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Savara initiates Phase 2 study of Molgradex for NTM lung infections

Savara, which just announced the discontinuation of its Aironite development program after the failure of a Phase 2 trial to meet its endpoint, says that it has initiated a Phase 2a clinical study of Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infection. … [Read more...] about Savara initiates Phase 2 study of Molgradex for NTM lung infections

Windtree and Eleison Pharmaceuticals partner on potential development of inhaled lipid cisplatin

Windtree Therapeutics and Eleison Pharmaceuticals will jointly evaluate the feasibility of delivering Eleison's inhaled lipid cisplatin (ILC) for the treatment of lung cancer via Windtree's proprietary pulmonary aerosol delivery system (ADS), the companies said. A formulation of ILC incorporating Windtree's KL4 surfactant will also be considered. Eleison, which has … [Read more...] about Windtree and Eleison Pharmaceuticals partner on potential development of inhaled lipid cisplatin

Copley Scientific appoints Richard Postlethwaite as Chief Operating Officer

Copley Scientific has announced the appointment of an experienced lean manufacturing consultant, Richard Postlethwaite, as Chief Operating Officer. Postlethwaite was most recently Senior Operations Manager of Walgreens Boots Alliance and previously held a number of positions at Reckitt Benckiser and Boots. The company, which recently completed an expansion of its … [Read more...] about Copley Scientific appoints Richard Postlethwaite as Chief Operating Officer

Avillion says it has deal to co-develop Pearl’s PT027 for the treatment of asthma

UK-based Avillion announced that it has signed a deal with AstraZeneca subsidiary Pearl Therapeutics for development of Pearl's PT027 budesonide/albuterol MDI for the treatment of asthma. Avillion will finance clinical development and the regulatory submission. Avillion CEO Allison Jeynes-Ellis commented, “This new collaboration is another great example of how our … [Read more...] about Avillion says it has deal to co-develop Pearl’s PT027 for the treatment of asthma

Savara discontinues development of Aironite after Phase 2 trial fails to meet primary endpoint

Savara has announced that the Phase 2 INDIE study of Aironite sodium nitrite inhalation solution for the treatment of heart failure with preserved ejection fraction (HFpEF) failed meet its primary endpoint and, as a result, the company is discontinuing development of the product. Mast Therapeutics acquired Aironite when it acquired Aires Pharmaceuticals in 2014; … [Read more...] about Savara discontinues development of Aironite after Phase 2 trial fails to meet primary endpoint

FDA requests additional clinical trial for Hikma’s generic Advair

According to Hikma Pharmaceuticals, the FDA has concluded the dispute resolution process regarding HIkma's ANDA for its generic version of the Advair fluticasone propionate/salmeterol DPI and has requested a new clinical study. The FDA issued a complete response letter to the ANDA in May 2017. The company affirmed that it "remains committed to bringing this … [Read more...] about FDA requests additional clinical trial for Hikma’s generic Advair

Aradigm submits MAA for Linhaliq

Aradigm has submitted a marketing authorization application to the EMA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. In January 2018, the FDA issued a CRL for Aradigm's NDA for Linhaliq. According to Aradigm, the MAA is supported by … [Read more...] about Aradigm submits MAA for Linhaliq