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Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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Buoyed by its strong performance outside of the U.S. market, Daiichi Sankyo on Wednesday again raised its sales expectations for the blockbuster antibody-drug conjugate.
The Inflation Reduction Act’s Drug Price Negotiation Program will erode only a small portion of global biopharma revenues and is unlikely to cause significant cuts to research and development, find researchers.
Driven by soaring demand for its diabetes and weight loss drugs, Novo Nordisk on Wednesday reported better-than-expected full-year 2023 earnings with a 31% sales increase.
The new FDA-approved manufacturing process for Kite’s CAR-T cell therapy Yescarta will allow a 14-day turnaround compared to 16 days, the company announced on Tuesday.
The investment in Illinois-based Cour Pharmaceuticals had participation from Bristol Myers Squibb, Pfizer Breakthrough Growth Initiatives and Roche Ventures.
Lori, Greg and Tyler discuss last week’s call for a class-wide box warning on all commercial CAR T therapies, while investigations are ongoing into cases of secondary malignancies. How do we approach this balancing act of treatment and side effects?
The Swiss pharma’s fourth-quarter sales fell short of analysts’ estimates on Wednesday, as the company said it dropped a late-stage blood cancer hopeful after failing a Phase III study.
The Centers for Medicare and Medicaid Services will enter talks with manufacturers to come up with a pricing and rebate scheme that will tie the gene therapies’ cost with their effectiveness.
Defender Pharmaceuticals on Tuesday did not reveal the reasons for the regulator’s rejection of its nasal gel version of scopolamine. The company is seeking a meeting with the FDA to “understand the issues.”
Here are the top companies on BioSpace with internship opportunities for graduate students.