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Mellitus Health, Smart Meter ink insulin titration deal
Mellitus Health and Smart Meter inked a partnership this week to combine real-time blood glucose data with insulin titration tech. According to the terms of the deal, healthcare providers using...
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Teva wins FDA nod for sublingual film to treat opioid dependence
The FDA last week approved Teva Pharmaceuticals’ Cassipa buprenorphine and naloxone sublingual film as a maintenance treatment for opioid dependence. There are a number of brand name and generic...
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Boston Scientific launches trial for drug-eluting peripheral stent
Boston Scientific (NYSE:BSX) said last week that it enrolled the first patient in a pivotal trial to evaluate its below-the-knee drug-eluting stent in patients with critical limb ischemia. The...
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Medtronic launches one-month DAPT study for drug-eluting stent in U.S., Japan
Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting...
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10 exhibitors at DeviceTalks Boston you should know
DeviceTalks Boston is an annual event that allows some of the best minds in medtech to exchange ideas, insights and technologies. Medical Design & Outsourcing’s parent company WTWH Media holds...
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Insulet promotes COO to corner office as CEO Sullivan sets retirement date
Insulet (NSDQ:PODD) announced this week that president & COO Shacey Petrovic will succeed CEO Patrick Sullivan after he retires at the end of the year. Petrovic plans to stay on as president of the...
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Siga lands $629m BARDA contract to stockpile smallpox treatment
Siga Technologies (NSDQ:SIGA) said today that it signed a multi-year contract with the Biomedical Advanced Research & Development Authority to provide oral and intravenous versions of Siga’s Tpoxx...
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PCI Pharma Services to buy Sherpa Clinical Packaging
PCI Pharma Services has agreed to acquire clinical supply services provider Sherpa Clinical Packaging, the companies announced today. Financial terms of the deal were not disclosed. San Diego–based...
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FDA pushes back decision date for Acorda’s Parkinson’s drug
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA pushed back its goal date for the agency’s review of Acorda’s inhaled levodopa Parkinson’s therapy. The FDA’s date to make a decision about...
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Mylan launches generic Brevibloc heart injection
Mylan (NSDQ:MYL) said today that it launched a generic version of Baxter‘s (NYSE:BAX) Brevibloc heart drug in the U.S. The company’s injectable product, esmolol hydrochloride in sodium chloride, will...
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FDA to review Regeneron’s Eylea for diabetic retinopathy
Regeneron Pharmaceuticals (NSDQ:REGN) said today that the FDA plans to review the supplemental biologics license application for Regeneron’s Eylea aflibercept injection for the treatment of diabetic...
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Genentech wins FDA nod for subcutaneous formulation of arthritis drug
Roche‘s (OTC:RHHBY) Genentech reported this week that the FDA approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients two...
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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...
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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...
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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,...
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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...
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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....
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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...
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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...
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NIH kicks off study of combo antibody HIV therapy
Image courtesy of NIAID 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...
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