Sarepta Therapeutics Inc. aims to resolve “very quickly” the clinical hold placed by the U.S. FDA on SRP-5051 (vesleteplirsen) for Duchenne muscular dystrophy (DMD), said Louise Rodino-Klapac, chief scientific officer.
The first gene therapy to treat severe hemophilia A was among the drugs recommended for European approval by regulators from the EMA’s CHMP at its monthly meeting. Manufactured by Biomarin Pharmaceutical Inc., Roctavian (valoctocogene roxaparvovec) was recommended for conditional marketing authorization in the EU for severe hemophilia A in adults who do not have factor VIII inhibitors and no antibodies to adeno-associated virus serotype 5.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alterity, Amryt, Astrazeneca, Biontech, CNS, Fusion, Menarini, Merck & Co., Novartis, Novavax, Radius, Realta, Rockwell, Valneva.
The U.S. Department of Justice (DOJ) reported an indictment of a physician in Paducah, Kentucky for causing the filing of false claims to the Medicare program with the help of telehealth. The physician is liable for only $560,000 in penalties, but the announcement again underscores the department’s crackdown on telehealth fraud, regardless of the dollar value of the fraud.
Davita Inc., lost a U.S. Supreme Court ruling regarding limits to the private payer coverage for outpatient dialysis services despite, a development that took a double-digit bite out of Davita’s shares. However, shares of competitor Fresenius also took a hit, suggesting that the market sees the decision as a major setback for both companies.
It’s been a decade since the America Invents Act (AIA) transformed the U.S. patent landscape from a first-to-invent to a first-inventor-to-file system and added new contours with the creation of the Patent Trial and Appeal Board (PTAB) to hear post-grant patent challenges outside of court. While the AIA’s inter partes review process and other post-grant procedures have helped weed out weak patents, they’ve also increased the uncertainty and unpredictability of many patents. Now, 10 years on, Congress is assessing how the PTAB has developed in real life and considering what course corrections may be needed.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biomarin, Daiichi, Ellipses, Hoth, Ikena, Krystal, Merck & Co., Mustang, Novartis, Paratek, VBI.
The U.S. FDA reported a class I recall for a single lot of the Safestar 55 breathing filter system by Draeger Inc., due to partial obstruction of the filter, which can lead to hypoxia. The affected units were part of a lot that was to be destroyed, but were instead inadvertently distributed even though they were identified as unusable after a manual inspection process at Draeger.
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