Citing significant implications for patients with advanced Parkinson’s disease, as well as the broader public interest that’s at stake, the U.S. FTC filed an amicus brief in Sage Chemical Inc.’s district court challenge of Supernus Pharmaceuticals Inc.’s strategies to block generic competition of its injectable Parkinson’s drug, Apokyn (apomorphine).
As Medtronic plc. is fond of pointing out, the garage inventor has been the stuff of legend in U.S. business lore, providing a wide range of economically impactful inventions over the two-plus centuries since the U.S. patent system came into being.
Edwards Lifesciences Inc., has joined Apple Inc., and several tech companies in suing the U.S. Patent and Trademark Office (PTO) over PTO’s administration of the inter partes review (IPR) process in a lawsuit that reached the Court of Appeals for the Federal Circuit. The court recently rejected the challenge as to whether the PTO is empowered by the statute to determine whether an IPR could be instituted, but the agency may be forced to engage in the clunky rulemaking process to formally encode the so-called Fintiv standard for acceptance of IPRs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advamedica, Brainomix, Etiometry, Graymatters Health, Inspire Medical Systems, Viz.ai.
The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date, with as many as 420 trials expected to be delayed over the next three years, according to an EFPIA member survey.
While U.S. policymakers focus on drug prices, mandatory federal spending on Medicare and Medicaid for 2010 through 2020 was actually 9% lower than what the Congressional Budget Office (CBO) projected in 2010. One of the “significant sources” the CBO cited for its off-the-mark projection was less-than-anticipated spending for Medicare Part D prescription drugs due to new generic competition and fewer new brand drugs being launched. In light of reality, the CBO has lowered its long-term projection of health spending through 2033.
The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Aquavit, Arrowhead, Aviceda, Boan, Diamond, Enlivex, Fore, Ichnos, Intellia, Jiangsu Recbio, Luye, Mereo, Prestige, Sanofi, Sensei.
Device makers doing business in the EU finally have official word that the new implementation dates for the Medical Device Regulation (MDR) are in force, offering some vital breathing room for products already on the market. However, manufacturers that wish to obtain a new certificate for their legacy devices still have a lot of work to do as they must file at least a preliminary application for these devices with a notified body (NB) by May 26, 2024, not a mean feat given the crunch on notified bodies operating in the EU.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Asensus Surgical, Cue Health, Lunit, Surgvision.
RSS
