December 2016
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GlaxoSmithKline has announced that the Australian Therapeutic Goods Administration (TGA) has approved the Incruse Ellipta umeclidinium DPI for the treatment of COPD. Incruse Ellipta was approved in Canada and in Europe in April 2014 and… Read more . . .
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The UK National Health Service Prescription Services has apologized for mistakenly classifying two versions of the Relvar Ellipta fluticasone/vilanterol DPI under the wrong British National Formulary (BNF) code in its database. The two products involved… Read more . . .
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According to Kentucky-based AntiOp, the company has received Fast Track designation from the FDA for its intranasal naloxone for the reversal of opioid overdose. The company is co-developing the unit-dose nasal spray, its only product,… Read more . . .
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ProStrakan, a subsidiary of Kyowa Hakko Kirin, has announced that it will acquire PecFent fentanyl nasal spray manufacturer Archimedes Pharma for £230 million in cash. Archimedes, which is based in Reading, UK, received European marketing… Read more . . .
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Teva has announced that the FDA has accepted its new drug application for an albuterol dry powder inhaler for the treatment of asthma in patients aged 12 and older. In October 2013, Teva indicated that… Read more . . .
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Following the submission by Teva of an ANDA for a generic mometasone furoate nasal spray, Merck has filed suit in the US District Court alleging infringement of US patent 6,127,353. The patent is due to… Read more . . .
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Biotie Therapeutics has decided not to exercise its option to purchase Neurelis and is returning the rights to Neurelis’s lead product, NRL-1 intranasal diazepam for the treatment of epileptic seizures. Biotie paid $1 million for… Read more . . .
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RDD Asia 2014 co-sponsor Aptar Pharma has announced that registration for the meeting is now open. According to the announcement, the organizers expect more than 200 OINDP specialists to attend the first Asian RDD meeting,… Read more . . .
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The US Patent and Trade Office (USPTO) has awarded Aegis Therapeutics US Patent No. 8,772,231 for “dramatically stabilized insulin formulations suitable for metered nasal spray delivery or injection based upon Aegis’ patented Intravail transmucosal absorption… Read more . . .
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According to Lightlake Therapeutics, the company has signed a contract with a manufacturer for commercial production of its intranasal naloxone for the reversal of opioid overdose. In December 2013, the company announced positive initial results… Read more . . .
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