Johnson & Johnson has announced that intransal esketamine being developed by its subsidiary Janssen Research & Development has received Breakthrough Therapy Designation from the FDA. According to J&J, the product is in Phase 3 development as a treatment for major depressive disorder with an imminent risk of suicide, and 6 clinical trials are currently … [Read more...] about Janssen’s intranasal esketamine gets Breakthrough Therapy Designation
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Cannabis Science says it will market cannabinoid MDI as rescue inhaler for asthma
Cannabis Science, which recently announced that it would introduce a THC/CBD product for use in nebulizers by asthma/COPD patients, now says that it plans to market a metered dose inhaler called the CBIS MDI Rescue Inhaler "to prevent or treat an asthma/COPD attack." According to the company, the inhalers will be "100 - 200 dose MDI with cannabinoid level … [Read more...] about Cannabis Science says it will market cannabinoid MDI as rescue inhaler for asthma
Anna Slater joins PrEP Biopharm as Head of CMC
Johnson & Johnson spinout PrEP Biopharm has announced that former GSK Global Head of Analytical Technologies Anna Slater has joined the company as Head of Chemistry, Manufacturing and Controls. At GSK, Slater had been a Senior Director in the global Inhaled Product & Device Technology Leadership Team, responsible for CMC development of inhaled and nasal products and … [Read more...] about Anna Slater joins PrEP Biopharm as Head of CMC
Arch Biopartners selects Catalent Inhalation to manufacture inhaled bactericidal drug
Arch Biopartners has announced that Catalent Inhalation will begin the process of manufacturing its AB569 bactericidal inhalation solution for use in trials of the drug in patients with antibiotic resistant lung infections. The process will start with formulation and stability studies and then move on to manufacture of clinical trial supplies, the company said. … [Read more...] about Arch Biopartners selects Catalent Inhalation to manufacture inhaled bactericidal drug
AstraZeneca announces positive results from two Symbicort studies
AstraZeneca has announced top-line results from the Phase 3 RISE (Revealing the Impact of Symbicort in reducing Exacerbations in COPD) and CHASE 3 (ChildHood Asthma Safety and Efficacy) studies of the Symbicort budesonide/formoterol fumarate MDI showing that Symbicort met the primary endpoints in both studies. The RISE study compared twice daily Symbicort MDI … [Read more...] about AstraZeneca announces positive results from two Symbicort studies
Windtree gets $2.6 million for Phase 2b trial of Aerosurf
Windtree Therapeutics has received $1 million from a Phase 2 Small Business Innovation Research Grant (SBIR) worth up to $2.6 million for a Phase 2b trial of its Aerosurf aerosolized KL4 surfactant in premature infants with respiratory distress syndrome (RDS) who are receiving nasal continuous positive airway pressure (nCPAP). The company previously received a … [Read more...] about Windtree gets $2.6 million for Phase 2b trial of Aerosurf
Dr. Reddy’s, Impax acquire inhalation products as part of the Teva/Allergan divestiture
Dr. Reddy’s Laboratories has acquired tobramycin inhalation solution from Teva Pharmaceutical Industries as part of the divestiture required by the US Federal Trade Commission (FTC) before Teva could acquire Allergan's generics business. Teva received FDA approval for itstobramycin inhalation solution in October 2013. As part of the same process, Allergan has … [Read more...] about Dr. Reddy’s, Impax acquire inhalation products as part of the Teva/Allergan divestiture
Adamis gets additional patents for Taper DPI
Adamis Pharmaceuticals says that it has received additional US and European patents for the Taper dry powder inhaler, which the company acquired from 3M Drug Delivery Systems in 2013. In January 2015, Adamis announced that it had received US and Japanese patents for the Taper DPI. The company says that it had received a notice of allowance from the USPTO for … [Read more...] about Adamis gets additional patents for Taper DPI
FDA approves Flonase Sensimist OTC nasal spray
GSK's Veramyst fluticasone furoate nasal spray will soon be available as an over-the-counter product marketed as Flonase Sensimist, GSK Consumer Healthcare has announced. According to the company, the FDA has approved Flonase Sensimist as an OTC treatment for seasonal and allergic rhinitis symptoms. Veramyst was initially approved in 2007. GSK Consumer Healthcare … [Read more...] about FDA approves Flonase Sensimist OTC nasal spray
Altimmune gets up to $120.2 million for development of NasoShield anthrax vaccine
Altimmune has announced that the US Biomedical Advanced Research and Development Authority (BARDA) has awarded the company a contract worth up to $120.2 million over five years for clinical development of NasoShield intranasal anthrax vaccine. An initial amount of $14.3 million will fund a Phase 1 trial of NasoShield, with an additional $105.9 million available for … [Read more...] about Altimmune gets up to $120.2 million for development of NasoShield anthrax vaccine