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Hovione provides update on expansion of manufacturing sites

Hovione has provided an update on its ongoing expansion of manufacturing sites in Portugal, Ireland and the US, saying that it has already added significant capacity to the Portuguese and US facilities and has plans to add more in Portugal and Ireland over the next 5 years. According to the company, the expansion in facilities has also led to a 39% increase in … [Read more...] about Hovione provides update on expansion of manufacturing sites

Orion gets positive opinion for salmeterol/fluticasone Easyhaler in EU under the decentralized procedure

Orion Corporation has announced that its salmeterol/fluticasone Easyhaler combination DPI has received a positive opinion under the EU's decentralized procedure, with Sweden as the reference member state. Orion had announced in December 2016 that it planned to submit an MAA in early 2017 based on positive results from a PK study. According to Orion, it will now … [Read more...] about Orion gets positive opinion for salmeterol/fluticasone Easyhaler in EU under the decentralized procedure

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