Ipsen (EPA:IPN) said today that the FDA approved a supplemental indication for its Somatuline depot (lanreotide) injection for the treatment of carcinoid syndrome. “The new indication for Somatuline depot offers patients in the U.S. a valuable treatment option for debilitating carcinoid syndrome associated with neuroendocrine tumors.,” Ipsen’s VP of R&D and chief scientific officer, Dr. Alexandre Lebeaut, […]
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Arkray launches diabetes diagnostic tech
Arkray‘s U.S. subsidiary launched today its Adams A1c HA-8180V system for hemoglobin A1c testing. The device is indicated to help diagnose and monitor people with diabetes, the Edina, Minn.-based company reported. “We are excited to bring this technology to the U.S. market. The ADAMS A1c HA-8180V builds on proven expertise. The Adams brand has been used globally […]
Braeburn’s buprenorphine depot wins priority review from FDA
Braeburn Pharmaceuticals said today that the FDA granted priority review to the company’s CAM2038 NDA. The investigational weekly and monthly buprenorphine depot injection was designed to treat adults with opioid use disorder. The regulatory agency is slated to make a decision about CAM2038 by January 10, 2018. “FDA’s acceptance of our NDA for CAM2038 under […]
LifeMine Therapeutics combines AI, drug discovery & microbes with $55m launch
Backed by the likes of Google and Merck (NYSE:MRK), Cambridge, Mass.-based LifeMine Therapeutics launched today by closing a $55 million Series A round. The company calls itself the first to “massively scale the genomic discovery of powerful new drugs from eukaryotic microbes”. LifeMine plans to use artificial intelligence to hunt down drugs hidden within the DNA […]
Report: FDA to tackle drug compounding policy
FDA commissioner Scott Gottlieb wants to encourage compounding pharmacies to register under a law that brings such businesses under the authority of the FDA rather than state pharmacy boards, according to new reports from Reuters. Pharmacies that specialize in compounding services make custom medications by combining, or compounding, FDA-approved drugs in strengths personalized to an individual […]
Teva sells off the rest of its women’s health assets in $2.5B deal
After the company divested its Paragard intrauterine device assets for $1.1 billion in cash last week, Teva Pharmaceuticals (NYSE:TEVA) announced today that it plans to sell off the rest of its global women’s health biz. Combined with proceeds from its Paragard deal, the sale of Teva’s global women’s health assets will total $2.48 billion, the company […]
Microneedle skin patch delivers fat-burning drug in mouse trial
Researchers have created a drug-filled microneedle skin patch that helps convert energy-storing fat, or white fat, into energy-burning fat, or brown fat – all the while boosting the body’s metabolism. The team of researchers at Columbia University Medical Center and the University of North Carolina reported that their patch could one day be used to burn […]
Medtech stories we missed this week: Sept. 15, 2017
From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to […]
Fast-dissolving opioid dependence tablet wins EU recommendation
Mundipharma International and Orexo (STO:ORX) said today that its fast-dissolving Zubsolv buprenorphine and naloxone sublingual tablet won a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The European Commission is slated to make a final decision about the product’s marketing authorization by the end of this year, the companies […]
Drug-carrying particle contains multiple doses of vaccine – in one injection
Researchers from Massachusetts Institute of Technology have invented a method to generate drug-ferrying particles that can deliver multiple doses of a vaccine over an extended length of time with just one injection. The particles, made from a biocompatible, FDA-approved polymer, look like tiny coffee cups that can be filled with a drug and sealed. The polymer […]