News
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
FEATURED STORIES
The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
The layoffs will take place throughout 2025 and will mostly affect Tenaya’s research and manufacturing operations. The company is continuing to test its hypertrophic cardiomyopathy gene therapy.
Despite a $400 million impairment charge, analysts say the removal of a drug-device combo from its portfolio is not a huge loss for Vertex given that the company has a more advanced type 1 diabetes candidate in zimislecel.
The stock market—and biotech insiders—reacted negatively to the allegedly forced resignation of CBER Director Peter Marks, who said RFK Jr. does not seek “truth and transparency” but rather “subservient confirmation of his misinformation and lies.”
Unlike other hemophilia therapies, Qfitlia is indicated for both hemophilia A and B, and can be given in patients regardless of the presence of neutralizing antibodies against clotting factor VIII or IX.
BMO Capital Markets analysts said the results potentially position lepodisiran as “one of the most durable assets in development to date” in the competitive Lp(a) space, where drugs are designed to lower the risk of cardiovascular events such as heart attack and stroke.
Ayrmid’s offer is 50% higher than bluebird’s previously announced deal with Carlyle and SK Capital Partners.
According to BMO Capital Markets, Rybelsus’ outcomes in SOUL were “inconsistent,” failing to significantly lower cardiovascular death and nonfatal stroke.
Werner held roles at Bristol Myers Squibb, AstraZeneca and Novartis before landing at Alltrna, where she works to develop tRNA-based treatments for a range of diseases.
In the coming two weeks, the FDA is expected to announce three big decisions, including one for a dry eye disease therapy.
While Novartis and Bayer got there first, AstraZeneca, Bristol Myers Squibb and Eli Lilly are all vying to bring their radiopharmaceutical assets to a market projected to be worth over $13 billion by 2033.