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.
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye.
While the World Trade Organization (WTO) is taking a victory lap for getting a five-year intellectual property (IP) waiver across the finish line for COVID-19 vaccines, the accomplishment is being panned by spectators on both sides of the track.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Acepodia, BMS, Eli Lilly, Hepion, Moderna.
The U.S. FTC isn’t waiting to complete its investigation into potentially anticompetitive practices of pharmacy benefit managers to crack down on some of those schemes.
RSS
