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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Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
In its financial results for 2021, Takeda announced that it has decided to discontinue the development of TAK-609, a therapeutic for Hunter Syndrome.
The FDA has given approval for the commercialization of Eli Lilly and Company and Incyte’s Olumiant, setting a precedent for upcoming COVID-19 treatments.
Jacqueline Shea will take over as the new CEO and announced plans to discontinue its Phase III Innovate trial to prioritize its heterologous booster strategy for COVID-19.
AstraZeneca and Sanofi’s Phase-III and Phase-IIb clinical trials investigating the efficacy of nirsevimab shows 79.5% efficacy in the prevention of lower respiratory tract infections.
Genentech (Roche) reported Wednesday that its Phase III SKYSCRAPER-01 trial failed to meet its co-primary endpoint of progression-free survival (PFS).
ICER recommended two out of three outpatient treatments for COVID-19 in today’s market, singling out molnupiravir as having inadequate evidence that it is better than symptomatic care.
Cortexyme has entered into a deal to acquire Novosteo. Once the deal is finalized, the companies will enter the rare disease space and operate under the name Quince Therapeutics.
Current COVID-19 booster shots have a problem: they last only about four months and appear to have limited efficacy in a vaccinated population. Clearly, a more durable approach is needed.
Despite posting its first profitable quarter as a commercial stage company, shares of Novavax plunged 20% in Tuesday trading due to the slower-than-expected rollout of its COVID-19 vaccine.