The EU’s Medical Device Coordination Group (MDCG) has advised the device industry that many manufacturers seem ill prepared for the transition to the Medical Device Regulation (MDR), which will be fully in force for all devices as of May 2024. MDCG said that that any leniency shown after that date will be granted only for devices that address an urgent public health need, potentially leaving many existing authorizations out in the cold.
Developers of artificial intelligence (AI) and machine learning (ML) algorithms in medical radiology tend to think of regulatory approval as the primary hurdle to market, but there is also the question of how to pay for the use of these products. Public and private payers obviously hold the purse strings, but appealing to payers is still not always as straightforward proposition as some would like, reinforcing the notion that coverage and reimbursement still combine to serve as one of the highest hurdles to market for AI and ML.
Winding down its current term, the U.S. Supreme Court on June 13 declined to hear appeals filed by Insys Therapeutics Inc. founder John Kapoor and former regional sales director Sunrise Lee.
A lot of eyes are on the World Trade Organization (WTO) Ministerial Conference taking place in Geneva June 12-15, as member countries try to reach a consensus on a proposal that would allow certain members to waive intellectual property (IP) rights on COVID-19 vaccines for at least three to five years.
Everest Medicines Ltd. has picked up its first marketing approval in China for Trodelvy (sacituzumab govitecan), a medicine licensed from Gilead Sciences Inc. It was approved to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Earlitec, Ekso, Lensar, Rune, Si-Bone.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Beigene, Cybin, Everest, J Ints.
Health Canada approved a device which Wayne, Pa.-based Teleflex Inc. described as the first commercially available biomechanical vascular device designed to close large holes in the femoral artery during endovascular catheterization procedures.
After surprising Wall Street by unanimously voting in favor of the gene therapy elivaldogene autotemcel (eli-cel) for early active cerebral adrenoleukodystrophy from Bluebird Bio Inc., the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee met again June 10, this time to examine the risk-benefit profile of the company’s betibeglogene autotemcel (beti-cel) for people with transfusion-dependent beta-thalassemia.
The EMA has a list and it’ll be checking it frequently to avoid shortages with the help of COVID-19 marketing authorization holders and EU members states.
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