Insmed has announced that the FDA's Division of Antimicrobial Products has set an advisory committee meeting for August 7, 2018 for review of the company's NDA for ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). Insmed submitted the NDA in March 2018 and … [Read more...] about Date set for FDA advisory committee to review Insmed’s NDA for Alis
News
Recipharm acquires Sanofi’s UK inhalation contract manufacturing business
Recipharm will pay £45 million to Sanofi to acquire Sanofi's UK inhalation contract manufacturing facility and business "in a bid to expand its inhalation capabilities." The 125,000 sq m facility in Holmes Chapel has more than 450 employees and manufactures primarily metered dose inhalers and nasal sprays. The site also has DPI development capabilities. Recipharm … [Read more...] about Recipharm acquires Sanofi’s UK inhalation contract manufacturing business
Mylan says it expects CRL for its generic version of Advair Diskus
Mylan has announced that it was informed by the FDA on June 13, 2018 that the agency will issue a complete response letter regarding Mylan's ANDA for its generic Advair Diskus fluticasone/salmeterol DPI on June 27, 2018. According to Mylan, the reason for the CRL is that the FDA "has identified minor deficiencies." Mylan received a previous CRL for its generic … [Read more...] about Mylan says it expects CRL for its generic version of Advair Diskus
Per Bäckman joins Emmace Consulting
Former Mylan Senior Director of Inhalation Biopharmaceutics Per Bäckman has joined Emmace Consulting as Senior Inhalation Consultant, the company has announced. Bäckman also previously held various positions at AstraZeneca, including as Principal Scientist in Inhalation Biopharmaceutics, and at Novo Nordisk. Emmace Consulting CEO Mårten Svensson said, "Per Bäckman … [Read more...] about Per Bäckman joins Emmace Consulting
Pulmatrix publishes data from Phase 1 study of its PUR0200 tiotropium DPI
Data from a Phase 1 study of Pulmatrix's PUR0200 lactose-free dry powder formulation of tiotropium has been published online in the British Journal of Clinical Pharmacology. The dose-ranging study in patients with moderate-to-severe COPD compared 3 doses of PUR0200 (3 μg, 6 μg, or 9 μg) to Spriva Handihaler (18 μg) and placebo. All doses of PUR0200 produced a … [Read more...] about Pulmatrix publishes data from Phase 1 study of its PUR0200 tiotropium DPI
Lupin launches generic tobramycin inhalation solution in US
Lupin has launched its generic version of Tobi inhalation solution in the US, the company said. The FDA granted final approval of Lupin's ANDA for its tobramycin inhalation inhalation solution in March 2017. The 300 mg/5 ml inhalation solution is indicated for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. Read the Lupin press … [Read more...] about Lupin launches generic tobramycin inhalation solution in US
Phase 1 study MannKind’s Treprostinil Technosphere for PAH achieves primary endpoint
MannKind Corporation has announced that a previously announced Phase 1 study of its Treprostinil Technosphere (TreT) DPI in healthy volunteers has met its primary endpoint of safety and tolerability, and the company is now preparing for a study in patients with pulmonary arterial hypertension (PAH). According to the company, data from the study, which … [Read more...] about Phase 1 study MannKind’s Treprostinil Technosphere for PAH achieves primary endpoint
Spyryx announces encouraging data from ongoing Phase 2 study of SPX-101 for CF
Spyryx Biosciences has announced that data from the first cohort of the Phase 2 HOPE-1 (Hydration for Optimal Pulmonary Effectiveness) study, which was initiated in October 2017, demonstrate improvement in lung function for cystic fibrosis patients independent of type of CF mutation after treatment with SPX-101, an inhaled SPLUNC1-derived peptide. The 46 patients … [Read more...] about Spyryx announces encouraging data from ongoing Phase 2 study of SPX-101 for CF
Evoke submits NDA for Gimoti metoclopramide nasal spray for diabetic gastroparesis
Evoke Pharma has submitted a 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, the company said. Earlier this year, Evoke announced that it had amended its deal with Mallinckrodt to defer milestone payments due on acceptance of review of the Gimoti NDA on final approval, with a single … [Read more...] about Evoke submits NDA for Gimoti metoclopramide nasal spray for diabetic gastroparesis
Pivot Pharmaceuticals signs option agreement for Trivair device for delivery of dry powder cannabinoid formulations
Pivot Pharmaceuticals has announced that the company signed an option agreement with IP Med Inc. for an exclusive worldwide license for use of TriVair nasal and pulmonary breath-propelled devices for delivery of dry powder cannabinoid formulations. Pivot will have 6 months to evaluate the use of the device for delivery of its Ready-To-Infuse-Cannabis ("RTIC") to … [Read more...] about Pivot Pharmaceuticals signs option agreement for Trivair device for delivery of dry powder cannabinoid formulations