August 2012
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Mylan has announced that it received a complete response letter from the FDA in regards to its ANDA for a generic version of GlaxoSmithKline’s Advair Diskus fluticasone/salmeterol DPI. The company said that it is reviewing… Read more . . .
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Glenmark Pharmaceuticals says that data from a Phase 3 study of its GSP 301 mometasone furoate/olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis show statistically significant and clinically meaningful improvement in symptoms… Read more . . .
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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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