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.
Although COVID-19 is still dictating how things are done in the U.S. and throughout the world, the FDA looked beyond the pandemic in an update to its guidance on conducting clinical trials of medical products during the public health emergency.
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 FDA has released two draft guidances under the safety and performance-based pathway for class II devices, proving some much-needed momentum for the agency’s fiscal year 2021 guidance agenda. The two drafts address performance metrics for facet screw systems and the use of resins in dentures, thus adding substantially to the number of class device types that can be reviewed outside the usual substantial equivalence mechanism ordinarily relied upon in the 510(k) program. The FDA began implementing the safety and performance-based pathway for devices in late 2019, an approach that serves as a substitute for the abbreviated 510(k) mechanism.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Impedimed, Phase Scientific, Vapotherm, Visby Medical.
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.
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