Samumed has announced positive results from a Phase I trial of an inhalation solution of its novel Wnt signaling modulator SM04646, which the company is developing for the treatment of idiopathic pulmonary fibrosis (IPF). The study enrolled 17 healthy subjects and delivered 4 ascending doses of SM04646 in a single inhalation via nebulizer. All doses were well … [Read more...] about Positive Phase 1 results for Samumed’s inhaled Wnt signaling modulator
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Perrigo settles litigation related to Dymista nasal spray
Perrigo announced that it has settled Hatch-Waxman litigation brought by Meda Pharmaceuticals and Cipla regarding Dymista azelastine HCl/fluticasone propionate nasal spray. Meda's NDA for Dymista was approved by the FDA for the treatment of allergic rhinitis in 2012. Meda was acquired by Mylan in 2016. Perrigo Executive VP and President, Rx Pharmaceuticals, … [Read more...] about Perrigo settles litigation related to Dymista nasal spray
MHRA reclassifies Nasonex nasal spray for other the counter sales in UK
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the reclassification of Nasonex mometasone furoate nasal spray from a "POM," or "prescription only medicine," to a "P" medicine, available over the counter at pharmacies with pharmacist supervision. The product is approved for the treatment of allergic rhinitis. Bayer, which acquired … [Read more...] about MHRA reclassifies Nasonex nasal spray for other the counter sales in UK
Sunovion divests US rights to its ciclesonide aerosol products to Covis Pharma
Sunovion has announced that it has agreed to divest US rights to the Alvesco ciclesonide MDI for the treatment of asthma and the Omnaris and Zetonna ciclesonide nasal sprays for the treatment of allergic rhinitis to Covis Pharma. The company acquired the US rights to the products from Takeda in 2008 and launched Alvesco and Omnaris that same year. Zetonna, an HFA … [Read more...] about Sunovion divests US rights to its ciclesonide aerosol products to Covis Pharma
MannKind Corporation hires Patrick McCauley as Chief Commercial Officer
MannKind Corporation has announced the appointment of Patrick McCauley as Chief Commercial Officer, effective immediately. McCauley was most recently Area VP, West US, Urulogy/PCP Sales for Astellas Pharma and had served in various sales and compliance positions with Astellas for the past dozen years. He had previously worked for Yamanouchi Pharma America, … [Read more...] about MannKind Corporation hires Patrick McCauley as Chief Commercial Officer
AstraZeneca to invest A$100 million to expand Pulmicort Respules plant in Australia
During a July 11, 2017 meeting between AstraZeneca CEO Pascal Soriot and Australian Prime Minister Malcolm Turnbull, Soriot announced an A$100 million expansion of the company's manufacturing facility in Sydney, which he called "really a center of excellence for us, for the manufacture of inhaler products for the treatment of asthma and COPD." The Sydney facility … [Read more...] about AstraZeneca to invest A$100 million to expand Pulmicort Respules plant in Australia
Fluidda requests Critical Path Innovation Meeting with FDA as part of biomarker approval initiative
Functional respiratory imaging (FRI) specialist Fluidda has requested a Critical Path Innovation Meeting (CPIM) with the FDA as part of an initiative for approval of its FRI technology as a biomarker, the company said. According to Fluidda CEO Jan de Backer, the company will use the CPIM to bring the FDA up to date on development and validation of FRI, which the … [Read more...] about Fluidda requests Critical Path Innovation Meeting with FDA as part of biomarker approval initiative
Positive interim results from Phase 2 study of Aironite for pulmonary hypertension
Savara Pharmaceuticals has presented interim results from a Phase 2 study of Aironite sodium nitrite inhalation solution for the treatment of pulmonary hypertension at the 4th Annual Drug Discovery and Development Symposium for Pulmonary Hypertension. Savara acquired Aironite when Mast Therapeutics merged with the company earlier this year. Mast had acquired … [Read more...] about Positive interim results from Phase 2 study of Aironite for pulmonary hypertension
Acquisition of Capsugel by Lonza completed
Lonza's acquisition of CDMO Capsugelfrom KKR for $5.5 billion, which was initially announced in December 2016, is now complete, the company said. In 2011, Pfizer sold Capsugel to KKR for just under $2.4 billion, and in 2013, Capsugel expanded its OINDP development and manufacturing services when it acquired Bend Research. The announcement stated that, "With … [Read more...] about Acquisition of Capsugel by Lonza completed
Sunovion has resubmitted the NDA for SUN-101/eFlow glycopyrrolate inhalation solution
The FDA has accepted for review Sunovion's resubmission of the NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD, the company said. Sunovion received a complete response letter to the previously submitted NDA in May 2017. The PDUFA date for the resubmitted NDA is December 15, 2017. The original NDA was accepted for review in … [Read more...] about Sunovion has resubmitted the NDA for SUN-101/eFlow glycopyrrolate inhalation solution