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Controlled-release ADHD drug wins FDA approval
Neos Therapeutics (NSDQ:NEOS) won FDA approval yesterday for its controlled-release formulation of an old ADHD drug, methylphenidate. The company touts its product, Cotempla XR-ODT, as the 1st...
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Pamplona Capital to acquire Parexel in $5B deal
Parexel said today that it would go private after Pamplona Capital agreed to buy the pharmaceutical research services company in a deal valued at $5 billion. Pamplona is slated to pay $88.10 per share...
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Rubius snags $120m for red blood cell therapeutics
Rubius Therapeutics, a biotech engineering red blood cells as drug carriers, said today that it raised $120 million in an oversubscribed private financing round. The Cambridge, Mass.-based company...
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Glaukos touts iStent study with topical travoprost
Glaukos (NYSE:GKOS) touted data today from a 53-patient glaucoma study showing that its iStent device combined with topical travoprost reduced mean intraocular pressure by 35% after 18 months of...
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Novartis trial results could spell trouble for Regeneron
Head-to-head late-stage clinical trials published on Tuesday showed that a Novartis (NYSE:NVS) drug to treat patients with neovascular age-related macular degeneration doesn’t need to be injected as...
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Cleveland Clinic spinout Infuseon inks deal with OncoSynergy
Infuseon Therapeutics inked a deal this week with OncoSynergy to evaluate a glioblastoma therapeutic with the Cleveland Clinic spinout’s novel delivery device. The alliance hopes to demonstrate...
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Another extended-release ADHD drug wins FDA nod
Days after Neos Therapeutics (NSDQ:NEOS) nabbed U.S. regulatory approval for its controlled-release formulation of methylphenidate, Shire (NSDQ:SHPG) said it won a nod from the FDA for its long-acting...
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TriReme Medical touts Chocolate Heart drug-coated balloon data
QT Vascular subsidiary TriReme Medical touted angiographic data today from a 24-month follow-up of patients treated with its Chocolate Heart drug-coated balloon. The Chocolate Heart device is a...
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pSivida seeks European regulatory nod for Durasert
pSivida (NSDQ:PSDV) is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing authorization...
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FDA committee supports Nordisk’s cardiovascular risk claim for Victoza label
Novo Nordisk (NYSE:NVO) shares ticked up 1% earlier this week after an advisory committee for the FDA voted to recommend that the company’s cardiovascular risk reduction claim be added to its Victoza...
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Mylan shareholders vote against executive pay package, but re-elect board
At the company’s annual meeting, Mylan (NSDQ:MYL) shareholders re-elected the drugmaker’s board despite a campaign spearheaded by major investors to do otherwise. The campaign hoped to encourage...
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Indivior touts late-stage trial for monthly buprenorphine depot
Indivior (LON:INDV) touted data today from its pivotal Phase III trial for RBP-6000, a once-monthly injectable buprenorphine depot for the treatment of adults with opioid use disorder. The 24-week...
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Medtronic warns on button glitch with MiniMed 640G insulin pump
Medtronic (NYSE:MDT) issued a field safety notice in May, warning users that keypad buttons on its MiniMed 640G insulin pump may become temporarily stuck when the atmospheric pressure around the pump...
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Ocular Therapeutix founder & CEO Sawhney to step down | Personnel Moves –...
The president & CEO of Ocular Therapeutix (NSDQ:OCUL), Amarpreet Sawhney, is slated to step down from the company that he helped start in 2006. He will serve as the board’s executive chairman for 1...
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Nanobiotix seeks to boost cancer care with nanoparticle-radiotherapy combo
Increasingly, pharma and biotech companies are looking towards personalized medicine to guide their portfolios, developing therapies designed to address the needs of individual patient populations....
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BioDelivery wins Health Canada approval for Belbuca pain relief product
BioDelivery Sciences International (NSDQ:BDSI) said today that Health Canada approved its buprenorphine hydrochloride buccal film, Belbuca, for the management of pain severe enough to necessitate...
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FDA approves diagnostic that simultaneously screens for multiple lung cancer...
The FDA said today that it awarded premarket approval to Thermo Fisher Scientific’s (NYSE:TMO) next-gen sequencing-based test that can simultaneously screen tumor samples for biomarkers associated with...
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Camarus, Braeburn tout Phase II data for long-acting buprenorphine depot
Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals touted data yesterday from a Phase II trial of its long-acting buprenorphine depot. The 47-patient trial found that CAM2038 blocks the effects of...
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Tiny bubbles get past blood-brain barrier for targeted drug delivery
The blood-brain barrier plays an important role in protecting the human brain from harmful toxins. But it also stops potentially helpful drugs from reaching the brain. Now, researchers believe that...
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Semnur touts Phase I/II trial of non-opioid pain-killer
Semnur Pharmaceuticals touted data today from a Phase I/II pharmacokinetic trial of its injectable, non-opioid pain-killer, SP-102. The trial enrolled 12 patients with radicular pain. The trial met its...
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