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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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A proposed class-action lawsuit accuses Johnson & Johnson of failing to negotiate fair prescription drug prices for its employees, but experts note that the company is also on the hook for benefits costs.
Takeda, AbbVie and Moderna are among the companies with open positions.
Jazz Pharmaceuticals is acquiring Redx Pharma’s KRAS inhibitor program including preclinical-stage drug candidates, with the companies working to advance assets through IND-enabling studies.
This week Lori, Greg and Tyler discuss drug pricing reforms. CMS sent offers to manufacturers of the 10 drugs that have been selected for Medicare price negotiations. What’s the best way forward that benefits patients while still supporting the innovation that makes these drugs possible? How will the election impact negotia
While analysts are bullish on Novo Holdings’ $16.5 billion acquisition of Catalent, they say it raises questions for companies that have contracted the CDMO for manufacturing.
Eli Lilly on Tuesday said it is already making manufacturing investments for orforglipron, its next-generation oral weight-loss candidate that recently moved into Phase III development.
Hit with lower sales of its COVID-19 antiviral Veklury and the weak performance of its HIV franchise, Gilead Sciences reported a 4% year-over-year revenue loss in the fourth quarter of 2023.
Thanks to a rough launch of its Biogen-partnered Alzheimer’s disease treatment, Eisai will likely miss its target of treating 10,000 patients with Leqembi by the end of March 2024.
With manufacturing issues persisting, last year’s shortages of medicines, including chemotherapies, weight-loss drugs and antibiotics, will continue into 2024.
Politics aside, both the government and the pharmaceutical industry want to bring affordable effective therapies to patients. Implementation is the obstacle. Working together is the only way to modify the IRA to do what it intends to do: benefit patients.