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Vertex Pharmaceuticals has forged a partnership with Obsidian Therapeutics to develop new gene therapies based on the control of protein expression by cells. Read More
Speaker Nancy Pelosi (D-Calif.) announced the reintroduction of the House Democrats’ flagship drug pricing legislation, H.R. 3, on Thursday, signaling their intention to fight for its inclusion in President Biden’s next spending package. Read More
The FDA is reviewing significantly higher numbers of generic drugs under its Competitive Generic Therapy (CGT) pathway, the latest quarterly report on the agency’s GDUFA II performance reveals. Read More
The FDA has granted accelerated approval to GlaxoSmithKline’s monoclonal antibody Jemperli (dostarlimab) for treating women with recurrent or advanced endometrial cancer. Read More
Six hospital and pharmacy groups have submitted a letter to HHS Secretary Xavier Becerra objecting to drugmakers eliminating 340B drug discounts to contract pharmacies and calling on the department to take a more aggressive stance against such actions, including civil fines. Read More
The EU has made clear that it will set its sights on obtaining additional doses of Pfizer/BioNTech’s and Moderna’s mRNA-based COVID-19 vaccines, opting to pass on pursuing more doses of AstraZeneca (AZ)’s adenoviral-vector vaccine. Read More
The FDA’s latest quarterly snapshot of the agency’s GDUFA II performance shows fewer abbreviated new drug applications (ANDAs) under review than for the same time last year and that the agency is taking much longer to issue tentative approvals. Read More
Syndax Pharmaceuticals announced that its targeted cancer therapy, SNDX-5613, induced complete remission for certain advanced leukemia patients in an early-stage study. Read More