On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. “Over the past decade, we’ve […]
NIH kicks off study of combo antibody HIV therapy
The National Institutes of Health reported this week that it launched a clinical trial evaluating a combination of antibodies in people with HIV. The early-stage study is designed to assess whether periodic infusions of two HIV-specific antibodies are safe in people living with HIV. Researchers also plan to gather preliminary data assessing how effectively the […]
SFC Fluidics wins $1.4m grant to develop dual-hormone patch pump
SFC Fluidics said today that it won a $1.4 million grant to support the development of a dual-hormone patch pump for people with diabetes. The company’s ePump system is designed to control the delivery of insulin and glucagon via a small patch pump. The technology will also feature a flow confirmation sensor to determine, in […]
EU approves fifth biosimilar for blockbuster Humira drug
Mylan (NSDQ:MYL) and Fujifilm Kyowa Kirin Biologics said today that the European Commission gave the companies marketing authorization for Hulio, a biosimilar to AbbVie‘s (NYSE:ABBV) billion-dollar Humira product. Mylan said it plans to launch Hulio across particular markets in Europe on or after Oct. 16. The drug is the fifth product authorized by the EC as […]
Clovis forks over $20m to settle SEC charges that it misled investors
The SEC said today that Clovis Oncology (NSDQ:CLVS), its CEO and former CFO will pay more than $20 million to settle charges that the company misled investors about its experimental lung cancer drug. The SEC alleged that beginning in July 2015 and over the course of a four-month period, CEO Patrick Mahaffy and his team […]
AstraZeneca touts long-term safety, efficacy data for asthma biologic
AstraZeneca (NYSE:AZN) today touted results from a Phase III extension trial evaluating the long-term safety and efficacy of benralizumab as an add-on maintenance therapy for patients with severe eosinophilic asthma. Benralizumab, or Fasenra, is approved as an add-on maintenance treatment for severe eosinophilic asthma in an array of countries, including the U.S., the E.U., and Japan. […]
Researchers launch early-stage trial for nasal flu vaccine
Researchers at St. Louis University reported that an early-stage trial testing an experimental nasal flu vaccine in children and teens began enrolling participants this week. In the 50-person study, half of the participants will receive the investigational nasal vaccine and the other half will receive an inactive saline solution. All of the study’s participants are […]
Medtronic joins initiative to bring more women into the board room
Medtronic (NYSE:MDT) said today that it joined the Catalyst CEO Champions For Change initiative, pledging to add more women to its executive team and board of directors. The medtech titan teamed up with global nonprofit Catalyst and promised that it would “strengthen the pipeline of women” within the organization using annual reviews and data tracking. Get […]
NIH study finds daily aspirin does not prolong healthy lifespan
In a 19,114-person trial supported by the National Institutes of Health, researchers found that daily low-dose aspirin did not prolong independent living in healthy older adults. Initial findings from the Aspree trial, which began in 2010, were published in The New England Journal of Medicine this week. The study involved participants who did not have […]
Teva wins FDA nod for migraine prevention drug
Teva (NYSE:TEVA) last week won FDA approval for its humanized monoclonal antibody, Ajovy, designed to prevent migraines. The treatment, which blocks the receptor for a protein that is linked to migraine pain, is available in quarterly and monthly-injection options. Amgen‘s (NSDQ:AMGN) competitive once-monthly product won FDA approval earlier this year. Teva studied Ajovy in two Phase […]
