News

FEATURED STORIES
After a $625 million IPO, the biggest ever in biotech, obesity-focused Kailera Therapeutics is readying a commercial strategy that puts patients at the center.
FDA
The FDA has expanded the regulatory toolkit during President Donald Trump’s second term, adding new mechanisms for rare diseases while putting the Biden-era platform technology designation into action.
FDA
As the FDA tries to clarify its intent for former FDA Commissioner Marty Makary’s plausible mechanism framework for bespoke therapies, experts emphasize the importance of expanding its scope to encompass rare diseases that affect more than just one or a few individuals.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
THE LATEST
Women and nonwhite racial/ethnic groups are still earning less in the life sciences. An industry consultant discusses the pay disparities, ways to fix the gaps and why change is needed.
Looking for a biopharma job in Illinois? Check out the BioSpace list of 11 companies hiring life sciences professionals like you.
While life sciences employment was down 0.3% nationally in 2024, it rose 1.9% in Washington, according to a new Life Science Washington report. The association’s CEO discusses the latest findings and how the state’s job market looks this year.
New Life told FDA inspectors that they lacked the authority to enter parts of a facility where it made the GLP-1 receptor agonists semaglutide and tirzepatide.
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
Finding the right people for critical open roles can be difficult even for biopharma leaders. In this column, Kaye/Bassman’s Michael Pietrack discusses four pitfalls executives face during the hiring process, starting with confusing scientific brilliance with leadership ability.
The pivotal study of zilganersen in Alexander disease missed a secondary endpoint, but analysts expect the FDA to approve the asset given the unmet need and overall data.
Eli Lilly and Rigel Pharmaceuticals partnered in February 2021 to advance a pair of RIPK1 blockers, but the pharma in October last year pulled the plug on one of these programs for central nervous system indications.
The deals keep rolling in, with Lilly penning a $7 billion pact for gene delivery biotech Kelonia Therapeutics and UCB taking over cell therapy-focused Neurona Therapeutics; President Trump signed a new executive order supporting the development of psychedelic therapies, sparking fanfare and concern alike; and the FDA’s recent Replimune decision has triggered broader debate about the agency’s flexibility.
Two of the biggest insurance providers have expressed reluctance to participate in the government’s BALANCE program that would have made GLP-1 drugs more affordable to patients.