Far from eliminating the need for weight-loss procedures, glucagon-like peptide-1 receptor agonists could drive more people to seek them out. At least that’s what Fractyl Health Inc. and Bariendo Inc. hope, and they have strong evidence to support their case with a recent meta-analysis showing that individuals discontinuing the popular weight loss medications regain all their weight and more within two years.
U.S. Medicare coverage of telehealth and telemedicine sometimes seems to lag inappropriately, but fears of fraud were borne out in a conviction obtained recently by the Department of Justice.
The U.S. Federal Trade Commission said it sent letters to 37 contact lens prescribers reminding them a failure to automatically provide patients with a prescription can result in fines of more than $53,000 per violation.
The U.S. FDA gave Sarepta Therapeutics Inc.’s rAAVrh74 viral vector, used in an investigational gene therapy for the treatment of limb-girdle muscular dystrophy, a step up, making it one of the first platforms to receive the agency’s platform technology designation.
Moderna Inc. once again emerged the winner in a court skirmish over claims that its COVID-19 vaccine infringed two Alnylam Pharmaceuticals Inc. patents. The U.S. Court of Appeals for the Federal Circuit issued a precedential opinion May 4, agreeing with a federal district court in Delaware that Moderna didn’t infringe the patents. For both courts, the decision was based on a single issue of claim construction.
It’s a good week to be working on drugs targeting STAT6. Kymera Therapeutics Inc.’s, KT-621, the first oral STAT6 degrader candidate to enter the clinic, surpassed expectations with impressive safety, pharmacokinetic and biomarker data from a phase I trial, while potential fast-followers from Nurix Therapeutics Inc. and Recludix Pharma Inc. advanced via respective partnerships with Sanofi SA.
Epimab Biotherapeutics Inc. licensed out a development-ready KLK2/CD3 bispecific T-cell engager (TCE) for advanced prostate cancer to Juri Biosciences Inc. through a potential $210 million deal.
Vantive Health LLC, formerly the kidney care business of Baxter International Inc., plans to invest $1 billion over the next five years in development of digitally enabled dialysis products, innovation in acute organ support therapy options and expanding production capacity.
Epimab Biotherapeutics Inc. licensed out a development-ready KLK2/CD3 bispecific T-cell engager (TCE) for advanced prostate cancer to Juri Biosciences Inc. through a potential $210 million deal.
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
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