Lightlake Therapeutics has agreed to license its intranasal naloxone for opioid overdose reversal to Adapt Pharma for possible development and sales milestones of more than $55 million, plus royalties, the company said. Lightlake recently announced that it started a new trial of the product with funding from the National Institute on Drug Abuse (NIDA). According to … [Read more...] about Adapt Pharma to develop Lightlake’s intranasal naloxone for opioid overdose reversal
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GSK to change color of Relvar Ellipta
GSK has announced that it will change the color of the Relvar Ellipta fluticasone/vilanterol DPI starting in January 2015. The company said that it will remove the color blue from the inhaler and its packaging and will change the mouthpiece cover and packaging to yellow. Pharmacists had expressed concerns that patients would be confused because the color blue has been … [Read more...] about GSK to change color of Relvar Ellipta
Acorda announces start of Phase 3 study for inhaled L-dopa
Acorda Therapeutics has announced the enrollment of the first patient in a Phase 3 study of CVT-301 inhaled L-dopa for the treatment of OFF episodes in Parkinson’s disease (PD). The study is expected to enroll about 345 patients. CVT-301 was initially developed by Civitas Therapeutics which was acquired by Acorda earlier this year. Acorda Chief Medical Officer … [Read more...] about Acorda announces start of Phase 3 study for inhaled L-dopa
Shire gets $15 million from CFFT for development of aerosolized mRNA therapy
Cystic Fibrosis Foundation Therapeutics (CFFT), a nonprofit associated with the Cystic Fibrosis Foundation, has announced that it will provide Shire with up to $15 million for development of an aerosol messenger RNA therapy designed to produce working CFTR protein in the lungs of CF patients. Gene mutations in CF patients disrupt normal CFTR protein production, … [Read more...] about Shire gets $15 million from CFFT for development of aerosolized mRNA therapy
Pfizer launches Ultibro Breezhaler in the UK
Pfizer has launched Novartis’ Ultibro Breezhaler indacaterol/glycopyrronium DPI for the treatment of COPD in the UK, the company said. Ultibro Breezhaler was approved in Europe in September 2013. In September 2014, Pfizer announced that it had entered into an agreement with Novartis to market both Ultibro Breezhaler and the Seebri Breezhaler glycopyrronium DPI in … [Read more...] about Pfizer launches Ultibro Breezhaler in the UK
Registration for RDD Europe 2015 opens
RDD Online and Aptar Pharma have announced that registration is now open for Respiratory Drug Delivery (RDD) Europe 2015, to be held May 5-8, 2015 in Antibes, France. This will be the 10th anniversary of the RDD Europe meeting; the most recent RDD Europe drew over 450 attendees to Berlin in May 2013. The 2015 meeting will begin with a plenary lecture by Virginia … [Read more...] about Registration for RDD Europe 2015 opens
Lightlake announces new trial of intranasal naloxone for opioid overdose
Lightlake Therapeutics has announced that it has begun a new trial of its intranasal naloxone for the reversal of opioid overdose. According to the company, it plans to file a New Drug Application with the FDA if the results from this study are positive. Earlier this year, Lightlake announced that it had received funding for the study from the National Institute … [Read more...] about Lightlake announces new trial of intranasal naloxone for opioid overdose
FDA approves PulmoFlow’s Kitabis Pak for CF
PulmoFlow has announced that the FDA has approved its NDA for Kitabis Pak, generic tobramycin inhalation solution packaged with a PARI LC PLUS nebulizer, for the treatment P. aeruginosa infections in cystic fibrosis patients. PARI Respiratory Equipment will distribute the product, which will be priced similarly to generic tobramycin alone, the company said. In … [Read more...] about FDA approves PulmoFlow’s Kitabis Pak for CF
Meda and Cipla sue Apotex over Dymista patents
Meda Pharmaceuticals and Cipla have filed suit against Apotex in the Delaware Federal District Court, claiming that Apotex's submission of an ANDA for a generic version of Dymista azelastine HCl/fluticasone propionate nasal spray violates patents related to Dymista that will not expire until 2026. Meda holds the licenses to US patents 8,163,723 and 8,168,620 … [Read more...] about Meda and Cipla sue Apotex over Dymista patents
Otsuka Pharmaceuticals to acquire Avanir
Avanir Pharmaceuticals, which just received a complete response letter from the FDA for its AVP-825 intranasal sumatriptan powder, has announced that it will be acquired by Otsuka Pharmaceutical for approximately $3.5 billion. Avanir will become an independent subsidiary of Otsuka America. Otsuka Pharmaceutical President and Representative Director Taro Iwamoto … [Read more...] about Otsuka Pharmaceuticals to acquire Avanir