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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With the results from the CLEAR outcomes study, Esperion is poised for a major inflection in sales and is targeting blockbuster status, said CEO Sheldon Koenig on an investor call Monday.
Incyte Corporation’s Phase III LIMBER-304 clinical trial has come to an end following a third-party investigation that forecasted poor results.
Voyager Therapeutics unlocked a potential $600 million plus $25 million upfront as Novartis exercised its option to leverage the company’s capsids against two undisclosed neurologic disease targets.
Shares of Praxis Precision Medicines dropped 48% Friday morning following mixed Phase II results for ulixacaltamide (PRAX-944), its candidate being studied in movement disorder essential tremor.
Phase III data showed the combination of Roche’s Tecentriq and Exelixis’ Cabometyx fell short of its primary endpoint in renal cell carcinoma.
Eli Lilly is expanding its pain management pipeline with a new asset from Belgium-based Confo Therapeutics targeting the angiotensin II type 2 receptor.
Backed by Google Ventures, ARCH Venture Partners and more, Chroma Medicine announced the closing of a $135 million Series B financing Wednesday.
Phase III KEYNOTE-671 study data showed Merck’s Keytruda improved event-free survival, one of the trial’s primary endpoints, in patients with stage II, IIIA or IIIB non-small cell lung cancer.
Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.
Wednesday, the FDA’s VRBPAC agreed that GSK’s respiratory syncytial virus vaccine candidate is safe and effective in older adults.