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
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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
Benjamin Wolin joins the board of Dance Biopharm
Inhaled insulin developer Dance Biopharm has announced that Diplomat Specialty Pharmacy Chairman Benjamin Wolin has joined its board of directors. In 2002, Wolin co-founded digital marketing company Everyday Health and led the company until its acquisition by Ziff Davis in 2016. In December 2017, Dance announced that it had partnered with Phillips-Medisize for … [Read more...] about Benjamin Wolin joins the board of Dance Biopharm
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
Label update for Relvar Ellipta approved by EC
A Type II variation application for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI in patients whose asthma is adequately controlled by an ICS/LABA combination has been approved by the EC, according to GSK and Innoviva. The application was submitted in July 2017, and the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a … [Read more...] about Label update for Relvar Ellipta approved by EC
Hovione announces results of site inspections
CDMO Hovione has announced results from a total of 8 inspections at its manufacturing sites in 2017 as part of a new transparency effort. The report covers pre-approval, GMP, and surveillance inspections by regulators from the US, Russia, Japan, and the EU at sites in Portugal, Macau, and Ireland. Hovione recently announced the addition of commercial DPI capsule … [Read more...] about Hovione announces results of site inspections
Micro-Sphere announces successful GMP inspection of expanded facility
Swiss CDMO Micro-Sphere has announced the completion of a successful GMP inspection by Swissmedic of its facility in Lugano, Switzerland, which recently added to its spray drying and manufacturing capacity. Micro-Sphere offers a range of services for development and manufacturing of DPIs. In September 2017, the company announced that it had added a Harro Höfliger … [Read more...] about Micro-Sphere announces successful GMP inspection of expanded facility
MannKind initiates Phase 1 trial of Treprostinil Technosphere DPI for PAH
MannKind Corporation has announced the initiation of a Phase 1 clinical study of its dry powder formulation of treprostinil based on its Technosphere inhaled delivery technology for the treatment of pulmonary arterial hypertension (PAH). The company said that the Treprostinil Technosphere (TreT) study is being conducted under an IND filed with the FDA in January. … [Read more...] about MannKind initiates Phase 1 trial of Treprostinil Technosphere DPI for PAH
Copley Scientific joins IPAC-RS as an associate member
Inhaler testing equipment company Copley Scientific has joined the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) as an associate member, the company said. According to IPAC-RS, "A corporation is eligible for participation in IPAC-RS initiatives as an associate member if it develops or manufactures components and/or devices for … [Read more...] about Copley Scientific joins IPAC-RS as an associate member