Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Calidi, Cellectis, Pfizer, Takeda.
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.
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.
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. “Stringent drug price controls have significantly hampered the competitive and innovative capacity of Japan’s biopharmaceutical industry in recent decades, serving as a warning for U.S. policymakers considering introducing Medicare Part D drug price controls in 2022,” according to the ITIF.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Immunitybio, Omeros, Shine.
Drug and device makers that offer health care professionals opportunities to earn continuing medical education (CME) points have a fine line to walk when sponsoring those programs, but a new advisory opinion by the Office of Inspector General (OIG) at the Department of Health and Human Services seems to draw a very clear line around those programs.
Sarepta Therapeutics Inc. said it plans to file a BLA for its gene therapy for Duchenne muscular dystrophy (DMD), SRP-9001, with the U.S. FDA, potentially setting up a decision in the first half of 2023 for the therapy developed in partnership with Switzerland’s Roche Holding AG. The Cambridge, Mass.-based biotech said the BLA will seek accelerated approval for the therapy, also known as delandistrogene moxeparvovec, for ambulant individuals with DMD.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Astria, Kira, Marinus, Quoin, Sareum, Step, Turning Point.
While the U.S. Senate Finance Committee is ostensibly investigating how big pharma is using the 2017 tax changes to avoid paying its fair share of U.S. taxes, at least one medical device company has been drawn into the probe and is being scolded for not cooperating.
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