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This company helps cell therapies travel around the world
With Gilead Sciences (NSDQ:GILD) and Novartis (NYSE:NVS) leading the way, cell therapies are moving on to the market and into the clinics for patients that have no other option. Companies making CAR-T...
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Surmodics goes head-to-head with Medtronic’s drug-coated balloon in pivotal...
Surmodics (NSDQ:SRDX) announced today that the first patient was enrolled in a pivotal clinical trial evaluating its SurVeil drug-coated balloon. The 446-patient trial is designed to compare the...
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FDA clears AstraZeneca’s once-weekly Type II diabetes drug-device combo
AstraZeneca (NYSE:AZN) said today that the FDA approved its once-weekly exenatide drug in a single-dose auto-injector for adults with Type II diabetes whose blood sugar is uncontrolled on one or more...
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United Therapeutics wins FDA nod for third-gen Tyvaso TD-300/A nebulizer
United Therapeutics (NSDQ:UTHR) said today that its third-generation inhalation device designed for use with its Tyvaso treprostinil inhalation solution won FDA approval. Tyvaso first won FDA approval...
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Cerveau inks licensing deal with AbbVie for tau imaging agent
Cerveau Technologies has inked a deal to license and supply AbbVie (NYSE:ABBV) with its [F-18]MK-6240 investigational tau imaging agent, the company said today. After the FDA cleared the...
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Ypsomed to supply Bigfoot with insulin infusion sets for pivotal trial
Ypsomed plans to supply Bigfoot Biomedical with a modified version of its Orbit infusion set for the pivotal trial of Bigfoot’s automated insulin delivery system, the companies said today. Ypsomed’s...
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Catalent reorganizes after closing Pharmica purchase
Cook Group said today that it completed the sale of Cook Pharmica to Catalent (NYSE:CTLT). Catalent announced last month that it planned to dish out $950 million to buy the biologics contract...
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JDRF wants to expand access to DIY diabetes tech – here’s how
As companies race to develop the first fully-automated insulin delivery system, a group of tech-savvy patients are hacking their own artificial pancreas systems. And industry is just starting to take...
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Sanofi files patent infringement suit against Mylan over insulin pen
Sanofi (NYSE:SNY) filed a patent infringement suit against Mylan (NSDQ:MYL) yesterday in the U.S. District Court of New Jersey, alleging that the EpiPen-maker infringed upon 18 patents covering...
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Tandem looks to get in on ex-Animas customer base
Tandem Diabetes Care (NSDQ:TNDM) and Dexcom (NSDQ:DXCM) announced yesterday that the companies would extend their existing joint welcome program aimed at luring Animas customers as Johnson &...
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United Therapeutics beats sales, earnings estimates in Q3
Shares in United Therapeutics (NSDQ:UTHR) rose today after the biotech beat expectations on Wall Street with its third quarter results. The Silver Spring, Md.-based company posted profits of $267.3...
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Pacira to invest up to $25m in surgical reconstruction company
Pacira Pharmaceuticals (NSDQ:PCRX) plans to invest up to $25 million in privately-held surgical reconstruction company Tela Bio, the company said today. Pennsylvania-based Tela Bio has a portfolio of...
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FDA clears expansion of CeloNova’s nano-coated coronary stent trial
CeloNova Biosciences said today that the FDA approved an expansion of the on-going clinical trial for its Cobra PzF nano-coated coronary stent with 14-day dual antiplatelet therapy in complex patients,...
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West Pharma posts Street-beating Q3 earnings, sales
Shares in West Pharmaceutical Services (NYSE:WST) rose today after the company beat expectations on Wall Street with its third quarter results. The Exton, Penn.-based company posted profits of $51...
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The top 10 medical disruptors of 2018
[Image from unsplash.com]Each year the Cleveland Clinic determines what the top 10 disruptors in healthcare will be for the following year. The criteria to be considered a disruptor or innovation is...
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Meet 5 companies developing novel drug-delivery devices
At the 7th annual Partnership Opportunities in Drug Delivery event, presented by The Conference Forum, device companies gathered to tout their drug-delivery technologies and learn from each other’s...
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Medinol wins CE Mark for EluNir drug-eluting coronary stent system
Medinol said today that it won CE Mark clearance for its EluNir drug-eluting stent – a device designed with a low metal footprint and a elastomeric coating. In one 958-patient clinical study, the...
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Merck raises full-year guidance despite mixed Q3
Shares in Merck (NYSE:MRK) slipped in pre-market activity today after the pharmaceutical company beat earnings estimates but missed sales expectations on Wall Street with its third quarter results. The...
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Tandem reels in losses but misses revenue estimates in Q3
Shares in Tandem Diabetes Care (NSDQ:TNDM) rose today after the medical device maker reeled in its losses but missed sales estimates on Wall Street with its third quarter results. The San Diego,...
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Trump’s opioid public health emergency highlights differences with FDA
President Donald Trump yesterday declared the opioid epidemic a national public health emergency – a move that he said will help “liberate our communities from this scourge of drug addiction.” The...
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