Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asensus Surgical, Endosound, Immunolight, In2bones, Intelivation Technologies, Rehabtronics, Tyber Medical.
Bristol Myers Squibb Co.’s Opdivo (nivolumab) is now the first and only immunotherapy for the first-line treatment of advanced gastric cancer in China.
In another cautionary tale for JAK inhibitors, the U.S. FDA is requiring updated boxed warnings for three drugs in the class that are approved to treat inflammatory conditions – Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and Abbvie Inc.’s Rinvoq (upadacitinib).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, ANI, Genhouse, Gloria, Huya, Innocare, Jazz, Ligand, Medipharm, Medivir, Merz.
U.S. Attorney General (AG) Merrick Garland has rescinded two important policy documents, including the Brand memo, which limited the ability of federal prosecutors to use non-compliance with federal agency guidance as proof of violations of the law. The rescission of these memos increases the risk that drug and device companies will be prosecuted more vigorously due to deviation from FDA guidance documents, which at times conflict with other guidances and thus may create a series of nearly unavoidable compliance failures.
The FDA has designated Impedimed Ltd.’s Sozo digital health platform a breakthrough device for renal failure, paving the way for the first FDA approved device to measure fluid volume in the dialysis setting.
Vuno Inc. received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for Vuno Med Deepcars, its artificial intelligence (AI) medical device for cardiac arrest prediction. Approval in hand, Seoul-based Vuno will push for wider adoption of its biosignal-based AI technology. Vuno Med Deepcars predicts the probability of cardiac arrest occurring within a 24-hour period by analyzing a patient’s pulse, respiratory rate, diastolic and systolic blood pressure as well as body temperature. The data is collected from the electronic medical record of hospitalized patients.
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.
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