Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Regent, Avadel, Bioinvent, Canbridge, Daiichi Sankyo, Foghorn, Hemogenyx, Innovent, Kyverna, Springworks, Theratechnologies.
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Astrazeneca, Amarin, Coherus, Edding, Enterin, Merck, Minoryx, Molecular Templates, Pfizer, TG, YS.
The U.S. House of Representatives has passed an agreement with the Biden administration on the debt ceiling, a deal that does not affect mandatory spending programs such as Medicare. However, the agreement, which still must gain the Senate’s stamp of approval, appears to eliminate any chance of yet more monies for the National Institutes of Health or the FDA, two programs of intense interest for companies in the life sciences.
With False Claims Act (FCA) whistle-blower lawsuits multiplying amid the complexity of regulations that often are unclear, the U.S. Supreme Court provided some clarity as to what constitutes a false claim in a unanimous opinion handed down June 1. But it’s not what the biopharma and med-tech industries were hoping for.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acticor, Aridis, Ascentage, Cocrystal, IGM, Pepgen, Pharmazz, Precigen, Rocket.
Becoming the second approved respiratory syncytial virus (RSV) vaccine for the 60 and older crowd, Pfizer Inc.’s Abrysvo (RSVpreF; PF-06928316) received a U.S. FDA nod on May 31 for RSV lower respiratory tract disease. In February, the agency’s Vaccines and Related Biological Products Advisory Committee voted 7-4 that data support both the safety and efficacy of the vaccine. Behind this approval for the senior population is another potential approval, expected in August, for infants via maternal inoculation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Amylyx, Beigene, Bristol Myers Squibb, Inhibrx, Iovance, Janssen, Lexicon, Metriopharm, SK, Valneva.
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.
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.
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