Guided Therapeutics (OTC:GTHP) said that it inked an exclusive licensing agreement with Shandong Yaohua Medical Instrument Corp., to manufacture its LuViva advanced cervical scan system and related disposables. The deal also gives SMI exclusive distribution rights in China, Macau, Hong Kong and Taiwan. SMI is slated to pay a $1.0 million licensing fee in 5 installments until […]
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Organogenesis launches PuraPly antimicrobial clinical program
Organogenesis said today that it launched its PuraPly Antimicrobial clinical research program, which will evaluate patients treated with PuraPly AM for up to 12 weeks. The 1st studies have started enrolling patients, according to Organogenesis. The Canton, Mass.-based company’s PuraPly AM is a 510(k)-cleared device indicated for the management of acute and chronic wounds. The […]
Cardiologist Dr. Kereiakes: the Synergy bioabsorbable stent boasts flexibility & safety
Dr. Dean Kereiakes knows a thing or 2 about coronary stents – he’s been a principal investigator in a number of clinical trials evaluating coronary stents over the past 20 years. So it counts when Kereiakes names the Synergy stent made by Boston Scientific‘s (NYSE:BSX) “the safest stent yet.” An interventional cardiologist at the Christ Hospital, he was also a […]
Value-based healthcare: Evolent, Advisory Board mull merger
Evolent Health (NYSE:EVH) and the Advisory Board Co. (NSDQ:ABCO), which helped launch Evolent in 2011, are contemplating a merger, “people familiar with the matter” told Reuters. Evolent, which makes software for hospitals moving from fee-for-service to an outcomes-based business model, was founded in 2011 by its top 2 investors, the University of Pittsburgh Medical Center Advisory Board Co., a healthcare research firm. […]
Alere gains on judge’s dissent in different case
Shares in Alere (NYSE:ALR) closed up more than 3% last week as investors reportedly reacted to a Delaware state judge’s dissent in an unrelated case. Investors in the diagnostics giant, which is fighting an attempt by Abbott (NYSE:ABT) to spike their $6 billion merger, viewed a dissenting opinion in a case involving a different deal as a good sign. In that […]
CMS updates on criteria for Dexcom G5 coverage
Shares in DexCom Inc. (NSDQ:DXCM) jumped 9% today after the Centers for Medicare & Medicaid Services updated the criteria for coverage of the company’s G5 Mobile continuous glucose monitor. The device is the only therapeutic CGM classified as durable medical equipment under Medicare Part B. Patients covered by Medicare who have Type I or II diabetes and […]
Lilly details plans for $850m investment in U.S. operations
Eli Lilly (NYSE:LLY) said today that it plans to invest $850 million in its U.S. operations in 2017. The company presented details of its plans at the Lilly Technology Center in Indianapolis, joined by federal, state and local government officials. Lilly said it will invest in an $85 million expansion of its Trulicity device assembly […]
European advisory committee backs label update for Nordisk’s Tresiba
Shares in Novo Nordisk (NYSE:NVO) were up 2% this morning after the European Medicines Agency’s Committee for Medicinal Products for Human Use backed the company’s application for a label update to its Tresiba insulin injection. The company submitted an application in November to add data from 2 studies to the medication’s label. The final ruling is expected […]
Abbott divests 60% of its stake in Mylan
Abbott (NYSE:ABT) divested 60% of its remaining stake in Mylan (NSDQ:MYL) this week, according to regulatory filings, disposing of 44 million shares at $41.60 apiece. The trade was valued at $1.7 billion. In 2014, Mylan bought Abbott’s generics business outside the U.S. in a deal that rang in at nearly $5.3 billion. The deal allowed Canonsburg, Penn.-based Mylan […]
Gamida Cell wins additional EMA orphan drug designation for NiCord
Gamida Cell said today that the European Medicines Agency granted its NiCord cell graft an additional orphan drug designation as a treatment for hematopoietic stem cell transplantation, or bone marrow transplantation. The treatment is a graft derived from umbilical cord blood which has been expanded and enriched with stem and progenitor cells, according to the […]
Intact Vascular finishes patient enrollment for angioplasty clinical trial
Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee. The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, […]