Pneuma Respiratory has announced a licensing agreement with Nanjing Leads Biolabs subsidiary Leads Biolabs, Inc. for rights to develop Leads monoclonal antibodies and fusion protein molecules for delivery using Pneuma's digital soft mist inhaler. Pneuma said that it plans to develop inhaled immuno-oncology drugs. Pneuma Respiratory CEO and Co-Founder Eric Hunter … [Read more...] about Pneuma Respiratory licenses mAbs from Leads Biolabs for development of inhaled immuno-oncology therapy
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Milestone Pharmaceuticals raises $82.5 million in IPO
Etripamil developer Milestone Pharmaceuticals announced that its recently closed initial public offering raised approximately $82.5 million gross by selling 5,500,000 common shares at $15/share. The company is developing intranasal etripamil for the treatment of paroxysmal supraventricular tachycardia (PSVT). The intranasal calcium channel antagonist, also known … [Read more...] about Milestone Pharmaceuticals raises $82.5 million in IPO
Phase 3 study of Ryaltris nasal spray for treatment of allergic rhinitis in pediatric patients met primary endpoint
Glenmark Pharmaceuticals recently said that a Phase 3 study comparing Ryaltris olopatadine hydrochloride to placebo in seasonal allergic rhinitis patients aged 6 up to 12 years achieved its primary endpoint. The 14-day study, which enrolled 446 patients, demonstrated a statistically significant improvement in average Reflective Total Nasal Symptom Score (rTNSS), with … [Read more...] about Phase 3 study of Ryaltris nasal spray for treatment of allergic rhinitis in pediatric patients met primary endpoint
PADAC votes to recommend approval of Bronchitol
The FDA's Pulmonary‐Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of Chiesi's NDA for Bronchitol DPI for the treatment of cystic fibrosis in adult patients. According to Bronchitol developer Pharmaxis, Chiesi re-submitted the NDA in December 2018. Bronchitol is already approved in Australia, Russia, and in Europe, where it was okayed in … [Read more...] about PADAC votes to recommend approval of Bronchitol
Recipharm launches integrated inhalation services
Recipharm has announced the launch of an integrated OINDP services program called Inhalation Solutions which covers development of MDIs, DPIs, and nasal sprays from early analytical services to scale up and commercial manufacturing. In June 2018, Recipharm acquired an inhalation manufacturing business in Holmes Chapel, UK from Sanofi. The company also has had … [Read more...] about Recipharm launches integrated inhalation services
Verona initiates Phase 2b study of nebulized ensifentrine for COPD
Verona Pharma said that it has initiated a Phase 2b dose-ranging study of RPL554 nebulized ensifentrine for the treatment of COPD, with results expected by the end of 2019. The company, which reported positive results from a Phase 2 study of an ensifetrine DPI in March 2019, said that it also expects to start a Phase 2 trial of an ensifetrine MDI for COPD this quarter … [Read more...] about Verona initiates Phase 2b study of nebulized ensifentrine for COPD
Vectura awarded $89.7 million in Ellipta patent infringement suit
According to Vectura, a jury has found that US sales of several of GlaxoSmithKline's Ellipta DPIs infringed on Vectura’s US patent 8303991 ("Method of making particles for use in a pharmaceutical composition"). The jury awarded Vectura $89.7 million in damages and found that GSK willfully infringed on the patent, allowing Vectura to ask for enhanced … [Read more...] about Vectura awarded $89.7 million in Ellipta patent infringement suit
Phase 3 study of Trelegy Ellipta for the treatment of asthma meets primary endpoint
GlaxoSmithKline and Innoviva have announced that the Phase 3 CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) study comparing the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI to the Relvar/Breo Ellipta FF/VI DPI in patients with uncontrolled asthma met its primary endpoint. The CAPTAIN … [Read more...] about Phase 3 study of Trelegy Ellipta for the treatment of asthma meets primary endpoint
Intertek Melbourn opens new facility for inhaled drug and biologic development
Intertek has acquired a a new 20,000 sq. ft facility in Melbourn, UK, doubling the size of its existing laboratory facilities at that location, the company said. As part of the expansion, Intertek said, the company plans to hire approximately 100 new employees over 4 years. The new facility, which should open by the end of the year, will have additional space for … [Read more...] about Intertek Melbourn opens new facility for inhaled drug and biologic development
3M announces that it is manufacturing authorized generic of Proventil HFA
3M Drug Delivery Systems has announced that it is manufacturing the authorized generic of Proventil HFA that was recently launched by Par Pharmaceutical. Proventil HFA, which is also manufactured by 3M, is marketed by Merck. 3M DDS Global Business Leader Keith O-Connor commented, “3M Drug Delivery Systems is proud to work with Par to offer patients a lower list … [Read more...] about 3M announces that it is manufacturing authorized generic of Proventil HFA