News
Four of this year’s biggest acquisitions topped 11-figure figures. One was 2025’s messiest bidding war.
FEATURED STORIES
Of all the stories we published this year, these deep dives by BioSpace editors stand out as relevant re-reads going into the New Year.
The second half finished strong after two tumultuous years. What will 2026 bring for the biotech sector?
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
THE LATEST
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
Four Los Angeles County life sciences projects are receiving funding to support goals that include adding jobs, creating multitenant facilities for graduation-stage companies, financially supporting emerging businesses and attracting large employers to the area.
Suddenly one obesity asset has come to define Amgen but executives see a fuller portfolio that will bring the big biotech into the future.
Contingent value rights are rising in a down market, helping to close the gap between buyer and seller expectations in biotech transactions.
In a livestreamed meeting Tuesday afternoon, Health Secretary Robert F. Kennedy Jr. drew a dark portrait of the state of America’s health while addressing the MAHA Commission’s most recent report, which includes plans to research potential links between vaccines and rising rates of chronic disease.
Executives at Novartis have not been shy about a desire to buy more companies, with cardiovascular a big focus. In total, the Swiss pharma has put $17.23 billion on the line in M&A and licensing deals this year.
After receiving a complete response letter for its pyruvate dehydrogenase complex deficiency candidate, Saol Therapeutics anticipates it will need “several years” and “significant financial resources” to address the FDA’s concerns.
Truist Securities called pumitamig’s data on Monday “very reassuring,” given the consistency between its performance in Chinese and global patient populations.
Novartis has been investing heavily in its cardiovascular pipeline this year, forging partnerships with Flagship startup ProFound Therapeutics and China’s Argo Biopharmaceutical, among others.
Regeneron’s antibody duos significantly lowered eye itching and redness, as well as pin prick reactivity, in people with cat and birch allergies. Still, BMO Capital Markets expressed uncertainty about the assets’ “commercial potential in a highly generic market.”