Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Biological Laboratories, Amg International, Choicespine, Guard Medical, Ihealthscreen, Jenavalve, Quidel, Unity HA, Uroviu.
The Institute for Clinical and Economic Review (ICER) will turn its magnifying glass on insurance companies as it evaluates how 15 of the largest U.S. payers cover 28 cost-effective prescription drugs.
Global regulatory activity in 2021 has risen by 25% over this time last year, but the proportion of the activity associated with COVID-19 has dropped in recent months.
Two weeks after Pfizer Inc.-Biontech SE’s mRNA-based COVID-19 vaccine received emergency use authorization (EUA) for adolescents ages 12 to 15, the first in that age group, Moderna Inc.’s mRNA vaccine has hit the primary immunogenicity endpoint in its phase II/III study of participants ages 12 through 17.
Provention Bio Inc.’s diabetes candidate, teplizumab, is heading into a May 27 advisory committee meeting with a skinnier label than originally planned, which could signal a smoother path to approval. The positive briefing document the FDA put out Tuesday also suggested an approval path for what could be the first disease-modifying treatment available for type 1 diabetes (T1D).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acer, Ascletis, Asklepios, Idorsia, Janssen, Optimus, Pharmather, Provention, Sandoz, Scholar Rock, TG, Therapeuticsmd, TLC.
The impact of MRI procedures on medical devices has been the subject of regulatory concern for better than a decade, but the FDA needed until 2019 to craft a guidance that deals with testing and labeling for such considerations. The final guidance offers several tweaks and adjustments to the 2019 draft, but ignores several requests made by industry, including a request that the final not rely on a clinically relevant worst-case scenario when evaluating the potential for device heating.
LONDON – Wise Srl has received CE marking for its cortical strip electrode, validating the underlying flexible electronics technology and opening the door to the development of implantable devices for long-term neurostimulation.
In seeming opposition to U.S. Trade Representative Katherine Tai’s support of a proposed compulsory World Trade Organization intellectual property (IP) waiver on COVID-19-related medical products, U.S. Vice President Kamala Harris signed onto the G20’s May 21 Rome Declaration that commits the member countries to work to defeat the pandemic within the current flexibilities of the TRIPS agreement by promoting voluntary IP licensing agreements, technology and knowledge transfers, and patent pooling on mutually agreed terms.