News
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The FDA has denied a citizen petition filed by Sandoz in October 2016 in which Sandoz challenged the agency’s 2013 bioequivalence recommendations for generic versions of Advair Diskus fluticasone propionate/salmeterol xinafoate. However, in a copy… Read more . . .
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Lupin announced that the FDA has granted final approval for the company’s tobramycin inhalation solution, a generic version of Novartis’s TOBI 300 mg/5 ml inhalation solution for the treatment of P. aeruginosa lung infections in… Read more . . .
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Opiant Pharmaceuticals (formerly Lightlake Therapeutics) has announced the initiation of a Phase 2 trial of its OPNT001 intranasal naloxone for the treatment of bulimia nervosa. In 2014, the company licensed its Narcan intranasal naloxone for… Read more . . .
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The Monash University Institute of Pharmaceutical Sciences (MIPS) has announced positive results from a Phase 1 study of inhaled oxytocin in healthy volunteers. The study was conducted by GSK, which is partnered with Monash University… Read more . . .
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According to PARI Pharma, the company has licensed a formulation of liposomal cyclosporine A for the treatment of bronchiolitis obliterans syndrome (BOS) to Breath Therapeutics. Breath Therapeutics, a spin off of PARI, recently announced that… Read more . . .
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AstraZeneca has announced an agreement with Circassia Pharmaceuticals for development and commercialization of the Tudorza and Duaklir dry powder inhalers in the US. AstraZeneca will receive $50 million in Circassia ordinary shares and $100 million… Read more . . .
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Connected health company Cohero Health has added $1.5 million from new investors Samsung NEXT and Omron Healthcare to its Series A round, the company said. In November 2016, Cohero announced closure of the $9 million… Read more . . .
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US-based MedInvent has obtained CE Marking and ISO 13485 and CMDCAS certification for its NasoNeb II nasal nebulizer, the company said. The company has also signed a distribution contract with Vedise Hospital in Rome, Italy,… Read more . . .
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The Medicon Valley Inhalation Consortium (MVIC) has announced that Lars Asking, who has served as VP of MVIC since May 2016, will become CEO of the consortium as of May 2017. Asking will take over… Read more . . .
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A February 17, 2017 FDA warning letter to Wockhardt subsidiary Morton Grove Pharmaceuticals cites numerous cGMP violations, including several related to the manufacture of fluticasone propionate nasal spray. Wockhardt’s generic fluticasone propionate nasal spray was… Read more . . .
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