Pfizer Canada (NYSE:PFE) has warned Health Canada that there is a shortage of 0.3 mg EpiPen auto-injectors due to a manufacturing disruption. The company, which licenses the emergency allergy treatment from Mylan (NSDQ:MYL), reported that the problem should be resolved by March 2. Get the full story at our sister site, Drug Delivery Business News.
Smiths Medical has amended an urgent medical device recall that it first issued in August for its Medfusion syringe pump model series 3500 and 4000. After acknowledging that a defect in certain models of the pump can cause an “invalid syringe size” alarm to go off, the company added an option for facilities with trained staff […]
The Senate finance committee has approved president Donald Trump’s nominee for chief of the Dept. of Health and Human Services, Alex Azar. The former drug company executive is expected to be confirmed by the full Senate. If confirmed, Azar will succeed Tom Price, who was forced out after reports from Politico revealed he often used pricey charter […]
A consortium made up of 300 hospitals – and counting – are taking a bold step to address high drug prices and shortages of essential medicines: they’re cutting out the pharma middleman and starting their own non-profit generic drug company. The move is a first of its kind, according to a report from The New York […]
Valeritas (NSDQ:VLRX) said today that its V-Go wearable insulin delivery system is available in Puerto Rico. The Bridgewater, N.J.-based company has partnered with Fusion Consulting group to promote V-Go to Puerto Rico-based endocrinologists and general practitioners with Type II diabetes patients. Get the full story at our sister site, Drug Delivery Business News.
Early-stage life science fund BioAdvance announced that it has added an array of new companies to its portfolio, investing nearly $3.2 million into companies from the mid-Atlantic region of the U.S. Two of the firm’s largest investments went to Opsidio, a Bryn Mawr, Penn.-based company developing monoclonal antibodies to treat fibrotic diseases, and New York-based Pillo Health, […]
FDA commissioner Dr. Scott Gottlieb expects that the shortage of IV fluids caused by Hurricane Maria in Puerto Rico will improve in the coming weeks and months, according to a statement issued by the agency yesterday. The regulatory chief said that the FDA is working with manufacturers like Baxter (NYSE:BAX) and B. Braun to import products from foreign facilities into the […]
WaveForm Technologies said today that it has finished four clinical trials of its continuous glucose monitoring system and that it expects to win CE Mark clearance for the device this year. The WaveForm CGM system is designed to be worn for 14 days and includes a sensor insertion tool, a small sensor wire, a polymer coating […]
Aprinoia Therapeutics said today that it has raised $11.1 million in a Series B round, led by KTB Network and DCI Partners. The Taiwan-based biotech plans to use its new funds to advance the preclinical and clinical development of its tau PET imaging tracer and therapy programs for people with Alzheimer’s disease. Get the full story […]
Voluntis has inked a commercial deal to combine its insulin titration tech with WellDoc‘s coaching platform to create a digital management solution for people with Type II diabetes. Cambridge, Mass.-based Voluntis has developed an FDA-approved system, Insulia, which provides automated insulin dose recommendations that can be monitored remotely by a patient’s healthcare team. WellDoc’s BlueStar program gives […]
The FDA has placed an indefinite hold on implementing new regulations relating to how the agency determines a medical product’s intended use. The decision to press pause on the new rules drew cheers from the medical device and pharmaceutical industries, after companies voiced their concerns last year that the proposed changes were unclear. Get the […]