Fresenius Kabi USA has announced the availability of 10 ml vials of 20% acetylcysteine inhalation solution. Acetylcysteine inhalation solution has been on the FDA’s drug shortage lists since 2011, in part due to a shutdown of a Luitpold facility. Fresenius Kabi launched 30 ml vials of the product in 2012. According to the current FDA drug shortage list, 10 ml vials … [Read more...] about Fresenius Kabi announces availability of acetylcysteine inhalation solution
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Asmacure reports on Phase 2 trials of ASM-024 inhalation powder
Asmacure has started enrolling patients for a Phase 2 trial of its ASM-024 inhalation powder in patients with moderate and severe COPD, the company has announced. The company said that it has also completed dosing in a Phase 2 study of ASM-024 for the treatment of asthma and expects to report data early in 2014. ASM-024 has both nicotinic and muscarinic effects. … [Read more...] about Asmacure reports on Phase 2 trials of ASM-024 inhalation powder
Retrophin to develop intranasal oxytocin for schizophrenia, autism
Retrophin has taken several steps toward development of intranasal oxytocin for the treatment of schizophrenia and autism, the company has announced. The biopharmaceutical company says that it will acquire Kyalin Biosciences and its lead product, intranasal carbetocin, a synthetic analog of oxytocin, and it has acquired a US license for Novartis's Syntocinon … [Read more...] about Retrophin to develop intranasal oxytocin for schizophrenia, autism
GSK announces new manufacturing facility for Relvar Ellipta DPI
GlaxoSmithKline has announced that it will invest approximately £200 million in UK manufacturing sites, including a new manufacturing facility in Ware for the Relvar Ellipta dry powder inhaler. The DPI was approved in Europe in November 2013 and in the US (as Breo Ellipta) in May 2013. The Ware site already employs more approximately 800 people, with 500 of those … [Read more...] about GSK announces new manufacturing facility for Relvar Ellipta DPI
Evoke Pharma adds executives as gastroparesis nasal spray moves into Phase 3
Evoke Pharma has appointed Marilyn Carlson as Chief Medical Officer and Wayne Alves as Senior Director of Clinical Operations. The company is planning to begin a Phase 3 clinical trial of EVK-001 intranasal metoclopramide for gastroparesis, which is expected to commence in the first half of 2014. Evoke President and CEO Dave Gonyer said, "Dr. Carlson and Dr. Alves … [Read more...] about Evoke Pharma adds executives as gastroparesis nasal spray moves into Phase 3
Tyvaso subject of investigation by US Department of Health and Human Services
According to United Therapeutics, the Office of the Inspector General of the US Department of Health and Human Services has subpoenaed documents related to the marketing of Tyvaso trepostinil inhalation solution for the treatment of pulmonary arterial hypertension. The subpoena covers documents related to two other drugs as well. United Therapeutics says that it plans … [Read more...] about Tyvaso subject of investigation by US Department of Health and Human Services
AeroVanc gets Fast Track and QIDP designations from FDA
Savara Pharmaceuticals has announced that its AeroVanc inhaled vancomycin has received Fast Track designation from the FDA and been designated as a Qualified Infectious Disease Product (QIDP) for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis patients. According to the company, the new designations will result in … [Read more...] about AeroVanc gets Fast Track and QIDP designations from FDA
Study shows diazepam nasal spray administered during seizure comparable to dosing after seizure
Acorda Therapeutics has presented data from a PK study of its diazepam nasal spray showing that dosing during seizure produces comparable pharmacokinetics to dosing immediately following a seizure. The company recently submitted an NDA for intranasal diazepam for the treatment of epilepsy and has said that it expects to market the product as early as 2014 if it is … [Read more...] about Study shows diazepam nasal spray administered during seizure comparable to dosing after seizure
Fluenz Tetra approved in Europe for the prevention of flu in children
The European Commission (EC) has approved MedImmune's Fluenz Tetra intranasal four-strain live attenuated influenza vaccine for the prevention of flu in children aged 24 months to 18 years, parent company AstraZeneca has announced. Fluenz Tetra includes two strains of influenza A and two strains of influenza B; previous vaccines have contained only one strain of … [Read more...] about Fluenz Tetra approved in Europe for the prevention of flu in children
Study shows nasal spray reduces duration of common cold symptoms
Marinomed Biotechnologie has announced that a randomized, double-blind placebo-controlled study of more than 200 patients suffering from the common cold found that patients who received a Carragelose-based nasal spray reduced the duration of symptoms by 2.1 days. Data also showed that patients' viral load was significantly reduced. The study was published in … [Read more...] about Study shows nasal spray reduces duration of common cold symptoms