Pfizer Inc. reported on Aug. 30, 2021, that its JAK inhibitor, abrocitinib, beat Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) in a head-to-head study of patients with moderate to severe atopic dermatitis. In the JADE DARE study, a higher percentage of patients taking abrocitinib had a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline to week two compared to Dupixent.
Higher antibody titer levels were found in participants receiving two doses of Moderna Inc.’s COVID-19 vaccine compared to those receiving the Pfizer Inc.-Biontech SE vaccine, according to a research letter published in JAMA.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaccine, Anixa, Diffusion, Epygenix, Inovio, Junshi, Lantern, Octapharma, Polaryx, Poseida, Therapeutic Solutions, UCB.
The CDC’s Advisory Committee on Immunization Practices (ACIP) heard a safety update on COVID-19 vaccines, took up the matter of booster shots, and voted on whether to recommend the vaccine from Pfizer Inc. and Biontech SE for people 16 and older, now that it’s fully licensed. Under an emergency use authorization, the vaccine can be given to people 12-15 years old.
Sure H.R. 3 could save the U.S. government hundreds of billions of dollars on drug spending, but that savings comes at a long-term cost in innovation that’s higher than the Congressional Budget Office (CBO) initially forecast.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biomarin, Enzene, Incyte, Junshi, Laekna, Morphosys, Pendopharm, Roche.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Ascendis, Astrazeneca, Biocryst, Biontech, Exelixis, Ironwood, Marinus, Merck, Ono, Pfizer, Scancell, Servier, Sesen, Takeda, Vertex, Zogenix.
Kite Pharma Inc. is no longer on the hook for $1.2 billion in damages and royalties a jury awarded to Juno Therapeutics Inc. and the Sloan Kettering Institute for Cancer Research in a patent infringement suit involving Kite’s CAR T therapy Yescarta (axicabtagene ciloleucel).
In a passionately worded 141-page decision, the U.S. Court of Appeals for the First Circuit said the lower court was wrong in overturning part of a jury verdict convicting former Insys Therapeutics Inc. executives of a scheme to bribe doctors to prescribe Subsys (fentanyl), which was approved only to treat breakthrough cancer pain.
Samsung Bioepis Co. Ltd. has emerged as the first company to obtain marketing authorization from the EMA for a biosimilar of Lucentis (ranibizumab), a significant development for the Korean biosimilar specialist. The approval comes less than two months after the company received a positive opinion from the EMA’s CHMP for Byooviz (ranibizumab), formerly called SB-11.
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