Drug Development
After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.
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Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
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It’s uncertain if the origins of COVID-19 will ever be determined, but the current top theories split about evenly between a lab leak from the Wuhan Institute of Virology and a natural evolution from bats to animals to humans at a Wuhan “wet market.”
The EUA request is based on the Phase II study that showed treatment with ensovibep reduced the viral load from the SARS-CoV-2 virus within eight days of use compared to placebo.
Merck has announced positive results from its Phase III KEYNOTE-522 study on the use of KEYTRUDA alongside chemotherapy in high-risk early-stage triple-negative breast cancer.
REGENXBIO presented results from its ongoing Phase I/II trial of RGX-111, an investigational one-time gene therapy for people with Mucopolysaccharidosis Type I (MPS I).
Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
Johnson & Johnson has temporarily paused production of its COVID-19 vaccine at its manufacturing site in The Netherlands.
A week after Novavax submitted its Emergency Use Authorization materials to the FDA for its COVID-19 vaccine candidate. reports are coming out about the company’s problems with the production and delivery.
The COVID-19 pandemic has seen a full-blown effort from biopharma and researchers to develop new drugs and test old ones against the disease, with highly mixed results.
enGene announced positive results from its LEGEND Phase I/II clinical trial for treating high-grade NMIBC in patients with carcinoma in situ that are unresponsive to BCG treatment.
Statistically significant weight loss and liver fat reduction were seen across all dosage groups—with no changes to diet or exercise.