Acorda Therapeutics says that it has completed its acquisition of Neuronex, including Neuronex's diazepam nasal spray formulation, for $6.8 million. The company also announced that it plans to submit a 505(b)(2) NDA in 2013 for the diazepam nasal spray as a treatment for seizures in epilepsy patients. In early 2012, Acorda paid $2 million to Neuronex as an option … [Read more...] about Acorda plans to submit 505(b)(2) NDA for diazepam nasal spray
Regulatory
GSK and Theravance submit NDA for UMEC/VI inhaler
GlaxoSmithKline and Theravance say that they have submitted an NDA to the US FDA for an umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD to be marketed under the name "Anoro Ellipta." The LAMA/LABA combination is a once-daily treatment. According to the companies, they plan regulatory filings for UMEC/VI in the European … [Read more...] about GSK and Theravance submit NDA for UMEC/VI inhaler
CHMP issues positive opinion on Adasuve inhaled loxapine
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding Alexza Pharmaceutical's marketing application for Adasuve Staccato loxapine for the treatment of agitation in patients with schizophrenia or bipolar disorder. Alexza filed the MAA in October 2011. According to Alexza, CHMP … [Read more...] about CHMP issues positive opinion on Adasuve inhaled loxapine
“Asthma Inhalers Relief Act of 2012” fails in US House of Representatives
An effort to return remaining units of Primatene Mist epinephrine inhalers to the market failed in the US House of Representatives on December 12, 2012 by a vote of 229-182. Primatene Mist, a CFC-propelled MDI manufactured by Amphastar Pharmaceuticals, was the only over the counter asthma inhaler available in the US until it was removed from the market in accordance … [Read more...] about “Asthma Inhalers Relief Act of 2012” fails in US House of Representatives
FDA issues letter to Alcon over Patanase marketing
The FDA issued a letter to Alcon dated November 13, 2012 regarding a sales aid that the agency says overstates the efficacy of Alcon's Patanase olopatadine hydrochloride nasal spray. In the four-page letter, the agency cites numerous examples of what it says are overstatements of the product's onset of action and the duration of relief and then requests that Alcon … [Read more...] about FDA issues letter to Alcon over Patanase marketing
Next Breath announces successful FDA inspection
Maryland-based CRO Next Breath, which specializes in OINDP analysis, has announced that an October 15, 2012 GMP inspection by the FDA found the company's Baltimore facility to be compliant. The inspection resulted in no Form 483 and no observations. Earlier this year, the World Health Organization (WHO) accredited Next Breath as a testing facility for nasal spray … [Read more...] about Next Breath announces successful FDA inspection
Savara’s AeroVanc gets orphan drug designation in US
According to Savara Pharmaceuticals, the company's AeroVanc inhaled vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients has been granted orphan drug status by the FDA. Aerovanc inhalation powder, which is delivered using a capsule-based DPI, has completed Phase 1 trials, and Savara says that it is … [Read more...] about Savara’s AeroVanc gets orphan drug designation in US
Novartis files application for QVA149 in Japan
QVA149 developers Vectura and Sosei have confirmed that Novartis has submitted an application for Japanese approval of the inhaled fixed dose combination of indacaterol maleate and glycopyrronium bromide for the treatment of COPD. Novartis, which licensed the DPI from the two companies, also recently submitted an application for the product in Europe. Japan … [Read more...] about Novartis files application for QVA149 in Japan
NICE approves Bronchitol inhalation powder for CF
Pharmaxis's Bronchitol mannitol dry powder for inhalation has become the first treatment for cystic fibrosis to receive a positive recommendation from he UK National Institute for Health and Clinical Excellence (NICE), according to the company. The recommendation allows for reimbursement by the National Health Service. Pharmaxis CEO Alan Robertson commented, … [Read more...] about NICE approves Bronchitol inhalation powder for CF
Novartis files MAA for QVA149
Novartis has filed a marketing application with the EMA for its QVA149 indacaterol maleate/glycopyrronium bromide DPI for the treatment of COPD. The filing triggered milestone payments of $5 million each to the drug's developers, Vectura and Sosei. Vectura Chief Executive Chris Blackwell, “The IGNITE program is among the largest COPD clinical trial programs … [Read more...] about Novartis files MAA for QVA149