With the pandemic lingering across the world and more COVID-19 therapies becoming available and in demand, the opportunity for counterfeits is growing.
After more than 50 years of trying, the U.S. FDA is finally withdrawing approval of Potaba (potassium aminobenzoate) tablets, capsules, powder, and other forms as well as any identical, related or similar products.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BBS-Bioactive Bone Substitutes, Cionic, Medmira.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Akeso, Apex, Genmab, Inventiva, Ixaka, Revance, Seelos, Tetra.
Axonics Inc. received FDA approval for its recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS) for bladder and bowel dysfunction. The F15’s primary cell requires no recharging or replacement for more than 15 years with normal use or 20 years at lower energy settings and the system is compatible with 1.5T and 3.0T full body magnetic resonance imaging scans.
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.
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