News
AbbVie and Novartis strike billion-dollar pacts while attendees at the J.P. Morgan Healthcare Conference await that one big M&A deal and Merck teases limitless buying capacity; Eli Lilly readies for potential orforglipron launch while Novo Nordisk laments compounders; the IPO window cracks open; and the FDA concludes that GLP-1s do not pose a suicide risk.
FEATURED STORIES
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Heightened diligence standards and longer decision timelines for early-stage startups slowed venture activity last year, J.P. Morgan found in a report published ahead of the bank’s annual healthcare conference in San Francisco.
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
Rybelsus can now be used as a primary or secondary prevention pill to lower the risk of major adverse cardiovascular events in at-risk patients with type 2 diabetes.
Glaukos’ Epioxa allows cross-linking therapy for keratoconus without requiring an incision. The biotech expects to launch the drug early next year.
Recent headlines proclaim a ‘potential’ or ‘functional’ cure for multiple myeloma, but the fight against the disease must continue.
After a chaotic year that has seen the attrition of over half the FDA’s senior leadership, many of these individuals have landed new roles—at Eli Lilly, Pfizer, Iovance and more. The FDA’s loss, it seems, is largely the pharmaceutical industry’s gain.
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.
Roche will gain worldwide rights outside of the Greater China region to Hansoh’s HS-20110, an antibody-drug conjugate in early-stage development for colorectal cancer.
The Commissioner’s National Priority Voucher awards companies that align with specific national priorities—such as boosting domestic manufacturing and lowering drug prices—with faster reviews and more frequent interactions with the FDA.
With more than $1.5 billion on the line, Gilead looks to bolster its CAR T portfolio.
EMD Serono will offer its fertility treatments on TrumpRx at a steep discount, and Roche’s direct-to-consumer offering will cover its flu pill Xofluza.
In this episode presented by PII, BioSpace’s head of insights discusses decentralized clinical studies and how connected technology can improve patient compliance with guests Oliver Eden and Travis Webb.