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FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
Job Trends
Follow along as BioSpace tracks job cuts and restructuring initiatives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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Following in the footsteps of Novartis, J&J and Merck, GSK jumped into the J.P. Morgan dealmaking frenzy Tuesday, picking up respiratory and inflammation-focused Aiolos Bio.
Vertex still has an ongoing diabetes partnership with CRISPR, which gives it a non-exclusive license to the latter’s platform to develop a potential cure for type 1 diabetes.
Following the FDA’s approval of the program, PhRMA is once again suing to block Florida from importing prescription drugs from Canada.
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from JPM2024.
From the rising trend of royalty financing to other adaptive funding strategies, firms think outside the box in responding to unprecedented challenges.
Harpoon has several antibodies in its pipeline that are engineered to redirect a patient’s T cells to recognize and kill cancer cells.
The pharmaceutical giant will pay $28 a share to acquire Ambrx’s pipeline of ADCs, particularly its lead candidate for prostate cancer.
The Inflation Reduction Act, “march-in rights” to take back patents and M&A were among the issues discussed at a Sunday panel in San Francisco ahead of Monday’s start of the J.P. Morgan conference.
A day after inking an AI deal with Alphabet’s Isomorphic Labs, Novartis is back at it, acquiring Calypso Biotech and tying up with Shanghai Argo in two RNA-i-focused pacts.
Brand pharmas not only leverage ancillary patents but sometimes hide or misrepresent information to the U.S. patent office in order to extend market exclusivity and high prices.