Policy
Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA’s docket this quarter.
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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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Citing reports of “alarming toxicity” among other accusations, short-seller Scorpion Capital will file a Citizen’s Petition with the FDA to have its approval of Wakix withdrawn.
The FDA has granted an advisory committee meeting for BrainStorm Cell Therapeutics’ investigational ALS therapy, NurOwn, the company announced Monday.
The FDA is expected to make decisions on Emergent BioSolutions’ sNDA for OTC Narcan and Roche’s Polivy in frontline DLBCL.
Upstaza is the first targeted therapy for aromatic L-amino acid decarboxylase (AADC) deficiency. PTC expects to submit a Biologics License Application to the FDA in the first half of 2023.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that tofersen’s effect on neurofilament light chain (NfL) could be a reasonable predictor of clinical benefit.
Peter Marks described the steps the agency is taking to advance the development of gene therapies for rare disorders. This could spell good news in the near future for Sarepta Therapeutics.
Karuna Therapeutics released data Monday from the Phase III EMERGENT-3 trial showing that KarXT met the primary endpoint, significantly improving symptom severity.
An advisory committee will meet March 22 to discuss the fate of Biogen and Ionis’ ALS hopeful tofersen. For that and more, see inside.
Pfizer and Astellas announced positive topline Phase III results Thursday for Xtandi plus leuprolide in non-metastatic castration-sensitive prostate cancer.
The FDA will hold an advisory committee meeting for Sarepta’s investigational gene therapy for Duchenne muscular dystrophy ahead of its May 29, 2023 action date.