AeroVanc developer Savara Pharmaceuticals has acquired Serendex Pharmaceuticals, which is developing Molgradex inhaled granulocyte-macrophage colony-stimulating factor (molgramostim) for the treatment of autoimmune pulmonary alveolar proteinosis (PAP). Serendex announced in September 2015 that it was initiating a Phase 2 clinical trial of Molgradex, which is delivered … [Read more...] about Savara Pharmaceuticals acquires Serendex, inhaled molgramostim
Business
Ferrer completes merger with Alexza
In May 2016, Grupo Ferrer announced that it would acquire inhaled drug company Alexza Pharmaceuticals; as of June 21, 2016, the company says, Ferrer Pharma has merged into Alexza Pharmaceuticals, with Alexza now a wholly owned subsidiary of Ferrer. Ferrer already marketed Alexza's Staccato inhaled loxapine in much of the world and had become Alexza's largest … [Read more...] about Ferrer completes merger with Alexza
Nephron Pharmaceuticals launches generic budesonide inhalation suspension
US generic inhalation solutions manufacturer Nephron Pharmaceuticals has licensed Apotex's generic budesonide inhalation suspension, a generic version of AstraZeneca's Pulmicort Respules, and subsequently launched the product in the US, the company said. Nephron will manufacture, market, and distribute 0.5mg/2mL and 0.25mg/2mL dosage forms. The company's other … [Read more...] about Nephron Pharmaceuticals launches generic budesonide inhalation suspension
MannKind partners with JDRF on pediatric use of Afrezza
MannKind Corporation has announced that it signed an agreement with JDRF (formerly the Juvenile Diabetes Research Foundation) to collaborate on research focused on the use of Afrezza inhaled insulin in pediatric diabetes patients. JDRF is the largest non-profit funder of type 1 diabetes research in the world, according to the organization. The FDA approved … [Read more...] about MannKind partners with JDRF on pediatric use of Afrezza
Innovus Pharmaceuticals updates on plans for OTC FlutiCare nasal spray
California-based Innovus Pharmaceuticals announced that it has signed a manufacturing agreement for its FlutiCare fluticasone propionate nasal spray in anticipation of FDA approval, which it expects in the 3rd quarter of 2016. No details were revealed. The company acquired rights to the nasal spray in February 2015; an ANDA for the OTC version had been filed by … [Read more...] about Innovus Pharmaceuticals updates on plans for OTC FlutiCare nasal spray
Perrigo and Hikma get FDA approval for and launch generic fluticasone propionate nasal spray
Perrigo and Hikma subsidiary West-Ward Pharmaceuticals have launched an OTC fluticasone propionate nasal spray, a generic version of Flonase, in the US after receiving approval for the product from the FDA, the companies said. The nasal spray will be marketed under store brand names. Flonase was approved for over-the-counter sales in the US in 2014. Hikma … [Read more...] about Perrigo and Hikma get FDA approval for and launch generic fluticasone propionate nasal spray
Vectura partners with Propeller Health to develop connected inhalers
Vectura Group and Propeller Health have announced that they will partner to develop a connected version of Vectura's LOMI (lever-operated multi-dose inhaler) DPI using Propeller's digital technology. The LOMI device, which is based on Vectura's GyroHaler, uses blister strips to deliver up to 60 doses. According to the announcement, discussions are underway to … [Read more...] about Vectura partners with Propeller Health to develop connected inhalers
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
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
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