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Home » Topics » Regulatory

Regulatory
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WHO warns of counterfeit COVID-19 drugs

March 9, 2022
By Mari Serebrov
With the pandemic lingering across the world and more COVID-19 therapies becoming available and in demand, the opportunity for counterfeits is growing.
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On a back burner for decades, Potaba’s US approval finally to come to an end

March 9, 2022
By Mari Serebrov
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.
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Regulatory actions for March 9, 2022

March 9, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BBS-Bioactive Bone Substitutes, Cionic, Medmira.
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Regulatory actions for March 9, 2022

March 9, 2022
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.
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FDA approved icons and medical professional

FDA approves Axonics’ recharge-free sacral neuromodulation system

March 8, 2022
By Annette Boyle
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.
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Reducer device

Neovasc wins extensions of two patents for company’s Reducer device

March 8, 2022
By Mark McCarty
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.
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Map of China

Junshi and Mabwell’s adalimumab biosimilar wins NMPA approval

March 8, 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.
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Flag of Australia, sky background

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

March 8, 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.
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Shionogi aims for Japan’s first conditional approval for COVID-19 treatment

March 8, 2022
By Gina Lee

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. 


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Mallinckrodt settles US Acthar claims

March 8, 2022
By Mari Serebrov
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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