene editing continues, investors have forged ahead with funding the technology’s development by biopharma.
Roche’s oral GLP-1 receptor agonist CT-996—obtained in the $2.7 billion acquisition of Carmot Therapeutics—reduced body weight by more than 6% at four weeks versus placebo in a Phase I trial.
As scrutiny of pharmacy benefit managers mounts, a House committee will hold a hearing on the alleged anticompetitive business practices of these middlemen.