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FDA rejects Ocular’s Dextenza for a second time
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA rejected its resubmission of a new drug application for Dextenza. This is the second time that Ocular has received the FDA’s dreaded complete...
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First cell and gene therapy for osteoarthritis approved in Korea
Maryland-based TissueGene said today that Invossa, which it touts as the world’s first cell and gene therapy for degenerative arthritis, won approval from the Korea Ministry of Food and Drug Safety....
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Rennova to spin off advanced molecular services biz
Rennova Health (NSDQ:RNVA) said today that it plans to spin off its advanced molecular services division into an independent, publicly-traded company. The spin-off is slated to take place at the end of...
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BioDelivery Sciences, Purdue ink exclusive distribution deal for Belbuca in...
BioDelivery Sciences International (NSDQ:BDSI) said today that it inked an exclusive distribution deal with Purdue Pharma‘s Canada branch for the licensing, distribution, marketing and sale of Belbuca...
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Clearside Biomedical launches Phase II diabetic macular edema trial
Clearside Biomedical (NSDQ:CLSD) said today that it enrolled the first patient in a Phase II clinical trial of CLS-TA in patients with diabetic macular edema. The trial plans to evaluate Clearside’s...
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Synspira’s therapy could boost antibiotics against drug-resistant bacteria in...
Privately-held Synspira touted a study today of its inhaled glycopolymer-based therapeutic with antibiotics as a potential treatment for pulmonary infection caused by the Burkholderia cepacia complex...
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Study: Nanomedicine shuts down cells that drive cancer growth in glioblastoma
Researchers from Northwestern Medicine have developed lipid polymer-based nanoparticles that target key cancer drivers, called brain tumor initiating cells, in a mouse model of glioblastoma brain...
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Milestone Scientific appoints new CEO following FDA nod | Personnel Moves –...
Milestone Scientific (NYSE:MLSS) said this week that it appointed Daniel Goldberger to the company’s corner office. Leonard Osser, who previously served as CEO, is slated to remain on the board and...
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Bigfoot Biomedical taps Abbott to collaborate on automated insulin delivery tech
Abbott (NYSE:ABT) and Bigfoot Biomedical said today that the companies inked a deal to develop and commercialize diabetes management systems. The collaboration will bring together Abbott’s FreeStyle...
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Sunovion divests asthma, allergy tech to Covis Pharma
Sunovion Pharmaceuticals said today that it plans to divest the U.S. market rights for its allergy and asthma products to Covis Pharma, in an effort to narrow its focus to the company’s COPD portfolio....
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Mallinckrodt wins orphan drug status for long-acting muscular dystrophy therapy
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that the FDA granted orphan drug status to its long-acting cosyntropin acetate formulation, MNK-1411, for the treatment of Duchenne muscular...
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MIT researchers fight drug-resistant bacteria with nanoparticles
Credit: Martin Cathrae Scientists from the Massachusetts Institute of Technology are using nanoparticles to tackle drug-resistant bacteria, according to a study published in Advanced Materials....
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Judge rules that Mylan can’t move EpiPen antitrust suit
New Jersey federal judge Freda Wolfson rejected Mylan‘s (NSDQ:MYL) request to move an antitrust lawsuit brought against the EpiPen maker to Kansas. Mylan previously claimed that moving the case to...
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Bigfoot Biomedical’s CEO talks disruption in diabetes management tech
Bigfoot Biomedical is a highly competitive player in medtech’s race to develop an artificial pancreas. The 50-person company has made rapid progress towards developing a smart, automated insulin...
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Mayo Clinic, nference launch startup to leverage AI for drug development
Mayo Clinic and nference today launched a startup, Qrativ, focused on drug development driven by artificial intelligence. The company, backed by a $8.3 million Series A round, plans to combine...
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Ionis-spinout Akcea prices IPO below expected range
Cambridge, Mass.-based Akcea Therapeutics priced its offering of 15.6 million shares at $8 apiece to reach its $125 million IPO target. The company initially priced an offering of 9.6 million shares at...
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Trovagene raises $7m for precision cancer therapies
Trovagene (NSDQ:TROV) said today that it inked a deal with unnamed investors to sell approximately $7.1 million of its common stock. According to the deal, Trovagene plans to sell 6,191,500 shares of...
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AntriaBio raises $13m for injectable, once-weekly insulin
AntriaBio (OTC:ANTB) said today that it closed a $13 million private placement, supported by Aju Pharm, Ildong Pharmaceutical Co. and Medici Investment Co. According to the deal, investors paid $1.00...
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EU antitrust officials charge Teva in ‘pay-for-delay’ deal
Antitrust regulators in the European Union charged Teva Pharmaceuticals (NYSE:TEVA) today, accusing the company of arranging an illegal deal with Cephalon to delay the sale of a cheap generic version...
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Titan Pharmaceuticals partners for long-acting antimalarial implant
Titan Pharmaceuticals (NSDQ:TTNP) this month revealed a collaboration with the Walter Reed Army Institute of Research to evaluate the use of its ProNeura drug-delivery technology for the long-term...
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