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Insulia wins FDA nod, CE Mark clearance to titrate Tresiba, Basaglar insulin
Voluntis said today that its digital management system for people with Type II diabetes, Insulia, won FDA clearance and CE Mark approval to integrate basal insulin brands Tresiba and Basaglar. The...
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Shares in Delcath fall after losses grow in Q3
Shares in Delcath Systems (NSDQ:DCTHD) crashed today after the company posted its third quarter results, revealing that the company’s net losses have grown dramatically quarter-over-quarter. The...
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Researchers reverse diabetes in mice by infusing them with blood stem cells
Researchers at Boston Children’s Hospital successfully reversed Type I diabetes in a mouse model using blood stem cells, according to a study published this week in Science Translational Medicine. The...
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iVeena finishes pilot trial of sustained-release implant
iVeena Delivery Systems said earlier this month that it finished a pilot trial for its IVMED-10 bioerodible implant designed to treat pain and inflammation after cataract surgery. Placed during...
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JDRF touts win after Anthem decides to cover artificial pancreas systems
JDRF said today it successfully persuaded Anthem to cover artificial pancreas systems, after meeting the health insurer as part of is Coverage2Control campaign. America’s 25 largest health insurers now...
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Here’s what the FDA is doing about IV fluid shortages following hurricanes...
Nine weeks after hurricanes Maria and Irma brought devastation to Puerto Rico, FDA commissioner Dr. Scott Gottlieb says hospitals across the U.S. are reporting shortages of IV fluids – medical products...
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Amgen launches Enbrel Mini single-dose cartridges with reusable auto-injector
Amgen (NSDQ:AMGN) announced today the U.S. launch of its Enbrel Mini single-dose prefilled cartridges, which are delivered using a reusable AutoTouch auto-injector. The drug-device combination was...
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After FDA nod, Flexion launches osteoarthritis injection
Flexion Therapeutics (NSDQ:FLXN) today launched its Zilretta therapy designed to help patients manage pain associated with osteoarthritis of the knee. The Burlington, Mass.-based company’s...
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FDA approves Kaleo’s allergy auto-injector designed for infants
The FDA has approved Kaleo‘s Auvi-Q epinephrine auto-injector designed to treat life-threatening allergic reactions in infants and small children, according to the privately-held biopharma company. The...
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Orexo nabs regulatory win for fast-dissolving opioid dependence therapy
Orexo (STO:ORX) said today that the European Medicines Agency granted marketing authorization for its Zubsolv rapidly-disintegrating treatment for opioid dependence. The buprenorphine and naloxone...
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Milestone Scientific plans launch for Botox injection device
Milestone Scientific (NYSE:MLSS) said today that it plans to launch a cosmetic injection instrument designed to deliver botulinum toxin. The company’s new drug delivery instrument is slated to include...
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Aridis uses human antibodies to fight against “time bomb” of antibiotic...
Although antibodies have gained plenty of ground in recent years as vehicles for cancer therapies, Aridis Pharmaceuticals wants to use them as nature intended – to fight infection. “These are human...
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Dexcom, Lilly ink deal to combine CGM into smart insulin delivery device
Dexcom (NSDQ:DXCM) said today that it inked a development deal with Eli Lilly (NYSE:LLY) to include its continuous glucose monitor in the insulin-maker’s connected delivery devices. The pair plans to...
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Fresenius Kabi to invest $100m in North Carolina manufacturing site
Fresenius (NYSE:FMS) business group Fresenius Kabi said today that it plans to invest more than $100 million over the next five years in a Wilson, N.C.-based manufacturing site. The company’s expansion...
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Restasis buyers level antitrust lawsuit against Allergan
A proposed class of Restasis buyers filed an antitrust suit last week in a Texas federal court against Allergan (NYSE:AGN), according to reports from Law360. The suit accuses Allergan of blocking...
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Using digital pills, researchers find patients consume fewer opioids than...
Clinicians at Brigham and Women’s Hospital published a paper in the December issue of Anesthesia & Analgesia showing that digital pills successfully monitored patients taking opioids following an...
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Facing pressure in diabetes, Novo Nordisk plans next big push – obesity
The world’s largest diabetes drug-maker, Novo Nordisk (NYSE:NVO), is reportedly looking to boost its efforts to treat obesity as the company’s well-established diabetes drugs face competition. At Novo...
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FDA wants to improve access to generic abuse-deterrent opioids: here’s how
The FDA commissioner, Dr. Scott Gottlieb, has made the opioid crisis a priority in his time at the agency. Yesterday, the regulatory body issued guidance to help promote the development of generic...
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GSK, Innoviva seek expanded label for triple inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler. The...
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How Enable Injections plans to bring value to pharma with its drug-delivery...
Mike Hooven is no stranger to the medical device industry – he has spent the last 30 years launching companies and developing technologies for a variety of clinical applications. So when he ventured...
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