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The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its investigational COVID-19 vaccine.
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A recent study estimated that Wegovy’s label expansion beyond obesity could push Medicare spending to $145 billion annually, but analysts remain dubious of the estimate.
The next generation of Alzheimer’s therapeutics is moving away from amyloid plaques and tau tangles, offering multiple approaches to slow cognitive decline.
Bispecific antibodies and anti-TIGIT therapies both appear to be writing comeback stories as cancer experts head to Barcelona for the 2024 European Society for Medical Oncology Congress. Radioligand therapies and synthetic lethality assets are also attracting attention.
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Gilead Sciences, Inc. and Arcus Biosciences, Inc. announced that domvanalimab plus zimberelimab and chemotherapy showed encouraging overall response rate and six-month progression-free survival rate results in a preliminary analysis from Arm A1 of the EDGE-Gastric study.
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Read our takes on the biggest stories happening in the industry.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
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2023 marked the most bankruptcies in biopharma in more than a decade, with 14 companies filing for Chapter 11 protection. The number remained high in 2024.
A cautionary tale illustrates how forging a deal with a Big Pharma can have unexpected and far-reaching tax consequences.
The news comes on the heels of promising Phase I/Ib data, which point to the potential of casdatifan as a more effective alternative to Merck’s Welireg in renal cell carcinoma.
Executive coaches can help executives take their game to the next level in four key ways, from improving their self-awareness to reshaping their thinking.
Exelixis’ next-generation tyrosine kinase inhibitor zanzalintinib is being tested for colorectal cancer, renal cell carcinoma and head-and-neck cancer, with several readouts slated for the second half of 2025.
Recently appointed HHS Secretary Robert F. Kennedy Jr. in 2018 helped bring several cases against vaccine maker Merck, alleging injury linked to its HPV shot Gardasil.
Merck’s Keytruda may be the most talked about drug facing loss of exclusivity but it’s far from the only one, as several of the industry’s top-performers are losing key market protections. Some companies are more prepared than others.
Elisa Cascade, CPO at Advarra explains why addressing the challenges faced by clinical research sites is vital for improving patient trust and the overall viability of clinical trials.
The FDA is mired in uncertainty with some staffers losing their jobs over the weekend and more potentially to come, vaccines and psychedelic therapies could be facing very different futures under newly confirmed HHS Secretary Robert F. Kennedy, Jr., Moderna continues its downward revenue slide and Merck, Regeneron, BMS and more face strong patent headwinds.
The partnership splits the rights to Stoke’s epilepsy antisense oligonucleotide, with up to $385 million in potential payments due to Stoke.