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Billions of dollars’ worth of cancer drugs are discarded each year. Manufacturers must refund Medicare for some of this waste. A data-driven approach offers a practical path to greater efficiency.
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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
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FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
FDA
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
THE LATEST
Kyverna Therapeutics, the fifth biotech with plans for an initial public offering this year, will use the proceeds to support the development of its anti-CD19 CAR-T therapies for autoimmune diseases.
The Centers for Medicare and Medicaid Services on Thursday sent its opening price proposals to drugmakers, which now have 30 days to either approve the offers or submit counteroffers.
Biotech companies are exploring multiple targets in the fight against neuroinflammation. Experts say these projects could yield the next breakthrough in treating Alzheimer’s disease.
The Swiss pharma on Thursday projected mid-single-digit sales growth for 2024, culling eight assets and looking to acquisitions and collaborations for de-risked assets with “significant potential.”
During a Wednesday webinar, FDA Commissioner Robert Califf said the agency is working on “systemic” changes to its advisory committee process.
Positive Phase III results for VX-548 could signal a new chapter in the fight against opioid addiction, but experts say there is still room to do better.
The first hearing on a potential injunction came the day before CMS is to release pricing proposals on 10 drugs.
Despite strong sales of its blockbuster drug Dupixent, Sanofi on Thursday reported that its fourth-quarter 2023 operating income dropped 5% due to a weaker U.S. dollar, high expenses and generic competition.
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.