The European Commission has approved Janssen Pharmaceutical's Spravato esketamine nasal spray for the treatment of treatment-resistant major depressive disorder, the company said. The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the MAA for Spravato in October 2019. The FDA approved Spravato for the same … [Read more...] about Spravato approved in Europe
News
Positive topline results for Phase 2/3 trial of Biohaven’s intranasal vazegepant for migraine
Biohaven Pharmaceutical has announced that a Phase 2/3 trial of its intranasal vazegepant (BHV-3500) demonstrated that 10 and 20 mg doses of the intranasal migraine therapy were more effective than placebo for pain relief and that the drug was well tolerated with no indication of liver toxicity. Biohaven announced the initiation of the study in April 2019. The … [Read more...] about Positive topline results for Phase 2/3 trial of Biohaven’s intranasal vazegepant for migraine
3M Drug Delivery Systems sold to Altaris Capital Partners
3M has announced the sale of "substantially all" of 3M Drug Delivery Systems to Altaris Capital Partners for approximately $650 million. 3M will keep a 17% interest in the new business, which is expected to employ approximately 900 of the current employees after the sale is completed. 3M's inhalation products include standard MDIs, a nasal MDI, and the Intelligent … [Read more...] about 3M Drug Delivery Systems sold to Altaris Capital Partners
Oxford Lasers opens contract aerosol imaging facility
Spray characterization specialists Oxford Lasers have opened a new contract services facility to provide drug delivery device testing at their site in Didcot, UK, the company said. Oxford Lasers Imaging Division Manager Seamus Murphy said, “This marks a new milestone for the Oxford Lasers Imaging division. We have been providing services and systems into the … [Read more...] about Oxford Lasers opens contract aerosol imaging facility
Windtree Therapeutics announces completion of $26.4 million private placement
Aerosurf inhaled surfactant developer Windtree Therapeutics has announced the completion of a $26.4 million private placement of common stock and warrants. Net proceeds were approximately $23 million. Windtree is developing several inhaled drugs delivered via the company's proprietary Aerosol Delivery System (ADS). In addition to Aerosurf inhaled KL4 surfactant, … [Read more...] about Windtree Therapeutics announces completion of $26.4 million private placement
VistaGen’s PH94B nasal spray for social anxiety disorder gets Fast Track designation
VistaGen Therapeutics has announced that its PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD) has received Fast Track designation from the FDA. The company says that it is preparing to conduct Phase 3 trials of the nasal spray. In September 2018, VistaGen announced that it had acquired exclusive global rights to PH94B from Pherin … [Read more...] about VistaGen’s PH94B nasal spray for social anxiety disorder gets Fast Track designation
Copley Scientific announces hires of sales and design engineers
OINDP testing experts Copley Scientific have announced the hires of Edward Brundrett, who joins the company as a technical sales executive, and Mark Lo, a mechanical engineer who is joining the company's design team. The company, which significantly expanded its Nottingham, UK headquarters in 2018, noted that its recent acquisition of Novi Systems "brings a new … [Read more...] about Copley Scientific announces hires of sales and design engineers
Chiesi announces plans for lower carbon footprint HFA 152a inhaler by the end of 2025
Chiesi announced that the company has signed an agreement with Koura (formerly Mexichem) for supply of HFA 152a propellant as part of a €350 million plan to bring a pMDI with a 90% lower carbon footprint to market by the end of 2025. The company, which has also pledged that it would be carbon neutral by 2035, made the announcement at the Nations Climate Change … [Read more...] about Chiesi announces plans for lower carbon footprint HFA 152a inhaler by the end of 2025
Phase 2 trial of Theravance’s TD-8236 inhaled JAK inhibitor gets underway
Theravance Biopharma announced that the first patient has been dosed in a Phase 2 study of its TD-8236 inhaled dry powder pan-JAK inhibitor which the company is developing for the treatment of inflammatory lung diseases. In September 2019, the company announced positive results from a Phase 1 SAD/MAD study of TD-8236. The Phase 2 allergen challenge study will … [Read more...] about Phase 2 trial of Theravance’s TD-8236 inhaled JAK inhibitor gets underway
Ultibro Breezhaler added to National Reimbursement Drug List in China
Sosei Group has announced that the Ultibro Breezhaler indacaterol/glycopyrronium DPI has been added to the 2019 National Reimbursement Drug List (NRDL) in China for the treatment of COPD. Novartis launched Ultibro Breezhaler and Seebri Breezhaler in China in March 2019. Sosei Heptares President and CEO Shinichi Tamura commented, "We are pleased that COPD patients … [Read more...] about Ultibro Breezhaler added to National Reimbursement Drug List in China