The FDA granted Austin, Texas-based International Biophysics 510(k) clearance for its FloPump 32 centrifugal disposable heart pump, which is intended to be used with the RotaFlow console from Getinge subsidiary Maquet Cardiovascular. The device will be distributed solely by Origen Biomedical in the US and in Canada if approved by Health Canada next year.
Ipsen and Exelixis stopped a late-stage trial evaluating Cabometyx as a treatment for patients with advanced liver cancer after achieving positive data showing the primary endpoint of overall survival was met. Results from the trial demonstrated 10.2 months of mean overall survival in patients taking Cabometyx versus eight months with placebo use.
Janssen's Darzalex, or daratumumab, was endorsed by the National Institute for Health and Care Excellence for use in adults who have received previous treatment for multiple myeloma. The treatment will be available through the Cancer Drugs Fund.
The indictment against Beny Mesika, who was a co-founder of DuraCap Labs, has expanded and now includes his wife, Elizabeth Kuecher, who allegedly conspired with her husband to produce and distribute dietary supplements that included illegal synthetic steroid compounds. The new indictment also widened the charge count from 12 to 25, adding charges of smuggling prohormones and unlawful stimulants, failure to register four food facilities and laundering money through multiple accounts.
The V-Go wearable insulin delivery system was introduced by Bridgewater, N.J.-based Valeritas in Puerto Rico. The product will be promoted to endocrinologists and general practitioners whose patients have type 2 diabetes through a partnership with Fusion Consulting Group, which will be in charge of sales activity; product development, manufacturing, regulatory approval and quality management will be handled by Valeritas.
A safety warning was released by the FDA alerting users of Zoll Medical's external, wearable cardioverter defibrillator LifeVest 4000 that the device may not be able to deliver treatment for potentially fatal arrhythmias after displaying a message that the user should call the company for service. This failure, which was associated with one death, may be caused by "a fault that prevents the device from charging its high-energy capacitors," the agency said.
Merck will collaborate with Cancer Research UK and the Institute of Cancer Research, London to develop biomarkers and advance three drug candidates for cancer treatment. Under the terms of the deal, Merck will pay Cancer Research and ICR for achieving milestones, plus royalties.
The International Institute of Tropical Agriculture received permission from the National Biosafety Management Agency to commence confined field trials of biotech cassava in Nigeria. The research will be conducted in collaboration with Zurich's ETHZ Plant Biotechnology Laboratory.
A previously announced private offering of additional 4.375% senior notes due 2025 and 4.625% senior notes due 2028 was priced by Hologic at $1,000 per $1,000 in hopes of raising $1 billion. The net proceeds, along with available cash, will be used for the redemption of outstanding 5.25% senior notes due 2022.
- Page 1