Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Diamedica, Eton, Liquidia, Ocugen, Prelude, Seelos, Soligenix.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bharat, Novavax, Nrx, Ocugen, Opiant, Tris.
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).
A few hours after the U.S. CDC Advisory Committee on Immunization Practices’ Nov. 2 recommendation to allow children ages 5 through 11 to be administered Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), the agency’s director, Rochelle Walensky, endorsed the recommendation. The recommendation came as the World Health Organization (WHO) expanded the COVID-19 vaccines it recommends in the fight against the pandemic by endorsing Bharat Biotech International Ltd.’s Covaxin.
The FDA has one question for its Psychopharmacologic Drugs Advisory Committee when it meets Nov. 4: Has Levo Therapeutics Inc. provided substantial evidence that the company’s carbetocin nasal spray is effective in treating hyperphagia associated with Prader-Willi syndrome?
It looks like direct Medicare drug price negotiations are back in the U.S. fiscal 2022 budget bill.
Nearly a week after President Joe Biden dropped drug pricing reforms from his Build Back Better budget framework, congressional Democrats came together on a scaled-back version of the pricing provisions originally included in H.R. 3.
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