Lightlake Therapeutics has announced that it filed an investigational new drug application for its intranasal naloxone therapy for the reversal of opioid overdose. The company also said that it has received additional funding from the National Institute on Drug Abuse (NIDA) for a new clinical trial of the product. Lightlake recently said that it had signed a … [Read more...] about Lightlake files IND for intranasal naloxone, gets additional NIDA funding
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CFD software adds new capabilities useful to OINDP developers
CD-adapco has announced that STAR-CCM+ v9.04, the latest release of its simulation software, includes new physics models useful for development and analysis of various types of OINDPs in addition to offering significantly faster operation. The new version includes parallel meshing, workflow improvements, and optimization capabilities that will allow for "dramatic … [Read more...] about CFD software adds new capabilities useful to OINDP developers
Phase 3 study of triple combination DPI underway
GlaxoSmithKline and Theravance have announced the commencement of a Phase 3 study of a triple combination inhaled therapy delivered using the Ellipta DPI for the treament of COPD. The triple therapy combines fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI). The 52-week study will involve approximately 10,000 patients in 38 countries who will … [Read more...] about Phase 3 study of triple combination DPI underway
Incruse Ellipta approved in Australia
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 in the US in May 2014. GSK Associate Medical Director Navin Singh said, “We are delighted by the TGA approval of Incruse … [Read more...] about Incruse Ellipta approved in Australia
NHS apologizes for mis-coding Relvar Ellipta
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 are 184mcg/22mcg and 92mcg/22mcg dosage strengths of Relvar. According to the NHS Business Services Authority, … [Read more...] about NHS apologizes for mis-coding Relvar Ellipta
AntiOp gets FDA Fast Track designation for its naloxone nasal spray
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, with Reckitt Benckiser and has received approximately $4.5 million in grant funding from the National Institutes of Health and its … [Read more...] about AntiOp gets FDA Fast Track designation for its naloxone nasal spray
ProStrakan to acquire Archimedes Pharma, PecFent nasal spray
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 approval for PecFent in 2011. Archimedes sold its US business and the US version of PecFent, marketed as Lazanda, to Depomed in … [Read more...] about ProStrakan to acquire Archimedes Pharma, PecFent nasal spray
Teva submits NDA for albuterol dry powder inhaler
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 it planned to submit a 505(b)(2) application for ProAir Spiromax by mid-2014. The company is referring to the breath activated multi-dose dry powder inhaler as an … [Read more...] about Teva submits NDA for albuterol dry powder inhaler
Merck sues Teva over mometasone furoate nasal spray
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 expire in October 2017. In June 2012, a US District Court judge upheld the validity of the patent in a suit by Merck against Apotex but ruled that Merck had … [Read more...] about Merck sues Teva over mometasone furoate nasal spray
Biotie returns intranasal diazepam rights to Neurelis
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 the option to purchase Neurelis in June 2013. Under the deal, Biotie will still participate in any future revenues from the product to … [Read more...] about Biotie returns intranasal diazepam rights to Neurelis