News

FDA
The search continues for a new leader for the FDA’s Center for Drug Evaluation and Research after George Tidmarsh resigned on Sunday. Deputy Director Mike Davis is in the running, along with Mary Thanh Hai, currently head of the Office of New Drugs.
FEATURED STORIES
The company cut back in areas while investing in internal and external opportunities to offset the loss of exclusivity on a product that until recently accounted for 20% of innovative medicine sales.
To tailor cancer therapies to individual patients, Moderna, BioNTech and other companies are rethinking how they optimize manufacturing schedules and resources.
Recent headlines proclaim a ‘potential’ or ‘functional’ cure for multiple myeloma, but the fight against the disease must continue.
Job Trends
The number of employees laid off increased year over year during the first quarter. BioSpace recaps the five largest rounds of layoffs, which included BMS and Novartis cuts.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Less than a day into his second term, President Donald Trump ordered a freeze on communications at major public health agencies, among other moves that have sent waves through the biopharma industry.
THE LATEST
Pfizer has filed two separate lawsuits in an effort to stop Novo Nordisk’s unsolicited bid to acquire obesity biotech Metsera.
Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to outline his office’s thinking on accelerating gene editing reviews.
Novo Nordisk, under new CEO Maziar Mike Doustdar, has a new attitude. It’s making Pfizer livid.
Skyrizi and Rinvoq made nearly $7 billion combined, almost half of the company’s income for the quarter alone.
Otsuka Pharmaceuticals could shell out over $400 million in total for the Asia-Pacific rights to 4D-150, which combines a VEGF-C inhibitory RNAi with Regeneron’s Eylea into a single ocular injection.
Before being discontinued, the P2X7 receptor blocker had cleared a master protocol study in chronic pain, though Eli Lilly said that results were not sufficient for advancement of the Asahi Kasei–partnered asset.
Gilead is actively looking for late-stage and de-risked assets for potential deals across various therapeutic spaces, including liver disease, cancer and immunology.
IPO
With the shutdown ongoing, Evommune plans to close its IPO on Nov. 5 via a Securities Act clause that allows registrations to come into effect after a certain window has passed.
Ensho Therapeutics CEO Neena Bitritto-Garg, recently named to BioSpace’s 40 Under 40, proved her mettle managing one of the toughest partnerships out there: the one between Eisai and Biogen that led to new Alzheimer’s drugs Aduhelm and Leqembi.
CEO David Ricks wants Eli Lilly’s upcoming obesity pill to be accessible to patients who need it, but the company still needs to pay for the next generation of obesity medicines to come after that.