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Sarah Faulkner

Abbott pulls Xience Alpine drug-eluting stent from Indian market

April 27, 2018 By Sarah Faulkner

Abbott

Abbott (NYSE:ABT) reportedly stopped selling its Xience Alpine drug-eluting coronary stent in India this week in response to price caps set by the National Pharmaceutical Pricing Authority. A spokesperson for the healthcare firm said in a statement that Abbott “fulfilled all the requirements to discontinue selling its Xience Alpine drug-eluting stent in India as of April […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: abbott, Boston Scientific, Medtronic

Following first profitable quarter, Vericel’s CEO looks to grow portfolio of autologous cell therapy products

April 26, 2018 By Sarah Faulkner

vericel

In its latest financial results, Cambridge, Mass.-based Vericel (NSDQ:VCEL) saw sales climb 60% for its permanent skin-replacement product, Epicel, designed for patients with severe burns. Sales for its autologous cellular scaffold, Maci, were up 20% following its launch to the commercial market. Vericel’s growing product adoption helped to fuel the company’s first profitable quarter, according to […]

Filed Under: Clinical Trials, Featured, Implants, Regenerative Medicine, Regulatory/Compliance, Wall Street Beat Tagged With: Novartis, Vericel Corp

Baxter beats The Street with Q1 results

April 26, 2018 By Sarah Faulkner

Bax

Shares in Baxter (NYSE:BAX) rose today in pre-market activity after the medical device maker beat expectations on Wall Street with its first-quarter results. The Deerfield, Ill.-based company posted profits of $389 million, or 71¢ per share, on sales of $2.68 billion for the 3 months ended March 31, for bottom-line growth of 43% on sales growth […]

Filed Under: Featured, MassDevice Earnings Roundup, Pharmaceuticals, Wall Street Beat Tagged With: Baxter International

Novocure misses sales, EPS estimates in Q1

April 26, 2018 By Sarah Faulkner

Novocure

Shares in Novocure (NSDQ:NVCR) fell today after the medical device maker missed expectations on Wall Street with its first-quarter results. The St. Helier, N.J.-based company posted a net loss of -$20.7 million, or -23¢ per share, on sales of $52.1 million for the 3 months ended March 31, for bottom-line loss of -14.8% on sales growth […]

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Oncology, Pharmaceuticals, Wall Street Beat Tagged With: NovoCure

Orion inks $200m deal to sell diagnostics unit

April 23, 2018 By Sarah Faulkner

Orion Diagnostica

Orion said today that it plans to sell its Orion Diagnostica division to an investment fund managed by Axcel Management for $200 million. The Finland-based company said its diagnostic unit operates independently from its pharmaceutical business and that the two groups have “material business synergies.” “The sale of the division will allow us to further […]

Filed Under: Diagnostics, Featured, Mergers & Acquisitions Tagged With: orion

FDA approves Medtronic’s drug-coated balloon to treat long superficial femoral artery lesions

April 23, 2018 By Sarah Faulkner

Medtronic

The FDA approved Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon to treat long superficial femoral artery lesions up to 360mm in patients with peripheral artery disease, the medtech giant touted today. In a 227-patient global trial, participants treated with Medtronic’s drug-device combination therapy had a one-year patency rate of 89.1% and a clinically-driven target revascularization rate […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: Medtronic

Fresenius abandons $4.3B Akorn merger, citing data integrity probe

April 23, 2018 By Sarah Faulkner

Akorn

Fresenius (ETR:FRE) is walking away from a $4.3 billion merger with U.S. generic drugmaker, Akorn Inc. (NSDQ:AKRX), citing an investigation that found material breaches of FDA data integrity requirements relating to Akorn’s operations. Fresenius said in a statement that it offered to delay its decision to give Akorn time to compete its own investigation, but Akorn turned […]

Filed Under: Featured, Mergers & Acquisitions, Pharmaceuticals, Wall Street Beat Tagged With: Akorn, Fresenius

FDA approves IDE trial for Urotronic’s drug-coated balloon

April 20, 2018 By Sarah Faulkner

Urotronic

Minneapolis-based Urotronic said this week that the FDA approved an investigational device exemption trial for its Optilume drug-coated balloon catheter, which is designed to treat urethral strictures in men. The 200-patient pivotal trial is slated to start enrolling participants immediately. “Physicians are looking for a technology that is minimally invasive and also curative,” principal investigator […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: urotronic

Curetis launches diagnostic cartridge for urinary tract infection

April 20, 2018 By Sarah Faulkner

Curetis

Curetis said today that it won CE-IVD marking for its Unyvero cartridge designed to diagnose severe urinary tract infections. The cartridge covers 103 diagnostic targets and can detect 88 pathogens, according to Curetis, including a multi-drug-resistant pathogenic fungus that is of particular concern to hospitalized patients with compromised immune systems. Unyvero UTI can also detect […]

Filed Under: Diagnostics, Featured, Pharmaceuticals Tagged With: curetis

Sollis lands $50m for extended-release pain-relief drug

April 20, 2018 By Sarah Faulkner

Sollis Therapeutics closed a $50 million round to support a pivotal trial of its non-opioid pain-reliever, according to Ohio-based translator NeuroTechnology Innovations Translator. Deerfield Management led the funding round and was joined by NIT collaborators, including Medtronic (NYSE:MDT), Cardinal Health and Ohio State University. NIT founded Sollis Therapeutics last year to help facilitate the development and commercialization […]

Filed Under: Featured, Funding Roundup, Pain Management Tagged With: Cardinal Health, Medtronic, sollistherapeutics

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