Lyme disease vaccine candidate VLA15 from Valneva has been granted fast-track designation by the FDA. Enrollment for an early-stage study of the vaccine has been completed by the company, which expects initial results from the Phase I trial and also plans to initiate a midstage study in the first quarter of next year.
Gilead Sciences and GlaxoSmithKline, among others, are building on the success of antiretrovirals against HIV. Gilead is seeking approval for integrase inhibitor bictegravir, GSK is testing a long-acting injection of two drugs, and Johnson & Johnson, working with public and private partners, will begin a large-scale midstage vaccine trial in Africa later this year.
GlaxoSmithKline's self-injectable formulation of Benlysta, or belimumab, has been approved by the FDA as a treatment for adult patients with active, autoantibody-positive systemic lupus erythematosus who receive standard therapy. The company will release the new formulation late next month.
The FDA granted seven years of orphan-drug exclusivity to CSL Behring's Haegarda, or C1 esterase inhibitor subcutaneous.
Vifor Pharma's Veltassa received approval from European regulators to be marketed in the European Union, Liechtenstein, Norway and Iceland as a treatment for adult patients with hyperkalemia including those who are on renin angiotensin aldosterone system inhibitor therapy. The drug is anticipated to be launched in the areas where it received approval by early 2018.
Teva's Cinqaero, or reslizumab, was recommended by the National Institute for Health and Care Excellence as a treatment for patients with severe eosinophilic asthma after NICE considered not recommending it last year. Data showed that use of the drug significantly reduced the frequency of clinical asthma exacerbations versus placebo use.
A nationwide recall was issued by Bush Brothers for three flavors of canned baked beans because the cans they were packaged in were defective, which could lead to spoilage or contamination with pathogens. Brown Sugar Hickory, Country Style and Original varieties of the canned baked beans, which were sold in 28-ounce cans at retailers nationwide, were part of the recall.
A draft guidance was released by the Indian government under its impending Medical Devices Rules, set to take effect next year, to outline the fundamental design and manufacturing requirements of safety and performance for medical devices and in vitro diagnostic products. The draft, which was developed through consultation with industry stakeholders, is open for comments for the next three weeks.
Pops! Diabetes Care said the first patient in a trial of its Pops! one device for blood glucose testing has been enrolled in partnership with the Children's Minnesota health care system. The device, which attaches to a cellphone and transmits readings to the company's cloud-based app via Bluetooth connection, will be tested in up to 50 patients ages 10 to 25 years who have type 1 diabetes and need multiple insulin injections per day but who do not use an insulin pump.
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