Medical devices and diagnostics are patent-dependent items, and companies may be able to avail themselves of extensions of their patents due to the time taken for FDA regulatory review. The U.S. Patent and Trademark Office announced March 8 that it had granted Neovasc Medical Ltd. a one-year extension of the term of two patents for the company’s flagship Reducer device, thus giving the company one additional year of market exclusivity to obtain the FDA’s approval for the device.
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.
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.
Shionogi and Co. Ltd. is looking to become the first company to get approval for a COVID-19 treatment under Japan’s conditional approval system as it prepares a phase III trial for S-217622 (ensitrelvir), its oral antiviral drug for COVID-19.
Mallinckrodt plc agreed to pay $260 million to resolve separate U.S. allegations that it violated the False Claims Act by underpaying Medicaid rebates for its H.P. Acthar Gel (corticotropin) and that it violated the anti-kickback law by using a foundation as a conduit to illegally pay Medicare patients’ copay subsidies.
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.
RSS
