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MannKind shares dip after Q1 sales miss consensus
Shares in MannKind Corp. (NSDQ:MNKD) fell this week after the biopharmaceutical company missed expectations on Wall Street with its 1st quarter results. The Valencia, Calif.-based company pared its...
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Genoa raises $62m Series A for inhaled lung drug
Genoa Pharmaceuticals said today that it raised $62 million in a Series A round to support the development of inhaled therapies for idiopathic pulmonary fibrosis and other severe pulmonary conditions....
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Aptar Pharma’s nasal spray compliance device wins EMA nod
Aptar Pharma said today that the European Medicines Agency approved its electronic nasal lockout device, e-Lockout. The device is the 1st and only fully-integrated electronic nasal drug delivery device...
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Trump considers drug-pricing reform with input from industry groups, advocates
President Donald Trump’s administration took aim at drug-pricing reform this month by holding listening sessions with industry groups and advocates. His administration is pursuing actions it can take...
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Nano-drug hitchhikes on white blood cells directly to tumor site
Researchers from Washington State University have developed a way to target drug delivery to a tumor by attaching the therapeutic to white blood cells. The discovery, which the team describes as a 1st...
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Study: Rivanna’s anesthesia placement device boosts accuracy, efficacy
Rivanna Medical touted data from 3 trials today showing that its Accuro automatic spinal navigation system boosts the accuracy of epidural and spinal anesthesia placement compared to traditional...
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Novelion CEO leaves Nordisk board due to potential conflict of interest |...
Novo Nordisk (NYSE:NVO) said this week that the CEO of Canadian biotech Novelion Therapeutics, Mary Szela, left Nordisk’s board effective immediately due to a “potential conflict of interest”. Szela’s...
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Powering the next generation of ingestible drug delivery devices
Traditional implants in the gastrointestinal tract are meant to pass through a patient’s system, delivering a drug in short bursts or recording the health of a patient’s colon. But in recent years,...
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Alucent wins FDA nod for trial of novel drug-device PVD treatment
Alucent Medical said today that it won FDA approval to begin Phase I clinical studies of its Natural Vascular Scaffolding, a novel combination drug-device therapy for the treatment of peripheral...
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EuroPCR Roundup: Medtronic’s Resolute Onyx meets primary endpoint in...
Medtronic‘s (NYSE:MDT) Resolute Onyx 2.0mm drug-eluting stent met its primary endpoint of target lesion failure at 1 year for the treatment of coronary artery disease in extra-small vessels, according...
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Navigating the regulatory and development pathways for drug-device products
David Lee began his path to CEO of Lumicell in 1999, when his wife was diagnosed with cancer. She passed away in 2003, while Lee was working in the semiconductor industry. He decided it was time for a...
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HHS chief Price: Cut FDA’s budget and hike user fees
Secretary of Health and Human Services Tom Price penned a letter to Sen. Patty Murray (D-Wash.) asking the Senate Health, Education, Labor & Pensions committee to consider increasing user fees that...
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New FDA commish extends time for comments on off-label communication rules
Under the agency’s new commissioner, Dr. Scott Gottlieb, the FDA has reportedly extended the time for comments in its review of off-label communication rules. In the past, Gottlieb has advocated for...
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Teva to cut 500 jobs after closing Hungary facility
Teva Pharmaceutical (NYSE:TEVA) is reportedly closing its sterile injectables plant in Godollo, Hungray and 500 workers could lose their jobs. The generics-maker is slated to close or sell the facility...
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Sanofi’s insulin biosimilar wins EMA committee recommendation
Sanofi (NYSE:SNY) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended its insulin lispro biosimilar for approval. Insulin lispro Sanofi is a...
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Quvium’s cough monitor boosts compliance by involving caregivers
When Steven Schmidt worked at Vertex Pharmaceuticals (NSDQ:VRTX), Eric Olson – the man who led the development of the 1st drug to treat the underlying causes of cystic fibrosis – asked Schmidt to look...
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Triple-combo inhaler for COPD wins recommendation for approval in EU
Chiesi Group said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the EMA approve its extra-fine triple combination inhaler for the treatment...
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Intersect ENT updates on Sinuva steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) said today that the FDA is slated to make a decision on its new drug application for the Sinuva steroid-releasing sinus implant by January 7, 2018. The Sinuva implant, which...
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Anika touts Phase III data for Cingal knee therapy
Anika Therapeutics (NSDQ:ANIK) touted data today from a Phase III trial for its Cingal hyaluronic acid-corticosteroid combination viscosupplement as a treatment for osteoarthritis-related knee pain....
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Proteus, Otsuka take another run at FDA approval for Abilify-smart pill combo
Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health said today that the FDA accepted its resubmitted new drug application for their “smart pill”. The drug-device product combines Abilify and a...
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