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Pearce IP | Australia, European Union, India, etc. | 5 Jun 2023
BioBlast w/e 2 Jun 23
Novartis announced that the European Commission (EC) has approved its Cosentyx® (secukinumab) for a new indication to treat active moderate to severe…
Mintz | USA | 5 Jun 2023
FDA Requests Public Input on Increasing Access to Home-Use Health Technologies
The Center for Devices and Radiological Health (CDRH), the section of the Food and Drug Administration (FDA) responsible for the regulation of medical…
Katten Muchin Rosenman LLP | USA | 5 Jun 2023
New Medicare Coverage for Alzheimer's Disease Drugs
Centers for Medicare & Medicaid Services (CMS) recently announced that Medicare will cover drugs that could slow the progression of Alzheimer’s…
Pearce IP | Australia | 3 Jun 2023
Merck publishes new data on Keytruda® (pembrolizumab) in NSCLC and mesothelioma
Merck announced positive results in two studies evaluating Keytruda®, its anti-PD-1 therapy. Merck reported that its Phase 3 KEYNOTE-671 trial…
Reed Smith LLP | USA | 2 Jun 2023
Supreme Court Eliminates Appellate Procedure Trap for the Unwary
Dupree v. Younger, ___ S. Ct. ___, 2023 WL 3632755 (U.S. May 25, 2023), has nothing whatever to do with drugs, or devices, or product liability, but…
Sheppard Mullin Richter & Hampton LLP | USA | 2 Jun 2023
FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023
On May 22, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) issued an untitled letter to…
Knobbe Martens | USA | 2 Jun 2023
FDA Updates Cybersecurity Guidance
Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by…
Covington & Burling LLP | USA | 2 Jun 2023
FDA Shares Update on Food-Related PFAS Activities
On May 31, 2023, FDA shared a constituent update on its PFAS activities. The update explains FDA’s efforts to better understand PFAS in the general…
Shearman & Sterling LLP | USA | 1 Jun 2023
Second Circuit Affirms Dismissal Of Putative Class Action Against Pharmaceutical Company For Failure To Allege Misstatements and Scienter
On May 16, 2023, the United States Court of Appeals for the Second Circuit affirmed a district court’s dismissal of a putative class action asserting…
Brownstein Hyatt Farber Schreck LLP | USA | 31 May 2023
Breaking Down the Health Care Impact of the Fiscal Responsibility Act
The Fiscal Responsibility Act, the product of intense negotiations between the White House and House Republican leadership, suspends the debt limit…
