Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antares, Astrazeneca, BMS, Canbridge, CSL, Daewoong, Enanta, Immunogen, Mitsubishi Tanabe, Neurocrine, Novo Nordisk, Noxopharm, Reveragen, Santhera, Takeda, Urogen, Telix.
The ongoing tension between manufacturers of imaging systems and entities that perform extensive servicing activities has prompted activity on Capitol Hill in the form of H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act.
After more than 10 years on the market in Europe, Staar Surgical Co. can finally see a brighter future for its newest lenses in the U.S. This week, the company received FDA premarket supplement approval of its Evo/Evo+ Visian implantable lens for the correction of myopia and myopia with astigmatism in patients aged 21 to 45. Made of a proprietary poly(2-hydroxyethyl methacrylate)-based collagen co-polymer the company calls Collamer, the lens is inserted behind the iris in a quick procedure and can be removed, if needed. Unlike laser-assisted in situ keratomileusis (LASIK), the Evo procedure does not remove corneal tissue.
Biobeat Technologies Ltd. reported its remote patient monitoring system received FDA clearance to monitor respiratory rate and body temperature. The wireless chest and wrist monitoring device is already cleared for cuffless blood pressure monitoring, blood oxygen saturation and pulse rate. The artificial intelligence platform utilizes a photoplethysmography-based sensor at the surface of the skin that measures volumetric variations of blood circulation.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cellmyx, Envista.
Sanofi SA’s enzyme replacement therapy, Xenpozyme (olipudase alfa), has been approved for use in Japan, making it the world’s first and only approved therapy to treat acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick type B disease. Sanofi’s executive vice president and global head of R&D, John Reed, hailed it as a “watershed moment” that was the culmination of 20 years of research.
The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study.
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA.
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