Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Astrazeneca, Biocryst, Immunabs, Janssen, Jubilant, Panbela, Syros, Vaxcyte, Xortx.
Amylyx Pharmaceuticals Inc. got good news when the Institute for Clinical and Economic Review posted a revised evidence report Aug. 4 that assessed the comparative clinical effectiveness and value of the company’s AMX-0035 and Mitsubishi Tanabe Pharma America Inc.’s Radicava (edaravone) in treating amyotrophic lateral sclerosis.
No one denies that fewer new drugs will be a consequence of the Medicare drug pricing provisions the Democrats are trying to push through the U.S. Congress ahead of the midterm election campaign season. Less attention has been paid to the negative impact on drug-device combinations and new diagnostics that accompany innovative treatments.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acclarent, Endologix, Glaukos, Pulse Biosciences.
Makers of biotech therapies and in vitro diagnostics may be understandably weary of hearing about patent subject matter eligibility under Section 101 of the Patent Act, but Sen. Thom Tillis (R-N.C.) is prepared to take another swipe at the problem. Tillis announced Aug. 3 that the Patent Eligibility Restoration Act of 2022 is intended to reverse some of the deleterious effects of U.S. Supreme Court jurisprudence on Section 101 questions, a proposal that may be the last, best chance to address what many believe is a fundamentally broken judicial understanding of subject matter eligibility.
No one denies that fewer new drugs will be a consequence of the Medicare drug pricing provisions the Democrats are trying to push through the U.S. Congress ahead of the midterm election campaign season.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ICU, Smiths, Twist.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Calidi, Cellectis, Pfizer, Takeda.
The U.S. FDA’s breakthrough devices program has engendered a tremendous amount of interest on the part of industry, but an Aug. 2 report by the law practice of Epstein Becker & Green P.C., suggests that the value of the program may be overblown. The report states that only 44 of the more than 600 devices that have been granted access to the program have successfully emerged – a number that was updated Aug. 3 by the FDA to 54 – which is still a rate that suggests that the breakthrough devices program might not be as helpful as billed.
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