Holly Hand, a New York-based senior project manager overseeing a clinical trial for Neuralstem Inc. (now Seneca Biopharma Inc.), agreed to pay $103,875 to resolve an SEC complaint of insider trading.
In a bid to bring more drug manufacturing back to the U.S. and to ensure an adequate supply of essential medicines, even in public health emergencies, the U.S. Department of Health and Human Services is forming a public-private consortium on advanced manufacturing and the onshoring of domestic production.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbive, Alessa, Amicus, Amryt, Ascletis, Bavarian Nordic, Bergenbio, Bluebird, Cantargia, Crestone, Cullinan, Iaso, Incyte, Kiniksa, Liminal, Moderna, Neoimmunetech, Novo Nordisk, Spinogenix Takeda, VBI.
Imagine an orthopedic implant that not only accelerates bone healing but also captures data to support real-time clinical decisionmaking. That’s the vision of Intelligent Implants Ltd., whose Smartfuse system recently won FDA breakthrough device designation. The first indication is for lumbar spinal fusions.
LONDON – The U.K. health technology assessment agency, NICE, has called for a halt to the use of transvaginal laser therapy in the treatment of urinary stress incontinence and vaginal atrophy, saying there is not enough evidence of long-term safety, or proof that the procedures are effective.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta Group, Medtronic, Opgen, Orasure Technologies.
The European Commission unveiled its third alternative to providing global access to COVID-19 vaccines and treatments just ahead of the June 8 meeting of the World Trade Organization’s Council for Trade Related Aspects of Intellectual Property Rights and the start of the G7 summit.
Sinovac Biotech Ltd.'s inactivated COVID-19 vaccine, Coronavac, has been approved by Chinese regulators for emergency use in children aged between 3 and 17, the company’s CEO Yin Weidong told Chinese state media on June 4. Sinovac briefly unveiled phase I/II data in the age group back in April. Chinese state media, China Central Television, said it confirmed the news with an expert from China’s State Council, though an official announcement has yet to be made. Sinovac did not immediately respond to BioWorld’s query to confirm the news.
The FDA has lifted clinical holds on four studies from Bluebird Bio Inc., following recent similar actions with other gene therapy programs. Two of the studies concern phase I/II and phase III clinical trials of the gene therapy Lentiglobin (BB-1111) in treating sickle cell disease. The remaining two studies are phase III clinical trials of betibeglogene autotemcel gene therapy, which share a vector with Lentiglobin, for treating transfusion-dependent beta-thalassemia.
Novo Nordisk A/S will this month launch its weekly weight loss glucagon-like peptide-1 injection Wegovy (semaglutide) at the same monthly cost as its older daily shot Saxenda (liraglutide), following FDA approval in overweight and obese adults.
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