Altimmune obesity drug well-positioned despite safety data
Altimmune released mid-stage data Tuesday showing pemvidutide helped reduce patients’ weight by 10%, but the company’s shares tumbled 55% over safety concerns with the obesity drug.
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US FDA expands use of Regeneron’s cholesterol drug in young children
/in TherapeuticsThe expanded approval makes Regeneron’s Evkeeza the first drug to treat kids under 10 with the condition.
Novartis scraps UK heart attack prevention trial
/in TherapeuticsUnder the ORION-17 trial, planned to involve 40,000 patients, Novartis was trying to show that its Leqvio drug could prevent the first occurrence of major cardiovascular health problems in high-cholesterol patients, part of a broader collaboration with the British health system.
Roche teams up with Lilly to validate Alzheimer’s blood test
/in R&D, TherapeuticsRoche and Eli Lilly are joining forces to develop a blood test for Alzheimer’s disease, and plan to kick off a two-year clinical trial involving hundreds of volunteers with the aim of winning U.S. regulatory approval.
APACMed Names EVERSANA Knowledge Partner to Shape Digital Health Reimbursement Framework Across Region
/in Marketing & AdvertisingAsia Pacific Medical Technology Association (APACMed), the region’s leading organization for medical technology manufacturers, has named EVERSANA, a pioneer of next-generation commercial services to the global life sciences industry and a market leader in helping digital health technology innovators navigate the complexity of bringing new therapies to patients, as its knowledge partner across Asia Pacific countries.
Mereo forges ahead with PRO Trial Design for lung disease program
/in TherapeuticsFollowing recent meetings with the FDA and European Medicines Agency (EMA), Mereo Biopharma is designing a Phase III study of alvelestat to treat alpha-1-antitrypsin deficiency-associated lung disease.
Candida auris fungus spreading in U.S. hospitals – CDC
/in TherapeuticsPotentially deadly fungal infections with Candida auris are spreading rapidly in U.S. healthcare facilities, with cases nearly doubling between 2020 and 2021, the Centers for Disease Control and Prevention said.
The rise, fall and future of Novavax
/in TherapeuticsOn February 28, Novavax issued a candid warning to investors: it may not be able to continue operations beyond February 2024.
US FDA to take steps to help gene therapies get accelerated approval
/in Therapeutics“The FDA views gene therapy as an excellent opportunity to expedite the delivery of potentially life-saving therapies to patients with rare diseases,” said Marks, who heads the FDA’s Center for Biologics Evaluation and Research, in a statement.
Biden signs bill requiring declassification of COVID origins information
/in TherapeuticsWashington has been conducting a highly politicized debate about the origins of the coronavirus pandemic almost since the first human cases were reported in the Chinese city of Wuhan in late 2019, amid calls from both Biden’s fellow Democrats and Republicans to push back harder against a rising China.
