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FDA to review Sunovion’s apomorphine sublingual film for Parkinson’s disease
Sunovion Pharmaceuticals said today that the FDA accepted its new drug application for a sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The U.S....
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Pulmatrix touts Ph1 data for inhaled COPD therapy
Pulmatrix (NSDQ:PULM) touted data today from a dose-ranging Phase I trial of its once-daily inhaled therapy designed for people with chronic obstructive pulmonary disease. The company’s product is a...
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FDA rejects Mylan’s Advair generic in win for GSK
Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic...
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Medtronic wins FDA nod for new lengths of drug-coated balloon
Medtronic (NYSE:MDT) said today that it won FDA approval for 200mm and 250mm lengths of its In.Pact Admiral drug-coated balloon. The newly-approved lengths are designed to treat patients with longer,...
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Insys Therapeutics reports positive preliminary data for allergy nasal spray
Shares in Insys Therapeutics (NSDQ:INSY) jumped yesterday after the company reported positive data for its investigational epinephrine nasal spray designed as a needle-free treatment for anaphylaxis....
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HealthPrize takes aim at medication nonadherence with habit-forming tech
At HealthPrize Technologies, chief executive Tom Kottler is tackling a problem that many in the pharmaceutical industry are trying to solve: What stops people from taking their medications and how can...
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FDA approves first generic sublingual film to treat opioid addiction
The FDA this week approved the first generic version of Indivior‘s (LON:INDV) billion-dollar opioid addiction treatment, Suboxone. The generic buprenorphine and naloxone sublingual film, sold by Dr....
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Verrica Pharmaceuticals prices $75m IPO to fund drug-device skin therapy
Verrica Pharmaceuticals said this week that it plans to offer 5 million shares priced between $14 to $16 apiece, setting its initial public offering at $75 million. The West Chester, PA-based company...
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Foundation Medicine looks to expand oncology arsenal with precision drugs
Before she was Foundation Medicine‘s (NSDQ:FMI) chief business executive, Melanie Nallicheri was as an advisor to an ongoing project at the Cleveland Clinic, where she was witness to the power of...
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Study finds nearly half of people with diabetes skip care due to costs
A newly-published report from UpWell Health found that nearly half of Americans with diabetes have skipped medical care at times because they couldn’t afford it. The 5,000-person survey showed that...
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Reva Medical wins CE Mark for full line of Fantom Encore bioresorbable scaffolds
Reva Medical (ASX:RVA) said this week that it won CE Mark clearance for its entire line of Fantom Encore bioresorbable, drug-eluting scaffolds. The new approval covers Reva’s Fantom 3.0 and 3.5 mm...
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ivWatch to integrate IV infiltration sensor into Philips’ patient monitors
For decades, nurses have sent drugs surging through a patient’s body using the power of the circulatory system. Catheters deliver medications destined to travel through a person’s veins – but it...
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Anika shares plummet after Phase III trial misses endpoint
Shares in Anika Therapeutics (NSDQ:ANIK) fell more than -30% this week after the company reported that its osteoarthritis drug, Cingal, failed in a Phase III trial. The therapy, designed to treat...
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Generic drug shows promise as diabetes vaccine in small, years-long study
A cheap, generic tuberculosis vaccine lowered blood glucose levels in nine patients with Type I diabetes and the effects lasted for years, according to a study published this week in npj Vaccines. The...
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Companion Medical launches data management system for smart insulin pen
Companion Medical launched today Insights by InPen, a diabetes management system that aggregates and analyzes data from Companion’s connected insulin injection pen. The company’s Insights by InPen...
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Cerebral Therapeutics raises $3m for epilepsy drug-device therapy
Cerebral Therapeutics closed a $3 million Series A financing round this week to support the development of its drug-device therapy designed for patients with refractory epilepsy. The Aurora, Co.-based...
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Medtronic’s MiniMed system wins FDA nod for pediatric indication
The FDA this week expanded its approval for Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop diabetes management device to include people ages 7 to 13 with Type I diabetes. The system, which...
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Mercator MedSystems raises $11m in Series D for micro-infusion catheter system
Mercator MedSystems said this week that it raised $11 million in a Series D equity round led by Shenzhen Salubris Pharmaceuticals, with participation from current Mercator investors and other unnamed...
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Tandem wins FDA nod for insulin pump with predictive low glucose suspend feature
The FDA this week approved Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump with a predictive low glucose suspend feature designed to cut the frequency and duration of hypoglycemia. The San...
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Impel NeuroPharma readies trial for intranasal drug-device migraine treatment
Impel NeuroPharma said today that the FDA gave it the green light to proceed with its Phase III clinical trial of INP104 – a drug delivered by Impel’s intranasal delivery device for the treatment of...
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