A U.S. district court jury in Boston found Nov. 5 that Gregory Lemelson and Massachusetts-based Lemelson Capital Management LLC made fraudulent misrepresentations about Ligand Pharmaceuticals Inc. to drive down the San Diego company’s stock price.
Shares in Rewalk Robotics Ltd. are on the rise after the FDA awarded its Reboot exoskeleton device breakthrough device designation status. The wearable, battery-powered device is designed to assist individuals with lower limb disability due to stroke.
The U.K. National Institute for Health and Care Excellence said in a new health technology assessment that cardiac resynchronization devices using the Enduralife battery by Boston Scientific Corp. (BSX), are ready for prime time in the U.K. national health system.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Flume Catheter.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bharat, Novavax, Nrx, Ocugen, Opiant, Tris.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Telix Pharmaceuticals Ltd.’s lead prostate cancer imaging agent, Illuccix. Illuccix (TLX591-CDx) is a Gallium-based PSMA imaging agent and cold kit for developing radiopharmaceutical products and diagnostic agents. Telix’s prostate cancer program consists of a companion diagnostic imaging agent (TLX591-CDx) and a therapeutic (TLX-591) to improve the detection and treatment of prostate cancer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rewalk Robotics.
A closely watched oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Britain after a conditional authorization by the U.K. Medicines and Healthcare products Regulatory Agency. Developed by Ridgeback Biotherapeutics Inc. and Merck & Co. Inc., the drug will be marketed as Lagevrio (molnupiravir) and made available via a national study this winter, the government said.
Compelling testimony from parents who saw life-altering changes in their children who participated in Levo Therapeutics Inc.’s intranasal carbetocin clinical trial wasn’t enough to counter what the FDA’s Psychopharmacologic Drugs Advisory Committee saw as a lack of “substantial evidence” to support the drug’s effectiveness in treating hyperphagia associated with Prader-Willi syndrome (PWS).
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