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Rep. Jake Auchincloss of Massachusetts said the Commissioner’s National Priority Voucher program did not receive congressional backing. The FDA has also not yet made disclosures for eight senior reviewers, according to Auchincloss.
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Analysts parsed the limited data available for Pfizer’s obesity candidate on the pharma’s fourth-quarter earnings call Tuesday, looking for any nugget of additional context.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
After suffering in the wake of expired tax incentives for pharmas, the island is trying to take advantage of geopolitics to grow its drug manufacturing sector.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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The trial demonstrated that C3G glomerulopathy patients treated with the oral factor B inhibitor saw a significant reduction in protein in their urine. The results come days after iptacopan won the FDA’s green light for a rare blood disease.
The company’s fiscal report for 2023 details revenue losses of $539 million and layoffs of 1,100 employees but notes that future GLP-1 manufacturing revenues could help stabilize its finances.
The New York-based pharma reported at ASH that odronextamab had an 80% objective response rate, with 73% of patients experiencing a complete response.
Patients treated with the investigational sickle cell therapy saw an increase in hemoglobin levels and improved red blood cell parameters.
The investigational allogeneic CAR-T therapy P-BCMA-ALLO1 appears to be more effective following strong immunosuppressive preconditioning.
Friday’s FDA approval of Vertex-CRISPR’s Casgevy and bluebird bio’s Lyfgenia has immediately revealed startling differences between these two gene therapies: price and a black-box warning.
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.
Another Flagship-founded company is shutting down its operations, according to an SEC filing. Axcella Health, which was focused on the development of a long COVID therapeutic, is no more.
Plexxikon, which was acquired by Daiichi Sankyo, and Novartis have agreed to settle a patent case involving the cancer drug Tafinlar and its sale in the U.S.
As Vertex and CRISPR Therapeutics’ exa-cel and Verve Therapeutics’ VERVE-101 move forward, questions remain about possible drawbacks of such therapies.