AstraZeneca’s Calquence was cleared to treat newly diagnosed mantle cell lymphoma patients, while Amgen’s Lumakras and Vectibix combo can reach certain patients with KRAS G12C-mutated metastatic colorectal cancer. More: AstraZeneca's Calquence and Amgen's Lumakras clinch FDA label expansions Source: fierce
read moreThe roller-coaster ride for Novartis—as it uses every bit of its legal muscle to extend Entresto’s market exclusivity—took another zig on Thursday with a federal appellate court blocking the sale of a generic version of the heart failure blockbuster. More:
read moreAbout two and a half years after originating the role of chief commercial officer at Arvinas, John Northcott is leaving his post at the biotech. More: Arvinas’ inaugural commercial chief steps down, to be replaced in the interim by market
read moreIn the phase 3b STEP UP study, an experimental 7.2-mg semaglutide dose helped patients lose more weight on average at 72 weeks compared to placebo or semaglutide 2.4 mg, which is currently the highest dose of Novo Nordisk’s drug marketed
read moreThe U.S. government has selected the second batch of drugs up for Medicare price negotiations under the Inflation Reduction Act. The list of 15 medicines includes blockbuster drugs from Novo Nordisk, Pfizer, Bristol Myers Squibb, AstraZeneca, GSK and other companies.
read moreA government watchdog examining the FDA’s accelerated approval pathway has released a report concluding that the agency’s controversial endorsement of Biogen’s failed Alzheimer’s treatment Aduhelm was generally an outlier. But the OIG also suggested tweaks to the approval program. More:
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