Drug Development
Shares of Akero Therapeutics took a hit after the company missed the primary endpoint in a Phase IIb study of efruxifermin in nonalcoholic steatohepatitis.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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TauRx announced preliminary results from the Phase III study, showing HMTM, its potent inhibitor of tau aggregates, could slow Alzheimer’s disease progression or cognitive decline.
Provention Bio entered a co-promotion agreement with Sanofi ahead of the possible November approval of teplizumab. If approved, the drug would be the first approved to modify T1D.
Adocia, Allecra Therapeutics and Aldeyra Therapeutics announced promising results in Type I Diabetes, urinary tract infections and retinal diseases.
While Biogen and Eisai’s recent lecanemab data breathed new life into the anti-amyloid approach, experts say combination therapies will likely play a significant role in treating Alzheimer’s disease.
GSK reported Wednesday its checkpoint inhibitor Jemperli yielded positive data in non-small cell lung cancer, moving the monoclonal antibody potentially closer to the market in this indication.
TrialSpark and Sanofi announced a new partnership to expedite drug development for areas with high unmet needs by licensing or acquiring six mid-to-late-stage drug candidates.
Araris Biotech AG secured $24 million in financing to advance the development of its proprietary antibody-drug conjugate (ADC)-linker technology and drive its own ADC candidates into the clinic.
Early data from the Phase III TALAPRO-2 study showed Talzenna, Pfizer’s oral PARP inhibitor, met its primary endpoint in metastatic castration-resistant prostate cancer patients.
KalVista Pharmaceuticals announced Tuesday that life-threatening safety concerns prompted it to shut down a mid-stage clinical trial for hereditary angioedema.
Synlogic, Senti Biosciences and Novome are pioneering the field of synthetic biotics, which is so new there are only a handful of scientific articles using either that term or ‘engineered living therapeutics.