CF PharmTech, which says it is developing a variety of OINDPs, announced that it has closed a Series E financing round that will be used to support development of its pipeline products. The $90 million round was led by Shanghai-based New Alliance Capital. In August 2017, the company said that it had raised $65 million in a Series D round to support development … [Read more...] about CF PharmTech gets $90 million in latest financing round for inhaled drug development
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FDA grants Breakthrough Therapy designation for Molgradex for aPAP
According to Savara, the FDA has granted Breakthrough Therapy designation for Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). In June 2019, Savara announced that the Phase 3 IMPALA study of Molgradex for that indication had failed to meet its … [Read more...] about FDA grants Breakthrough Therapy designation for Molgradex for aPAP
AstraZeneca’s triple combination MDI approved in China for treatment of COPD
AstraZeneca has announced that its PT010 budesonide/glycopyrronium/formoterol fumarate MDI has been approved by the Chinese National Medical Products Administration for the treatment of COPD. PT010 was approved in Japan as Breztri Aerosphere in June 2019. According to AstraZeneca, the approval was based on results from the Phase 3 KRONOS trial, which had a primary … [Read more...] about AstraZeneca’s triple combination MDI approved in China for treatment of COPD
Evoke resubmits NDA for Gimoti nasal spray
According to Evoke Pharma, the company has resubmitted its 505(b)(2) for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. Evoke originally submitted the NDA for Gimoti in in June 2018 and announced that the FDA had issued a complete response letter to that NDA in April 2019. The company said that the resubmitted NDA includes new … [Read more...] about Evoke resubmits NDA for Gimoti nasal spray
Savara announces $26.8 million private placement
Inhaled drug developer Savara announced that it has entered into a definitive agreement for a private placement of common stock, pre-funded warrants, and milestone warrants with an expected $26.8 million in gross proceeds from sales of the common stock and pre-funded warrants and a potential of up to $75 million if all milestone warrants are exercised. The private … [Read more...] about Savara announces $26.8 million private placement
MedPharm appoints Lynn Allen VP of Business Development
CDMO MedPharm has announced the appointment of Lynn Allen as VP of Business Development, responsible for growing the business in North America. Allen has extensive experience in CDMO business development and was most recently Senior Director of Sales and Marketing at Jubilant HollisterStier. She previously held business development positions with Mylan and DPT … [Read more...] about MedPharm appoints Lynn Allen VP of Business Development
Nanoform applies for GMP certification
Finnish nanonization specialists Nanoform have filed for GMP certification with the Finnish Medicines Agency (FIMEA), the company said. In December 2018, Nanoform announced construction of a new GMP manufacturing facility in Helsinki. The company, which recently won the the 2019 Excellence in Pharma: Formulation award at CPhI, plans to offer GMP clinical … [Read more...] about Nanoform applies for GMP certification
Ryaltris nasal spray approved in Australia
Australia's Therapeutic Goods Administration has approved Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of allergic rhinitis and rhinoconjunctivitis, Glenmark Pharmaceuticals said. The marketing application was submitted by Seqirus, which acquired Australian commercialization rights to the nasal spray in July 2018. Glenmark said … [Read more...] about Ryaltris nasal spray approved in Australia
DDL 2019 highlighted sustainability issues in the inhaled drug delivery industry
For the second year in a row, the annual Drug Delivery to the Lungs meeting drew more than 850 OINDP specialists and 110 exhibitors to the Edinburgh International Conference Centre to catch up on the latest in inhalation research and technology. Much of the meeting focused on issues of sustainability, with discussion centered on reducing the carbon footprint of … [Read more...] about DDL 2019 highlighted sustainability issues in the inhaled drug delivery industry
Recipharm adds SprayView system to OINDP testing facility
CDMO Recipharm has announced an investment of $450,000 for installation of a Proveris Scientific SprayView Measurement System at its facility in Research Triangle Park, North Carolina. The company described the SprayView system as "an important tool that can visualize changes in other critical quality attributes (CQAs) of inhaled and nasal products" and said that it … [Read more...] about Recipharm adds SprayView system to OINDP testing facility