Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Neurologica.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7 Hills, Acadia, Altamira, Antengene, Bayer, Biomind, C4, Merck & Co., Orion.
The FDA and device makers have finally wrapped up what may be the most contentious set of negotiations in the history of the device user fee program. Despite industrial antipathy to a recurrent doubling of user fee volumes, the fifth device user fee deal will provide the FDA with as much as $1.9 billion in user fees, roughly double the fees collected under the current agreement.
Sense Biodetection Ltd. is preparing to launch a new rapid, disposable, point-of-care molecular diagnostic test for COVID-19 in Europe after securing CE marking for the platform. The company will make its Veros COVID-19 test available in Ireland, Benelux and Nordic countries this quarter before expanding to other European markets.
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.
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