Savara has announced that it will develop its Molgradex inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infection and plans to initiate a Phase 2a trial for that indication in early 2018. The company is also developing Molgradex for the treatment of autoimmune pulmonary alveolar … [Read more...] about Savara to develop Molgradex for the treatment of NTM lung infections
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Sunovion launches Seebri Neohaler in the US
Sunovion has announced the US launch of Seebri Neohaler glycopyrrolate DPI for the treatment of COPD. Seebri Neohaler was approved by the FDA in October 2015. Sunovion acquired US rights to Seebri Neohaler, along with the Arcapta indacaterol and Utibron indacaterol/glycopyrrolate Neohalers, from Novartis in December 2016. Seebri Neohaler is known as Seebri … [Read more...] about Sunovion launches Seebri Neohaler in the US
Amneal and Impax announce merger agreement
Amneal Pharmaceuticals and Impax Laboratories have announced that the companies will merge, with the new company to be called Amneal Pharmaceuticals, Inc. The merger is expected to be complete by mid-2018. OINDPs marketed by Amneal include generic versions of TOBI inhalation solution and Astelin and Nasonex nasal sprays. Impax acquired US rights to Zolmig … [Read more...] about Amneal and Impax announce merger agreement
Aegis Therapeutics announces availability of intranasal hydromorphone formulation
Aegis Therapeutics says that it has developed an intranasal hydromorphone for the treatment of acute pain and is making the formulation available for license. According to the company, the formulation, which is based on the Intravail absorption enhancement technology, has demonstrated rapid onset and a Tmax of 7.5 minutes. A patent application filed by Aegis in … [Read more...] about Aegis Therapeutics announces availability of intranasal hydromorphone formulation
Engage Therapeutics closes $23 million series A financing round to fund development of inhaled alprazolam
Engage Therapeutics has closed a $23 million Series A financing round led by TPG Biotech that will fund a Phase 2b clinical trial of an inhaled alprazolam for the treatment of acute epileptic seizures. Alexza Pharmaceuticals, which has developed the Staccato alprazolam through Phase 2a, registered the trademark for Engage Therapeutics in 2015. According to one … [Read more...] about Engage Therapeutics closes $23 million series A financing round to fund development of inhaled alprazolam
Galen acquires US rights to Adasuve inhaled loxapine
Galen US has acquired US rights to Alexza Pharmaceuticals' Adasuve inhaled loxapine for the treatment of agitation in patients with schizophrenia or bipolar I. Adasuve was approved by the FDA in December 2012 for use in certain healthcare facilities enrolled in the Adasuve REMS program only. In May 2013, Teva announced that it had acquired US rights to Adasuve, and … [Read more...] about Galen acquires US rights to Adasuve inhaled loxapine
4D Molecular Therapeutics gets $3 million from CFFT for development of aerosol gene therapy
4D Molecular Therapeutics (4DMT) has received $3 million from Cystic Fibrosis Foundation Therapeutics (CFFT) for development of 4D-710, an aerosolized adeno-associated virus (AAV) gene therapy vector that will deliver a functional copy of the CFTR gene to the lungs of CF patients, the company said. The funding will be used for completion of studies to support an … [Read more...] about 4D Molecular Therapeutics gets $3 million from CFFT for development of aerosol gene therapy
Emergent BioSolutions gets BARDA grant worth up to $63 million for development of intranasal cyanide antidote
The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) has awarded a grant worth up to $63 million to Emergent BioSolutions for development of a single-use stabilized isoamyl nitrite (SIAN) nasal spray for the treatment of acute cyanide poisoning. The initial 17-month, $12.7 million agreement will cover … [Read more...] about Emergent BioSolutions gets BARDA grant worth up to $63 million for development of intranasal cyanide antidote
Insmed public offering nets over $377 million
Insmed has closed a public offering of common stock that generated net proceeds of ~$377.7 million, the company said. The proceeds will be used in large part for continued development, regulatory submissions, and potential commercialization of ALIS amicakin liposome inhalation suspension. According to the announcement, planned uses for the proceeds include "invest … [Read more...] about Insmed public offering nets over $377 million
Pulmatrix licenses PUR0200 dry powder tiotropium to Vectura
Pulmatrix has announced a licensing agreement with Vectura for US development of Pulmatrix's PUR0200 dry powder tiotropium formulation for the treatment of COPD. Vectura will pay Pulmatrix a $1 million "technology access fee" on achievement of certain milestones and will take responsibility for US development beginning immediately. According its own announcement, … [Read more...] about Pulmatrix licenses PUR0200 dry powder tiotropium to Vectura