Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alx, Invivyd, Pharvaris.
In releasing a revised guidance June 30 detailing the requirements of the new Medicare Drug Price Negotiation Program, the U.S. Centers for Medicare & Medicaid Services addressed some of the issues raised in recent constitutional challenges to the guidance and the underlying negotiation provision in the Inflation Reduction Act.
The U.S. FDA is on a roll with new drug approvals for Pfizer Inc., clearing severe alopecia areata treatment Litfulo (ritlecitinib) just under a month after giving the go-ahead for the firm’s oral COVID-19 antiviral, Paxlovid (nirmatelvir/ritonavir).
The U.S. FTC picked up six allies in its unprecedented effort to stop Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc, as the attorneys general for California, Illinois, Minnesota, New York, Washington and Wisconsin joined the agency in signing onto an amended complaint filed under seal June 22 in the U.S. District Court for the Northern District of Illinois.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medical IP.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amylyx, Astrazeneca, Boehringer Ingelheim, Erasca, Gilead, Intercept, Janssen, Leo, Lianbio, Moderna, Molecure, Pfizer, Sarepta, Zealand.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atyr, Cidara, GSK, Kite, Kymera, Mindset.
Japan’s Pharmaceutical and Medical Devices Agency has cleared Healios K.K. and Sumitomo Pharma Co. Ltd. to begin a phase I/II study of HLCR-011, which is composed of retinal pigment epithelial (RPE) cells derived from allogeneic induced pluripotent stem cells (iPS) in patients with RPE tear.
Intercept Pharmaceuticals Inc.’s second attempt to score an expanded U.S. FDA approval of its farnesoid X receptor agonist, obeticholic acid, in patients with non-alcoholic steatohepatitis (NASH) went the way of the first, with the agency issuing another complete response letter (CRL), prompting the company to drop all NASH-related investment and cut a third of its workforce.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Imagebiopsy.
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