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Sarah Faulkner

Teva launches breath-activated asthma aerosol in U.S.

February 12, 2018 By Sarah Faulkner

Teva's Qvar RediHaler

Teva Pharmaceuticals (NYSE:TEVA) has launched its Qvar RediHaler inhalation aerosol in the U.S., marking the first time a breath-actuated inhaled corticosteroid is available for asthma patients as a prophylactic therapy. In contrast to traditional metered-dose inhalers, Teva’s Qvar RediHaler sends medication into the user’s lungs as they inhale. This feature eliminates the need for hand-breath coordination, […]

Filed Under: Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: Teva Pharmaceuticals

Icon Bioscience wins FDA nod for long-acting cataract surgery drug

February 12, 2018 By Sarah Faulkner

Icon Bioscience

Icon Bioscience said today that the FDA has approved its application for Dexycu, a long-acting therapy designed to treat inflammation in patients who have had cataract surgery. More than four million cataract surgeries are performed each year in the U.S., according to the privately-held biopharma company, and most patients treat inflammation in their eyes using […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance, Surgical Tagged With: iconbioscience

Insulet settles investor suit for $20m

February 12, 2018 By Sarah Faulkner

Insulet Omnipod

Insulet (NSDQ:PODD) plans to fork over $19.5 million to settle a class action lawsuit brought by the Arkansas Teacher Retirement System, the City of Bristol Pension Fund and the City of Omaha Police and Fire Retirement System, according to court documents. The lawsuit alleged that Insulet misrepresented the success of its OmniPod Eros roll-out in 2013, which eventually […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Legal News, Pharmaceuticals, Wall Street Beat Tagged With: Insulet

Rebiotix develops tool to measure rehabilitation of microbiome

February 12, 2018 By Sarah Faulkner

Rebiotix

Rebiotix today unveiled its Microbiome Health Index – a tool it created to establish a standard metric that can be used to quantify how effective a microbiome-based therapy is at rehabilitating the human microbiome. The index, which was developed in partnership with data analytics firm BioRankings, combines four bacterial classes into a unidimensional expression of […]

Filed Under: Big Data, Clinical Trials, Discovery, Featured, Pharmaceuticals Tagged With: rebiotix

DarioHealth inks deal to use blood glucose tech in pharma company’s clinical trial

February 9, 2018 By Sarah Faulkner

DarioHealth

DarioHealth (NSDQ:DRIO) said today that it inked a deal with an unnamed pharmaceutical company to combine its blood glucose monitoring tech into the company’s clinical trial. The Israel-based device-maker reported that this pharmaceutical company is conducting a trial of its diabetes drug that will eventually be included in a regulatory package for FDA approval. DarioHealth has […]

Filed Under: Clinical Trials, Diabetes, Featured, Patient Monitoring, Pharmaceuticals, Wall Street Beat Tagged With: dariohealth

Veryan’s helical stent meets safety, efficacy endpoints after 12 months

February 9, 2018 By Sarah Faulkner

Veryan Biomimics

Veryan‘s helical BioMimics 3D stent met its primary safety and efficacy endpoints in a study of 271 patients with symptomatic femoropopliteal artery disease, according to TCTMD. The device, which is shaped to mimic the natural geometry of human vasculature, compared favorably with drug-coated balloons and stents. The probability of maintaining primary patency after 12 months was […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Vascular, Wall Street Beat Tagged With: C.R. Bard, cook medical, Medtronic, Spectranetics, veryan

Congress doles out $300m to fund diabetes research

February 9, 2018 By Sarah Faulkner

capitol hill

Congress today approved a two-year extension of the Special Diabetes Program, giving the National Institutes of Health $300 million to fund research into new therapies and technologies for people with Type I diabetes. The program, which has historically garnered bipartisan support, was last reauthorized in 2015 when lawmakers budgeted $150 million over two years for […]

Filed Under: Diabetes, Featured, Pharmaceuticals, Research & Development Tagged With: Juvenile Diabetes Research Foundation (JDRF), National Institutes of Health

Innoviva posts Street-beating Q4, FY17 earnings

February 9, 2018 By Sarah Faulkner

Innoviva

Shares in Innoviva (NSDQ:INVA) rose today after the company topped expectations on Wall Street with its fourth quarter and full-year financial results. The Brisbane, Calif.-based company posted profits of $58.4 million, or 55¢ per share, on sales of $69.5 million for the 3 months ended Dec. 31, for bottom-line growth of 129% on sales growth of […]

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

Tandem Diabetes Care prices $60m offering

February 9, 2018 By Sarah Faulkner

Tandem Diabetes

Tandem Diabetes Care (NSDQ:TNDM) has priced an underwritten public offering of 30 million shares of common stock at $2.00 apiece. The San Diego, Calif.-based company said it expects to reel in $60 million from the offering. Tandem also gave underwriters a 30-day option to buy up to 4.5 million more shares of common stock. The offering […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Funding Roundup, Wall Street Beat Tagged With: Tandem Diabetes Care

Novo Nordisk’s once-weekly Type II diabetes med approved in Europe

February 9, 2018 By Sarah Faulkner

Novo Nordisk

The European Commission has approved Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide drug, Ozempic, as a treatment for adults with Type II diabetes. The GLP-1 analogue’s label in Europe recommends that the drug is given when metformin is contraindicated or not tolerated, Novo Nordisk reported today. The E.U. agency approved Ozempic for use in a multi-dose pre-filled pen, but […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Novo Nordisk

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