Insmed Incorporated has announced that it will go ahead with two clinical trials of its Arikace liposomal amikacin for inhalation for non-tuberculous mycobacteria (NTM) lung disease and for P. aeruginosa infections in CF patients despite the continuing clinical hold placed by the FDA on the latter application. The FDA lifted the hold on Arikace for NTM earlier … [Read more...] about Insmed moving ahead with Arikace trials despite FDA clinical hold
Regulatory
Almirall files new applications for Sativex in Europe
Almirall has announced the filing of new applications for its Sativex endocannabinoid oromucosal spray for the treatment of spasticity in multiple sclerosis in ten additional countries: Belgium, Finland, Iceland, Ireland, Luxemburg, the Netherlands, Norway, Poland, Portugal and Slovakia. The product is currently available in Denmark, Germany, Spain, UK, Canada, and … [Read more...] about Almirall files new applications for Sativex in Europe
FDA clears Neurelis IND for intranasal diazepam
The FDA has accepted an Investigational New Drug application (IND) submitted by San Diego, CA pharmaceutical company Neurelis. The company is cleared to begin clinical trials for the development of its NRL-1 intranasal diazepam for the treatment of acute breakthrough seizures. According to the company, it filed the IND "based upon the encouraging human pharmacokinetic … [Read more...] about FDA clears Neurelis IND for intranasal diazepam
Optinose files IND for intranasal sumatriptan
According to OptiNose, it filed an investigational new drug (IND) application for an intranasal sumatriptan product with the US FDA in December, 2011, and the FDA has given OptiNose permission to proceed. The company now plans to begin Phase 3 trials in adults with acute migraine. “This filing signals an important milestone in our quest to deliver improved relief … [Read more...] about Optinose files IND for intranasal sumatriptan
Discovery Labs gets authorization for Afectair device in US
Discovery Laboratories has announced that the FDA has approved the Afectair device for marketing in the US, and the company plans a launch later this year. The company describes Afectair as "a proprietary patient interface technology that simplifies delivery of aerosolized medications to patients requiring ventilator support" and estimates that it could bring in … [Read more...] about Discovery Labs gets authorization for Afectair device in US
Meda files patent infringement suit against Apotex, Perrigo
Meda Pharmaceuticals has filed a patent infringement suit against Apotex and Perrigo in US District Court in regard to their generic versions of its Astepro azelastine nasal spray for the treatment of rhinitis. The suit alleges infringement of a patent granted to Meda in December 2011 when the two companies submitted abbreviated new drug applications for generic … [Read more...] about Meda files patent infringement suit against Apotex, Perrigo
FDA review of Adasuve application extended
According to Alexza Pharmaceuticals, the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for the Adasuve Staccato loxapine NDA from February 4, 2012 to May 4, 2012. On January 10, 2012, Alexza submitted an updated proposed Risk Evaluation and Mitigation Strategy (REMS) program, which the FDA is considering a major amendment, allowing the agency to … [Read more...] about FDA review of Adasuve application extended
FDA lifts clinical hold on Arikace for NTM
According to Insmed, the US FDA has lifted the clinical hold on Arikace liposomal amikacin for inhalation for the treatment of patients with non-tuberculous mycobacteria (NTM) lung disease. In October 2011, the FDA had asked for additional data for that indication. The hold on Arikace for the treatment of P. aeruginosa infections in cystic fibrosis patients remains in … [Read more...] about FDA lifts clinical hold on Arikace for NTM
Wockhardt to launch generic fluticasone nasal spray in US
Mumbai-based pharmaceutical and biotechnology company Wockhardt says that it will launch its generic version of GSK's Flonase fluticasone nasal spray in the US immediately after having received approval from the US FDA. The company will manufacture the 50 mcg dose nasal spray for the treatment of allergic rhinitis at its facility in Morton Grove, IL. No other nasal … [Read more...] about Wockhardt to launch generic fluticasone nasal spray in US
GSK says “totality of the data” gives it confidence to submit applications for Relovair
GlaxoSmithKline and Theravance have announced the completion of Phase 3 studies of their Relovair fluticasone furoate/vilanterol DPI for COPD. One Phase 3 study for the treatment of asthma remains to be completed. Despite the fact that the studies failed to produce statistically significant improvements in a number of measures, GSK says that it will submit … [Read more...] about GSK says “totality of the data” gives it confidence to submit applications for Relovair