The FDA has issued a new draft guidance titled "Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment," a revision of a 2007 draft guidance with the same title. Among other changes, the 2016 revision includes an appendix regarding use of the St. George’s Respiratory Questionnaire (SGRQ) in COPD studies. In the Federal Register announcement, the … [Read more...] about FDA issues new draft guidance for developing COPD drugs
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Acorda discontinues development of Plumiaz diazepam nasal spray for seizures
Acorda Therapeutics has announced that clinical trials of Plumiaz diazepam nasal spray have failed to demonstrate bioequivalence to Diastat rectal gel, which means that the company is unable to re-file its 505(b)(2) NDA for the product. The FDA had issued a complete response letter (CRL) for the NDA in 2014. As a result, the company says that it is discontinuing … [Read more...] about Acorda discontinues development of Plumiaz diazepam nasal spray for seizures
Study shows nicotine inhaler helps smokers quit
A study published in the journal Nicotine and Tobacco Research found that 32% of smokers using a nicotine MDI plus a nicotine patch quit for 6 months compared to 18% of smokers using a placebo MDI and a nicotine patch. The study enrolled 502 adults who smoked at least 9 cigarettes per day. According to the authors, "The present trial demonstrates that a simple … [Read more...] about Study shows nicotine inhaler helps smokers quit
Merxin launches clear PET MDI cans for R&D work
Generic inhalation device developer Merxin has announced the launch of its MRX002 clear PET pMDI can, which allows developers to observe and model formulations in laboratory settings. According to the company, the cans are compatible with HFA, ethanol, PEG, and glycerol, and will work with commercially available valves. Merxin, which was launched in December 2015 … [Read more...] about Merxin launches clear PET MDI cans for R&D work
Avanir launches Onzetra Xsail in the US
Avanir Pharmaceuticals has announced the launch of Onzetra Xsail sumatriptan nasal powder in the US. The FDA approved Onzetra Xsail for the treatment of migraine in adult patients in January 2016. In 2013, Avanir acquired an exclusive US license for the sumatriptan powder delivered by a bi-directional intranasal delivery device, formerly known as AVP-825, from its … [Read more...] about Avanir launches Onzetra Xsail in the US
NeOnc Technologies initiates Phase 1/2a clinical trial of intranasal perillyl alcohol for glioblastoma
US biotechnology company NeOnc Technologies has announced the initiation of a Phase 1/2a clinical trial of NEO100 intranasal perillyl alcohol (POH) for the treatment of glioblastoma multiforme (GBM), an aggressive brain cancer. Five-year survival for patients with GBM is only 3-5%. The trial is expected to enroll approximately 40 patients in total, and the first … [Read more...] about NeOnc Technologies initiates Phase 1/2a clinical trial of intranasal perillyl alcohol for glioblastoma
Survey shows pulmonologists prefer hand-held nebulizers to MDIs or DPIs for patients with severe COPD
An online survey of 205 pulmonologists and pulmonology fellows conducted by the American Thoracic Society and Sunovion Pharmaceuticals has found that two thirds of the physicians believe that hand-held nebulizers are superior to both MDIs and DPIs for the treatment of severe COPD, and 70% believe that hand-held nebulizers are superior to either MDIs or DPIs for the … [Read more...] about Survey shows pulmonologists prefer hand-held nebulizers to MDIs or DPIs for patients with severe COPD
HHS will support development of NasoShield intranasal anthrax vaccine
The US Department of Health and Human Services (HHS) has announced that its Biomedical Advanced Research and Development Authority (BARDA) has issued a $10.49 million task order to the Centers for Innovation in Advanced Development and Manufacturing (CIADM) at Texas A&M University for development and manufacturing of the NasoShield single dose intranasal anthrax … [Read more...] about HHS will support development of NasoShield intranasal anthrax vaccine
Aptuit acquires Kuecept
CRO Aptuit has acquired preclinical formulation specialist Kuecept Ltd, the company said. Both companies have extensive experience in respiratory drug delivery. Kuecept Founder and CEO Mark Saunders commented, “Since our inception in 2007, we have focused our efforts on the provision of flexible, cost effective and responsive preclinical R&D services. Through this … [Read more...] about Aptuit acquires Kuecept
Grupo Ferrer to acquire Alexza Pharmaceuticals
Grupo Ferrer will acquire inhaled drug developer Alexza Pharmaceuticals for $0.90 per share in a deal that is expected to be completed by mid-2016, the two companies have announced. In February 2016, Alexza announced that it had signed a non-binding letter of intent regarding Ferrer's acquisition offer. Ferrer, which markets Alexza's Adasuve inhaled loxapine in … [Read more...] about Grupo Ferrer to acquire Alexza Pharmaceuticals