With rising rates of disease and established guidelines for treatment, officials at Lexicon Pharmaceuticals Inc. have “the wind at our backs” as they go about commercializing Inpefa (sotagliflozin) for heart failure (HF), after the drug was cleared late May 26 by the U.S. FDA, said CEO Lonnel Coats. Shares of The Woodlands, Texas-based Lexicon (NASDAQ:LXRX), which had risen significantly after hours on word of the Inpefa go-ahead, closed May 30 at $2.90, down 28 cents. Regulators gave their nod to the inhibitor of renal sodium-glucose co-transporter 2 (SGLT2) and intestinal SGLT1 with a broad label across the full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes. Read More
Pfizer Inc. has positive phase III data for its hemophilia treatment as it wades deeper into an indication that already has plenty of competition and at least one company with earnings of more than $1 billion. Pfizer’s marstacimab in treating hemophilia could lead to the first once-weekly subcutaneous treatment for hemophilia B and could end up being the first treatment administered as a flat dose for treating hemophilia A or B. Read More
In a deal potentially worth $392 million, C4 Therapeutics Inc. signed with Betta Pharmaceuticals Co. Ltd. to develop and market an orally bioavailable BiDAC degrader for non-small-cell lung cancer (NSCLC). Read More
Eli Lilly and Co. is paying $13.5 million to bow out of a class action lawsuit that claimed the list price of several insulin analogue products was fraudulent. Lilly also committed to capping the monthly patient out-of-pocket cost at $35 for its insulin products for at least four years, bringing the total value of the settlement, announced May 26, to more than $500 million, according to the attorneys who filed the class action on behalf of patients in 2017. Read More
Regenerative medicine product Stemchymal, an allogeneic adipose-derived mesenchymal stem cell treatment, missed the primary efficacy endpoints in two phase II spinocerebellar ataxia trials conducted in Japan and Korea, but a subpopulation analysis showed efficacy signals in patients with more severe conditions, Reprocell Inc. reported. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biophytis, Ferring, Genelux, Oxurion, Profoundbio, Structure, Theseus, TME, Xilio. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biophytis, BMS, Curium, Gilead, Hutchmed, Inventiva, Ipsen, Novavax, Novo Nordisk, Sino, Takeda. Read More
