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FDA Approved stamp with blister pack

Fixes proposed for US accelerated approval path

March 8, 2022
By Mari Serebrov
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.
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Regulatory actions for March 8, 2022

March 8, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Quotient, Saluda Medical, Sense.
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Regulatory actions for March 8, 2022

March 8, 2022
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.
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FDA begins work on BsUFA III pilot

March 7, 2022

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.


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Flag of Australia, sky background

Australia introduces patent box legislation for med-tech and biotech innovations

March 7, 2022
By Tamra Sami
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.
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Regulatory actions for March 7, 2022

March 7, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artventive Medical, Biobot Surgical, Mawi DNA Technologies.
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Regulatory actions for March 7, 2022

March 7, 2022
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.
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Skin, tissue layer illustration

Sihuan awarded medical device registration for skin repair products by NMPA

March 4, 2022
By Doris Yu
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.
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Map of China

Junshi and Mabwell’s adalimumab biosimilar wins NMPA approval

March 4, 2022
By Doris Yu
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.
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Regulatory actions for March 4, 2022

March 4, 2022
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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