Horizon Pharma has agreed to sell Raptor Pharmaceuticals, which owns the rights to Quinsair levofloxacin inhalation solution in Europe, the Middle East and Africa, to Chiesi Farmaceutici for $70 million and potential sales-based milestone payments, the company said. Horizon will retain rights to Quinsair and another product, Procysbi, in the US, Canada, and Latin … [Read more...] about Chiesi to acquire Raptor Pharmaceuticals and its rights to Quinsair levofloxacin inhalation solution in EMEA regions
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Merxin launches generic capsule based DPI for tiotropium
Generic device company Merxin has announced the launch of its MRX003 dry powder inhaler, an off-the-shelf capsule based DPI intended for generic tiotropium 505j submissions. According to an announcement by Merxin's sister company Aedestra, the MRX003 DPI has the same design and features as the HandiHaler device, including the same air flow, same NGI profile, and … [Read more...] about Merxin launches generic capsule based DPI for tiotropium
Windtree Therapeutics gets $900,000 from SBIR grant
Windtree Therapeutics has received $900,000 from a Small Business Innovation Research Grant (SBIR) grant for Phase 2b trial of Aerosurf aerosolized KL4 surfactant in premature infants with respiratory distress syndrome (RDS) who are receiving nasal continuous positive airway pressure (nCPAP), the company said. In August 2016, Windtree announced that it had … [Read more...] about Windtree Therapeutics gets $900,000 from SBIR grant
Vectura reports positive Phase 1 results for VR942 inhaled biologic
Vectura has announced that it is presenting positive results from a Phase I clinical study of VR942, an inhaled anti-IL-13 monoclonal fragment antibody, at the American Thoracic Society 2017 International Conference. Vectura is partnered with UCB to develop VR942 as a treatment for severe asthma, and the companies expect to begin a Phase 2 study in the second half of … [Read more...] about Vectura reports positive Phase 1 results for VR942 inhaled biologic
CHMP issues positive opinion on Chiesi’s Trimbow triple therapy inhaler
Chiesi Group has announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company's MAA for Trimbow beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide MDI. Chiesi has applied to market the extrafine formulation triple combination ICS/LABA/LAMA for the treatment of COPD. The Trimbow … [Read more...] about CHMP issues positive opinion on Chiesi’s Trimbow triple therapy inhaler
Acorda says it is preparing NDA and MAA for Inbrija inhaled L-dopa, will present new data from Phase 3 trial
Acorda Therapeutics will present new data from a Phase 3 trial of its CVT-301 inhaled L-dopa, which it is now calling Inbrija, at the International Congress of Parkinson’s Disease and Movement Disorders (MDS). The company has previously said that data from the Phase 3 SPAN-PD trial show that CVT-301 significantly improves motor function in Parkinson's Disease … [Read more...] about Acorda says it is preparing NDA and MAA for Inbrija inhaled L-dopa, will present new data from Phase 3 trial
Meggle launches InhaLac 500 micronized lactose for inhalation
Lactose manufacturer Meggle has announced the launch of InhaLac 500 micronized lactose for dry powder inhalation formulations, saying "Combined with high quality and safety, this material meets the most demanding individual dry powder inhalation formulation requirements." According to the company, 90% of the particles in InhaLac 500 are less than 10 µm in size, and … [Read more...] about Meggle launches InhaLac 500 micronized lactose for inhalation
EMA approves Takeda’s multidose Instanyl nasal spray with Aptar Pharma e-Lockout device
Aptar Pharma has announced that its partner Takeda Pharmaceuticals has received approval from the EMA to market a multidose version of its Instanyl fentanyl nasal spray that includes Aptar's e-Lockout integrated electronic lockout device. According to Aptar, Takeda plans to market the product as Instanyl DoseGuard, though no launch date has been announced at this … [Read more...] about EMA approves Takeda’s multidose Instanyl nasal spray with Aptar Pharma e-Lockout device
Insmed announces management appointments
Arikayce inhaled amikacin deveoper Insmed Incorporated has announced the appointments of Paolo Tombesi as Chief Financial Officer, Paul Streck as Chief Medical Officer, and Eugene Sullivan as Chief Product Strategy Officer. Tombesi was most recently VP and Chief Financial and Administrative Officer of Novartis Pharmaceuticals Corporation, and Streck was most … [Read more...] about Insmed announces management appointments
Positive Phase 2 results for Milestone’s intranasal etripamil
Milestone Pharmaceuticals has announced positive results from the Phase 2 NODE-1 study of intranasal etripamil for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT), a type of cardiac arrhythmia. The double-blind dose ranging study enrolled 104 patients who received 1 of 4 doses of intranasal etripamil or placebo after an induced PSVT … [Read more...] about Positive Phase 2 results for Milestone’s intranasal etripamil