Japan’s Ministry of Health, Labour and Welfare has given Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. the green light for its oral heat shock protein 90 (HSP90) inhibitor Jeselhy (pimitespib) to treat gastrointestinal stromal tumors (GIST) that have progressed after chemotherapy. The company will soon commercialize the drug in Japan.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Amryt, Argenx, Basilea, Biomarin, Croma, Cytokinetics, Daewoong, Emergent, Gilead, Janssen, Kyowa Kirin, Merck, Novartis, Novavax, Oncopeptides, Sarepta.
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.
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.
Novartis AG is not going quietly into the night after the U.S. Court of Appeals for the Federal Circuit reversed itself, invalidating a method patent covering a dosing regimen for the company’s blockbuster multiple sclerosis drug, Gilenya (fingolimod). After the split opinion came down June 21 from the three-judge panel, Novartis said it planned to file a petition seeking further review of the decision by the full court.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acer, Ardelyx, Beigene, Ceruvia, Eli Lilly, Eyepoint, Innovent, Medsenic, Midatech, Nuvectis, Ocumension, Phanes, Regulus, Relief, Tranquis, Xenon.
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