Drug Development

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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
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Roche’s tiragolumab, when combined with its PD-L1 blocker Tecentriq, did not significantly improve progression-free and overall survival versus Keytruda and chemotherapy in patients with non-small cell lung cancer.
Eli Lilly, Rivus Pharmaceuticals and more target different biological processes in hopes of generating higher-quality weight loss and avoiding metabolic issues.
Two CRLs from the FDA last week cited concerns with third-party manufacturers, while Indian CDMOs may make a bid for U.S. business if there is a decoupling from Chinese companies under the BIOSECURE Act.
Johnson & Johnson and Legend Biotech’s Carvykti cell therapy significantly improved survival in patients with multiple myeloma when used in the second-line setting, the companies announced on Tuesday.
Taysha Gene Therapies looks to move past its pipeline culls and staff reductions by moving its lead asset into a possible billion-dollar market.
FDA
Donanemab, which will be marketed as Kisunla, will compete with Biogen and Eisai’s Leqembi.
DEI
This week on Denatured, Head of Insights Lori Ellis and guests discuss the implications of not addressing the DE&I data gaps for the future.
Cartesian Therapeutics’ mRNA CAR-T therapy met its primary endpoint in a mid-stage trial for the chronic autoimmune disorder and expects to raise $130 million via private placement equity financing.
In 2023, the ADC market exceeded $10 billion, and this momentum is persisting into 2024, as evidenced by several strategic deals and a robust pipeline of candidate drugs.
In a potential challenge to Pfizer’s Prevnar 20, Merck’s Capvaxive has been recommended by the Centers for Disease Control and Protection for use in preventing invasive pneumococcal disease in adults.