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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.
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
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Read our takes on the biggest stories happening in the industry.
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 biotech reported topline data from a mid-stage study of MM-120, its LSD-based drug, in patients with generalized anxiety disorder.
A European Medicine Agency panel on Friday reaffirmed its decision not to renew the conditional marketing authorization for GSK’s multiple myeloma drug Blenrep.
President Joe Biden has long promised to stand up to Big Pharma, lower prescription drug prices and limit the power of drugmakers—a pledge he seems intent on keeping.
FDA
Merck’s HIF-2α inhibitor Welireg has been approved by the FDA to treat advanced renal cell carcinoma after treatment with PD-1 or PD-L1 and VEGF-TKI-based therapies.
Despite pricing concerns for bluebird bio’s FDA-approved sickle cell disease gene therapy, the biotech has inked a deal with an unnamed commercial payer “representing approximately 100 million covered lives” in the U.S.
A week after securing FDA approval, a European Medicines Agency committee has endorsed Vertex and CRISPR Therapeutics’ Casgevy for sickle cell disease and transfusion‑dependent beta thalassemia.
Amid falling COVID-19 revenues, Pfizer continues to invest in antibody-drug conjugates in a deal with Nona Biosciences worth $1 billion as its $43 billion Seagen buy closed on Thursday.
The regulator placed the clinical hold on the Chinese biotech’s trio of CAR-T cell therapy candidates after an inspection of its Durham, North Carolina manufacturing facility.
FDA
Despite the lack of a randomized clinical trial to support eflornithine’s efficacy, the regulator approved US WorldMeds’ oral maintenance treatment for high-risk neuroblastoma in adults and children.
At the urging of the Biden administration, Sanofi and AstraZeneca are pledging 230,000 additional doses of their respiratory syncytial virus infant immunization Beyfortus in January 2024.