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Mass. Supremes: Pharma Cos. liable for generic labeling issues
Merck (NYSE:MRK) and other large brand-name pharmaceutical manufacturers could be legally liable for injuries resulting not from the use of their brand name products, but from generic versions of...
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Tribe looks to stop patent board’s review of Restasis IP
Allergan (NYSE:AGN) and the St. Regis Mohawk Tribe asked the Federal Circuit last week to stop the U.S. Patent Trial and Appeal Board from reviewing the IP for Allergan’s blockbuster eye drug,...
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Trump touts Adapt Pharma’s plan to distribute free opioid-overdose devices to...
In a wide-ranging speech yesterday detailing his administration’s plan to tackle the opioid crisis in the U.S., President Trump touted Adapt Pharma‘s move to distribute free doses of its...
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FDA to review pSivida’s ocular drug-delivery system
pSivida (NSDQ:PSDV) said yesterday that the FDA plans to review the company’s application for its drug-releasing ocular insert, Durasert. The product is designed to provide three years of treatment for...
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Mass. Eye & Ear makes history with first gene therapy procedure for inherited...
Photo courtesy of Mass. Eye & Ear Massachusetts Eye and Ear Infirmary made history this week, becoming the first institution to use an FDA-approved gene therapy to treat a patient with an inherited...
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GlycoMimetics prices $119m public offering
GlycoMimetics (NSDQ:GLYC) priced an underwritten public offering of 7,000,000 shares of common stock at $17.00 apiece today, reporting that it expects to bring in $119 million from the offering. The...
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Novartis, Harvard team up to develop immunotherapy drug-delivery systems
Novartis (NYSE:NVS), Harvard University and the Dana-Farber Cancer Institute are teaming up to develop the next generation of implantable and injectable biomaterials designed to delivery...
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Genentech’s pre-filled syringe for diabetic retinopathy wins FDA nod
Roche‘s (OTC:RHHBY) Genentech announced today that the FDA approved its 0.3-mg pre-filled syringe as a new way to administer Lucentis to diabetic retinopathy patients. The company’s drug is the only...
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Piedmont Healthcare expands use of Glytec’s insulin dosing decision software
Piedmont Healthcare, which uses Glytec‘s insulin therapy tech at three of its hospitals, plans to expand use of the eGlycemic Management System to all of its acute care facilities. Glytec’s software...
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Japan approves Novo Nordisk’s once-weekly Type II diabetes drug
The Japanese Ministry of Health, Labor and Welfare gave Novo Nordisk (NYSE:NVO) the green light to market its once-weekly type II diabetes drug, Ozempic, Reuters reported today. The pharma company’s...
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EU committee backs dosing changes for Bristol-Myers Squibb’s immunotherapy
A committee for the European Union’s pharmaceutical regulatory agency backed changes to the dosing schedule for Bristol-Myers Squibb‘s (NYSE:BMY) Opdivo cancer drug, the company touted today. The...
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Acorda seeks EU approval for inhaled Parkinson’s disease drug
Acorda Therapeutics (NSDQ:ACOR) submitted a marketing authorization application to the European Medicines Agency for its inhaled Parkinson’s disease therapy, Inbrija, according to the Ardsley,...
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FDA approves label update to Novo Nordisk’s Tresiba diabetes drug
The FDA approved Novo Nordisk‘s (NYSE:NVO) request to include heart health data on the label of its Tresiba insulin degludec product. The Danish insulin-maker evaluated its Type II diabetes drug in a...
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This new technology could help surgeons clear out leftover cancer cells
In some instances, as many as 30% of patients need repeat surgeries get rid of cancerous cells initially left behind. The team from Lumicell wants to change that — and improve outcomes for cancer...
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Sanofi’s high-capacity insulin pen wins FDA nod
Sanofi (NYSE:SNY) reported today that its Toujeo Max SoloStar high-capacity insulin pen won FDA approval and will be available in the third quarter of this year. The new device holds 900 units of...
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Milestone Scientific wins Health Canada license for epidural drug-delivery...
Health Canada issued a medical device license to Milestone Scientific (NYSE:MLSS) this week for the company’s CompuFlo Epidural computer-controlled anesthesia system. The Livingston, N.J.-based company...
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Convexity Scientific launches pocket-sized nebulizer
Convexity Scientific announced today that the company launched its Flyp nebulizer for patients with asthma and chronic obstructive pulmonary disease. The handheld, pocket-sized device was approved by...
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Reva touts first implant of Fantom Encore bioresorbable scaffold in Switzerland
Reva Medical (ASX:RVA) announced today that the company’s Fantom Encore bioresorbable vascular scaffold was used for the first time in Switzerland. The sirolimus-eluting device, which is made from...
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Bigfoot brings Series B total to $55m with new investment from Abbott
Reeling in an $18 million add-on to the $37 million Series B that it reported last year, Bigfoot Biomedical touted today that it has raised over $90 million in total funding since the Milpitas,...
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pSivida buys Icon Bioscience and rebrands as EyePoint Pharmaceuticals
With the help of $61 million from EW Healthcare Partners and a third-party investor, pSivida (NSDQ:PSDV) announced today that it acquired Icon Bioscience and its FDA-approved dexamethasone intraocular...
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