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.
Lepu Biopharma Co. Ltd. has been given conditional approval by China’s NMPA for its anti-PD-1 monoclonal antibody, Puyouheng (pucotenlimab injection), based on data from a phase II study. The drug was conditionally greenlighted for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors.
How many patents does it take to violate U.S. antitrust law? That question isn’t a lead-in to a lame joke. Neither is it a valid question for a patent challenge, according to the U.S. Court of Appeals for the Seventh Circuit, which Aug. 1 affirmed the dismissal of a payer suit against Abbvie Inc. that claimed the North Chicago drug company violated the Sherman Antitrust Act when it obtained 132 patents on Humira (adalimumab) and then invoked them against biosimilars.
Genuine Biotech Co. Ltd.’s azvudine has been granted conditional approval by China’s NMPA for the treatment of COVID-19. The drug, first granted conditional approval from the NMPA to treat HIV-1-infected adults with high viral loads in July 2021, is the first domestically developed oral medicine approved to treat COVID-19 in China and was approved just 10 days after its application was submitted on July 15.
As Democrats in the U.S. Senate rush to pass prescription drug pricing reforms through the reconciliation process this week, the nonpartisan Information Technology & Innovation Foundation (ITIF) is offering Japan’s experience with government price controls as a cautionary tale.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alx, Arcutis, Armata, Beam, Biosight, Celyad, Eccogene, Eledon, Gamida, Janssen, Krystal, Pharming, Scynexis, Veru, Zenas.
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