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After 20 years, Paratek’s broad-spectrum antibiotic is headed to the FDA
More than two decades after it was first synthesized in a lab, omadacycline is finally being reviewed by the FDA for its potential as a broad-spectrum antibiotic. It’s a long-awaited milestone for Dr....
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Acorda posts Q4 revenue beat, but misses EPS estimates
Shares in Acorda Therapeutics (NSDQ:ACOR) fell today after the biotech company met sales expectations on Wall Street with its fourth-quarter results, but missed EPS estimates. The Ardsley, N.Y.-based...
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Medtronic looks to expand MiniMed 670G into pediatric diabetes
Medtronic (NYSE:MDT) touted data today from an at-home pediatric study of its MiniMed 670G hybrid closed-loop diabetes management system. The company’s study included 105 kids, ages 7 to 13, and found...
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Tandem Diabetes touts pivotal study of insulin pump with low glucose suspend...
Tandem Diabetes Care (NSDQ:TNDM) touted data today from a pivotal study of its t:slim X2 insulin pump, which features a predictive low glucose suspend feature called Basal-IQ. The study showed that the...
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With weeks left in flu season, the FDA is already working on next year’s vaccine
Photo credit: USACE There are still weeks left in this year’s flu season, according to the FDA, but the agency is already planning on how to better protect the nation’s public health next year. An...
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Tandem inks distribution deal in Scandinavia for insulin pumps
Tandem Diabetes Care (NSDQ:TNDM) has inked a distribution agreement with Rubin Medical to commercialize the medical device company’s t:slim X2 insulin pump, insulin cartridges and t:lock infusion sets...
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FDA issues warning for Roche’s Accu-Chek diabetes management app
The FDA today issued a Class 2 device recall for Roche‘s (OTC:RHHBY) Accu-Chek connected diabetes management app. The company first notified the regulatory agency of the software bug in June last year....
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Pacira shares fall after FDA committee rejects expanded use for Exparel pain...
Shares in Pacira Pharmaceuticals (NSDQ:PCRX) fell nearly -16% today after a panel of experts convened by the FDA voted against an expanded use for Pacira’s injectable pain drug. The pharmaceutical...
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Tandem Diabetes bids for Health Canada nod
Tandem Diabetes Care (NSDQ:TNDM) has submitted a medical device license application to Health Canada in the hopes of launching its t:slim X2 insulin pump in Canada in the second half of this year. The...
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Medtronic expands insulin pump portfolio with MiniMed Mio infusion set
Medtronic (NYSE:MDT) has launched its MiniMed Mio Advance infusion sets, which are designed for people managing their diabetes with insulin pump therapy. The medtech titan touted its product, which was...
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Pieris Pharmaceuticals closes $51m public offering
Pieris Pharmaceuticals (NSDQ:PIRS) has closed an underwritten public offering of 6,325,000 shares of its common stock. The Boston, Mass.-based company said it reeled in $50.6 million from the offering,...
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Express Scripts to include Novo Nordisk’s once-weekly diabetes drug on 2018...
Express Scripts, one of the nation’s largest pharmacy benefit managers, reportedly plans to include Novo Nordisk‘s (NYSE:NVO) once-weekly Type II diabetes, Ozempic, on its 2018 formulary. The move puts...
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Novocure misses Q4 EPS by a penny, tops sales estimates
Shares in Novocure (NSDQ:NVCR) rose slightly today in premarket activity after the medical device maker met sales expectations, but missed earnings estimates on Wall Street with its fourth quarter and...
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Insulet beats the Street with Q4, FY17 sales
Insulet (NSDQ:PODD) reported yesterday that the insulin delivery device-maker topped sales expectations on Wall Street for its fourth quarter and full-year financial results, but missed earnings...
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Anika posts mixed Q4, FY17 results
Shares in Anika Therapeutics (NSDQ:ANIK) rose today after the company topped earnings expectations on Wall Street with its fourth quarter and full-year financial results, but missed sales estimates....
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Valeritas inks distribution deal in Italy for V-Go insulin delivery device
Valeritas (NSDQ:VLRX) has inked an exclusive distribution deal with Movi SpA for the commercialization of its V-Go wearable insulin delivery device in Italy. According to the terms of the deal, Movi...
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Needle-free flu vaccine will be back in clinics next flu season
MedImmune‘s FluMist, the only needle-free flu vaccine available in the U.S., has regained the support of an expert panel at the Centers for Disease Control & Prevention. The Advisory Committee on...
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Novo Nordisk touts promising results from late-stage trial of oral diabetes med
Setting the stage for a battle with rival Eli Lilly (NYSE:LLY), Novo Nordisk (NYSE:NVO) reported data this week from a late-stage trial of its oral formulation of semaglutide, a medication for people...
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Medtronic wins sensor nod from FDA for MiniMed 670G auto insulin tech
The FDA has cleared Medtronic‘s (NYSE:MDT) Guardian sensor, part of the medtech titan’s MiniMed 670G automated insulin delivery system, to be worn on the upper arm. The device is Medtronic’s newest and...
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Reva Medical wins CE Mark for bioresorbable Fantom Encore scaffold
Reva Medical (ASX:RVA) has won CE Mark clearance for its thin strut Fantom Encore bioresorbable, drug-eluting scaffold. The sirolimus-eluting vascular scaffold, which is made from Reva’s Tyrocore...
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