Policy
Even after the runaway success of mRNA vaccines against COVID-19, the pathway to approval for upcoming would-be mRNA therapeutics has yet to be laid out.
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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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Verve Therapeutics’ base editing program has been forced into a detour after the FDA placed a hold on its investigational new drug application. Beam has also posted its own regulatory update.
Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.
Sanofi and AstraZeneca won European approval for the first preventative RSV treatment for a broad population of newborns and infants.
The FDA is gearing up for deadlines and PDUFA dates in mid-November with Seagen, Provention, Clarus and Tolmar, and Ligand and Travere.
Apellis is submitting additional 24-month efficacy data to supplement the NDA for its intravitreal candidate pegcetacoplan for GA secondary to AMD.
Cassava filed a lawsuit in federal court against individuals linked to a Citizen’s Petition filed with the FDA that raised concerns about data manipulation in a clinical study of simufilam.
Abeona Therapeutics will head to the FDA next year for the potential approval of its experimental recessive dystrophic epidermolysis bullosa (RDEB) therapy following positive Phase III data.
GSK scored a pivotal Priority Review from the FDA for its RSV vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data.
Verge Genomics dosed its first patient in a Phase I trial studying VRG50635, while Stealth Bio’s SBT-272 was granted Orphan Drug designation by the FDA.
On Nov. 16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to discuss the relative merits of Ardelyx’s tenapanor in chronic kidney disease.