Government
The agreement will also secure a $150 price for future weight loss pills from Novo Nordisk and Eli Lilly—at least initially.
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
Nearly one-third of biotech and pharma professionals are thinking about leaving the U.S. to find biopharma jobs, according to a BioSpace LinkedIn poll. Career coaches discuss why people are considering relocating and what they should do before heading for the exit.
Generic versions of biologic drugs could hit the market without human trials and allow the market forces to bring down costs, HHS leaders said while announcing new draft guidance.
As third-quarter earnings continue to roll out, Novartis makes headlines with the second biggest acquisition of the year; Novartis’ CEO also downplayed the impact of Big Pharma pricing deals with the Trump administration; Regeneron continued the trend of dropping cell therapy assets; BioSpace takes a look at how the FDA is functioning mid-shutdown.
While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.
The coming flu season is the clearest indication yet that biopharma’s long-standing assumptions about predictability, prevention and portfolio structure are no longer guaranteed.
While the threat of tariffs dies down for the pharma industry, President Donald Trump is reportedly weighing a new investigation that could result in import taxes against U.S. trading partners that don’t pay enough for drugs.
Novo Nordisk’s leadership gets another shake-up as President Trump promises to significantly slash prices for its GLP-1 drugs; Summit/Akeso, Exelixis and more present new data at ESMO 2025; Replimune pops as FDA accepts resubmitted BLA; FDA names first winners of Commissioner’s National Priority Voucher program; and more.
CMS Administrator Mehmet Oz clarified that a deal has not yet been sealed with the manufacturer of semaglutide, Novo Nordisk, or any other GLP-1 drugmaker.
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