News
The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in patients with prostate cancer who do not carry HRR mutations.
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Sage Therapeutics discontinued development of its lead candidate dalzanemdor after a third clinical failure, leading analysts to question the biotech’s future profitability.
With two decisions originally scheduled for this week already announced, including BridgeBio’s approval in ATTR-CM, the regulator has just one PDUFA on its plate this holiday week.
ADC Therapeutics, Sutro Biopharma and Zai Lab are among those developing antibody-drug conjugates to address payload and toxicity challenges of current ADCs—and rapidly grow the multibillion-dollar market.
Job Trends
CSL Behring, a business unit of global biotechnology leader CSL, announced the availability of 4- and 5-gram vial sizes for ZEMAIRA®
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
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After some high-profile crashes, the one-time biotech darling is inching toward success with its Hunter syndrome treatment, which today began a rolling BLA for accelerated approval.
With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, there could be a wealth of talent available to biopharma companies. Does this pose an ethical quandary? It depends on who you ask.
Trump has repeatedly called April 2 “Liberation Day,” alluding to a more sweeping and aggressive set of tariffs. Leerink Partners analysts said that the risks from Trump’s tariffs on the biopharma industry are “underappreciated.”
Johnson & Johnson will not appeal the dismissal of its bankruptcy proposal.
Nearly two dozen states on Tuesday sued the Department of Health and Human Services over a planned $11 billion funding cut for public health projects while New Jersey Senator Cory Booker spoke for 25 hours in protest of Trump administration policies.
Biopharma leaders react to the forced resignation of CBER Head Peter Marks as RFK Jr.’s promised job cuts begin at the FDA; Novo Nordisk presents mixed results from oral semaglutide in cardiovascular disease; the EU’s Committee for Medicinal Products for Human Use declines to recommend Eli Lilly’s Alzheimer’s drug; and pharma R&D returns grew in 2024.
Already reeling from years of market chaos, the announced departure of CBER chief Peter Marks sent a ripple across biopharma markets.
Organon’s workforce cuts come several months after the company’s loss of exclusivity to its second-largest product, Atozet.
The latest cuts, which are part of a larger reduction of 10,000 at the Department of Health and Human Services, were reportedly underway Tuesday, with CDER Office of New Drugs Director Peter Stein added to the list of casualties.
Cell therapy and oncology–focused Carisma Therapeutics started layoffs late last year. Now the company plans to wind down fully.