Policy
Along with CRISPR/Cas9-based Casgevy—developed by Vertex Pharmaceuticals and CRISPR Therapeutics—the regulator on Friday approved bluebird bio’s Lyfgenia, a second gene therapy for sickle cell disease.
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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 Pregnant Workers Fairness Act (PWFA) has been praised by many in the life sciences who see it as a step forward in protecting the rights of pregnant employees.
The FDA issued complete response letters to Phathom Pharmaceuticals, flagging the presence of N-nitroso-vonoprazan (NVP) impurities in its Helicobacter pylori drug products.
Vertex Pharmaceuticals is marching toward the launch of exa-cel with a lot of confidence, per its full-year 2022 presentation.
The FDA’s Oncologic Drugs Advisory Committee voted 8-5 that two single-arm trials would be “sufficient to characterize the benefits and risks” of Jemperli in locally advanced rectal cancer.
Trade secrets litigations and disputes have been on the rise in recent years, and given the FTC’s recent proposal to ban all non-compete agreements nationwide, the trend is likely to continue.
GSK has dropped two assets, an investigational celiac disease therapeutic and a Staphylococcus aureus vaccine hopeful, from its pipeline.
The FDA asked Taysha Gene Therapies to dose more patients in a double-blinded, placebo-controlled trial before submitting a BLA for its giant axonal neuropathy candidate.
As the 118th Congress kicks into gear, biopharma industry observers speculate that 2023 may be a challenging year.
Novartis’ SCD therapeutic Adakveo is under review by the EMA after failing to replicate previous efficacy results in a Phase III trial.
Sen. Elizabeth Warren (D-MA) voiced concerns to the FTC regarding the prospective acquisitions of Horizon Pharmaceuticals and Opiant Pharmaceuticals by Amgen and Indivior.