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Eli Lilly Delays Donanemab Action Date as FDA Calls for Advisory Committee Review
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Eli Lilly (NYSE: LLY) has announced a delay in the action date for its Alzheimer’s disease candidate, donanemab, with the U.S. Food and Drug Administration (FDA) pushing the timeline beyond the fourth quarter of 2024. The delay follows the FDA’s request for an advisory committee meeting to evaluate donanemab’s Phase…
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China Cracks Down on Medical Insurance Fraud with New Guidelines and Increased Prosecutions
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China’s Supreme People’s Court, along with the Supreme People’s Procuratorate and the Ministry of Public Security, has issued new “Guiding Opinions Concerning Handling of Criminal Cases Related to Medical Insurance Fraud.” This initiative aims to strengthen the legal framework against fraudulent activities in the medical insurance sector. Under the new…
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FDA Approves Wegovy for Cardiovascular Risk Reduction in Obese Patients, First of Its Kind
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The U.S. Food and Drug Administration (FDA) granted an indication extension approval last week to Novo Nordisk (NYSE: NVO) for its GLP-1 receptor agonist Wegovy (semaglutide), allowing it to be used for the reduction of major adverse cardiovascular events (MACE) in overweight or obese adults with established cardiovascular disease (CVD).…
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Amgen Reports Positive Results for Otezla in Pediatric Psoriasis Trial
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Amgen (NASDAQ: AMGN) provided an update last week on a late-stage trial evaluating its PDE4 inhibitor Otezla (apremilast) for the treatment of moderate to severe plaque psoriasis in patients aged 6 to 17 years. The one-year data revealed that 56.3% of participants achieved clear or almost clear skin, while 71.4%…
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Merck’s 2023 Annual Report: A Mixed Bag Amid Global Challenges
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Merck KGaA (ETR: MRK), a leading German chemical, reported a 5.6% decline in its global net sales for the fiscal year 2023, amounting to €21.0 billion ($23.0 billion). This contraction was partially attributed to the adverse impact of foreign exchange rates. The company’s Healthcare division, however, posted a 2.7% increase…
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GSK Reports US Adult Non-Flu Vaccination Rates Recover Post-Pandemic
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GlaxoSmithKline (GSK; NYSE: GSK), a leading pharmaceutical company based in the UK, has reported that adult non-flu vaccination rates in the US have rebounded from the impact of the COVID-19 pandemic. According to data from GSK’s Vaccine Track platform, immunization rates between the first and third quarters of 2023 were…
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BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its anti-PD-1 drug Opdivo (nivolumab). The drug is now approved in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma (UC) in adults. The…
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BeiGene’s Brukinsa Receives FDA Approval for Relapsed or Refractory Follicular Lymphoma
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biotech company based in China, has announced its latest indication approval in the United States for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The US Food and Drug Administration (FDA) has granted approval for Brukinsa in combination with the…
