The potholes in the U.S. FDA’s accelerated approval path could be paved over by a bill introduced in Congress this week. Rep. Frank Pallone (D-N.J.), chair of the House Energy and Commerce Committee, introduced the Accelerated Approval Integrity Act March 8 to keep the path open to innovative drugs where there is unmet need while streamlining the process for taking drugs off the market when they don’t prove clinical benefit in a timely manner.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Quotient, Saluda Medical, Sense.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpine, BMS, Boehringer, Eli Lilly, Harpoon, Horizon, Sanbio, Servier.
Even though Congress isn’t likely to approve BsUFA III for several months, the FDA is getting a jump on one of the BsUFA commitments it negotiated with industry to pilot a regulatory science program to facilitate the development of biosimilars and interchangeables.
New legislation providing a tax incentive for Australian medical innovations was introduced in Australia’s House of Representatives, and industry stakeholders are lauding the move. The measure, providing a special tax regime on income derived from patents, a “patent box,” will apply for income years beginning on or after July 1.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artventive Medical, Biobot Surgical, Mawi DNA Technologies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Aravax, Bharat Biotech, Biogen, Eisai, Merck, Nymox, Ocugen.
China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform, Beijing Meiyan Kongjian Biology Medicine Co. Ltd.
Shanghai Junshi Biosciences Co. Ltd. and Mabwell Bioscience Co. Ltd. have won marketing approval for the adalimumab biosimilar Junmaikang from China’s NMPA for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis, and psoriasis. It’s Mabwell Bio’s first commercial product.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Circa Scientific, KSL Diagnostics, SQI Diagnostics.
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