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Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been attached to approved CAR T cancer therapies reflects “thoughtful consideration of real-world evidence” and “regulatory trust.”
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President-elect Donald Trump and his incoming administration are unlikely to attempt a wholesale restructuring of U.S. healthcare and could promote M&A activity, but controversial picks like Robert F. Kennedy could impact vaccine sales, experts say.
Not exactly known for its dealmaking, Sarepta Therapeutics has thrown down a massive wad of cash to work with Arrowhead Pharmaceuticals on RNAi-based medicines.
Intra-Cellular submitted its application to the FDA for Caplyta’s approval in major depressive disorder, potentially opening up an additional $1 billion in sales. Still, the stock remains “cheap,” according to Jefferies analysts.
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Bayer and CrossBay Medical Inc., today announced a development and option to license agreement that will allow the development and production of a single-handed inserter to be combined with Bayer’s leading hormonal IUS portfolio.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and less affordable,” according to vaccine expert Paul Offit. It could also further complicate the picture for companies like Novavax.
Announcing first-quarter results, Biogen CEO Chris Viehbacher admitted that tariffs are “a new topic for us,” but said he does not expect major impacts—at least for 2025.
Global employee engagement fell two percentage points in 2024, according to Gallup, while BioSpace found that workforce sentiment decreased among biopharma professionals. Additionally, a recent BioSpace poll suggests engagement could continue to decline in 2025.
Jefferies analysts said Moderna’s first quarter was “in line,” with a miss on revenue offset by a beat on earnings per share.
According to CEO Daniel Vitt, clinical and disability-related outcomes are more relevant than brain volume change for drug development in multiple sclerosis.
To say, as CEO David Ricks did, that this was a good quarter, is an understatement. Mounjaro in diabetes brought in $3.84 billion for the quarter while Zepbound in weight loss booked $2.31 billion.
With Imaavy, J&J will go toe-to-toe with fellow Big Pharma AstraZeneca, which owns Soliris and Ultomiris.
The FDA has lost several senior employees in recent weeks, including some who have been at the agency for more than two decades.
When it comes to vaccination, the COVID-19 pandemic divided American society. President Donald Trump and his new Health and Human Services secretary are bringing down the hammer. What happens when there is no middle ground?
Many companies have foreshadowed deals to come during earnings calls in recent days. The return of M&A would be a welcome sign for the biopharma ecosystem, which has been battered by macro headwinds such as tariffs and the possibility of new drug pricing pressures.