Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Microtransponder.
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.
The wave of home-use tests for the COVID-19 pandemic has amplified the question of how device makers might validate such a test, but there is also the question of how to convert a device from prescription-only (Rx-only) use to over-the-counter (OTC) status to consider. The FDA has provided an update on OTC devices, which indicates that a conversion from prescription-only use to OTC use will require usability testing and a new regulatory filing, but the update conflicts with the agency’s own policy on changes to a device undertaken only to convert the label from prescription to OTC use.
The FDA has posted an advisory regarding robotically assisted surgery (RAS) for mastectomy, but the agency also pointedly noted that it is aware of studies underway for such indications without the appropriate oversight. The FDA did not name Intuitive Surgical Inc. in the notice, but the company nonetheless responded to the FDA statement by confirming the absence of any devices thus approved or cleared. The FDA had previously issued a Feb. 28, 2019, advisory stating that the safety and efficacy of RAS devices for mastectomy and the prevention or treatment of breast cancer had not been established.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fuse Medical, FX Shoulder, Thermo Fisher.
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.
With the Americas having the dubious distinction of the most COVID-19 cases in the world, the Pan American Health Organization (PAHO) is answering that “wake-up call” with plans to develop a collaborative platform to develop mRNA vaccine production in Latin America and the Caribbean.
Ascendis Pharma A/S kept mum on the cost of just-approved Skytrofa (lonapegsomatropin) for pediatric growth hormone deficiency (GHD) – saying only that “premium responsible pricing” would be put in place – but Wall Street speculated freely about revenues likely due from the first-ever weekly injection treatment.
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