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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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
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The clinical hold doesn’t cover its drug’s Investigational New Drug application for autoimmune hepatitis, for which the Phase IIa PORTOLA trial is ongoing.
After several high-profile failures, including BMS’ $1.5B breakup with Agenus, anti-TIGIT therapies are generating cautious optimism.
After psychological side effects doomed the first generation of cannabinoid receptor 1–targeting drugs for weight loss, Novo Nordisk, Corbus Pharmaceuticals and Skye Bioscience are betting that a new mechanism of action will improve the safety profile.
Relay Therapeutics is cutting its workforce to help streamline its research organization as it looks to complete its first large-scale, pivotal clinical trial.
Scaling GLP-1 manufacturing capacity remains a key priority for the pharma industry, to help supply catch up with the insatiable demand for weight loss drugs.
Under the deal announced Friday, the Italian pharma will make an upfront payment of $825 million to Sanofi for global rights to a biologic for the treatment of cold agglutinin disease, with milestone payments of up to $250 million.
The company is lowering its previously issued guidance for 2024 adjusted earnings per share by $0.04 per share to account for acquired in-process research and development expenses incurred for acquisitions and collaborations in the third quarter.
Opdivo’s approval for patients with resectable non-small cell lung cancer comes as the regulator recently raised concerns of overtreatment with this type of therapeutic regimen with platinum-doublet chemotherapy.
While a JAMA study found a decline in mpox antibody responses after vaccination, a University of Oxford expert cautioned that there is still not enough evidence to determine if this decline also leads to waning protections.
Gilead Sciences is granting licenses to six companies to produce lenacapavir for pre-exposure prophylaxis, as well as for treating human immunodeficiency virus in heavily pre-treated adults with multidrug-resistant infections.