Policy
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two rare diseases: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
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Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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The FDA has granted Priority Review for AstraZeneca and Daiichi Sankyo’s supplemental BLA for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors.
The Centers for Medicare and Medicaid Services’ initial proposed drug price cuts, due to pharma companies by Thursday under the Inflation Reduction Act, could range from 25% to 60%, analysts told Reuters.
The CEOs of J&J and Merck have finally committed to testifying before the Senate health committee regarding the high prices of drugs in the U.S. The hearing is set for Feb. 8.
The FDA’s myriad acronyms—and the differences between them—can be perplexing. BioSpace looks at the unique advantages of certain regulatory classifications for drug developers.
While the FDA continues to investigate reported cases of T cell malignancies in patients who received CAR-T therapies, the cause of the secondary cancers remains unclear.
Ahead of a Jan. 31 vote, Senate health committee chair Sen. Bernie Sanders on Thursday said he has the votes needed to subpoena the CEOs of Johnson & Johnson and Merck to testify on drug pricing.
After missing its Jan. 24 PDUFA date, the regulator has extended its review period but has not issued a new decision timeframe or requested additional data, Liquidia announced Thursday.
More than 3,000 people in the U.S. suffered from side effects of Ozempic in 2023, according to exclusive reporting on Wednesday from Reuters citing data from America’s Poison Centers.
The FDA’s Peter Marks and Nicole Verdun in the NEJM Wednesday disclosed that more than 27,000 CAR-T doses have been administered in the U.S. as of the end of 2023, of which there are 22 cases of T-cell cancers.
While the FDA considers a T cell malignancy risk to be applicable to all commercial CAR-T therapies, Gilead Sciences’ Tecartus has a revised warning that potential adverse events “may” occur.