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).
The FDA has granted Magstim Co. Ltd. 510(k) clearance for its transcranial magnetic stimulation (TMS) platform Horizon 3.0. TMS is a series of repetitive, focused magnetic pulses, used to stimulate brain cells. The noninvasive therapy has been touted as a cost-effective treatment for depression and is typically prescribed when antidepressants have failed, or the side effects are too disruptive to a patient’s lifestyle.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Lumos Diagnostics, Mim Software.
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.
Eli Lilly and Co. has withdrawn a filing for its COVID-19 antibody cocktail in Europe after health authorities backed rivals – the day after a $1.29 billion purchase of the same medicines from the U.S. government. Indianapolis-based Lilly began filing data from the combination of bamlanivimab and etesevimab in March to enable a fast authorization by the European Medicines Agency.
The FDA convened a Nov. 2 advisory panel to review the data for the AFX2 by Endologix LLC, of Irvine, Calif., with some indication that the agency believes the data suggest a poor benefit-risk ratio when used in treatment of abdominal aortic aneurysms (AAAs). The panel concluded that the benefits of the device do outweigh the risks for some patients, although the applicable patient population is likely to be smaller than is currently seen in clinical practice.
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