CDMO Aptuit, which provides inhaled drug development and clinical supply manufacturing services, will be acquired by German CRO Evotec for $300 million, the two companies have announced. Aptuit has about 750 employees at 3 sites in Italy, Switzerland, and the UK. In 2016, Aptuit acquired pre-clinical development specialist Kuecept, which also has extensive … [Read more...] about Aptuit to be acquired by Evotec
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Therevance Biopharma appoints Shehnaaz Suliman as Senior VP, Corporate Development and Strategy
Theravance Biopharma has announced the appointment of former Roche Partnering VP Shehnaaz Suliman as Senior VP, Corporate Development and Strategy. Theravance Biopharma Chairman and CEO Rick E. Winningham commented, "We are thrilled to add an individual of Dr. Suliman's impressive accomplishments, leadership and energy to our senior team. Her successes in the … [Read more...] about Therevance Biopharma appoints Shehnaaz Suliman as Senior VP, Corporate Development and Strategy
Aradigm submits NDA for Linhaliq (formerly Pulmaquin) for non-cystic fibrosis bronchiectasis
Aradigm Corporation has filed a new drug application to for Linhaliq inhaled ciprofloxacin (formerly Pulmaquin) for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE), the company said. The company said that the NDA is supported by positive data from the Phase 3 ORBIT-3 and ORBIT-4 studies. In 2014, … [Read more...] about Aradigm submits NDA for Linhaliq (formerly Pulmaquin) for non-cystic fibrosis bronchiectasis
GSK files sNDA for Arnuity Ellipta
GSK has filed a supplementary NDA for approval of a 50mcg once-daily dose of the Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11. The FDA approved 100mcg and 200mcg doses of Arnuity Ellipta for the treatment of asthma in patients aged 12 and over in August 2014. According to GSK, the sNDA includes data from a 12-week … [Read more...] about GSK files sNDA for Arnuity Ellipta
Samumed’s inhaled Wnt pathway inhibitor gets orphan drug designation
Samumed's SM04646 inhaled Wnt pathway inhibitor has been granted orphan drug designation by the FDA, the company has announced. The company recently announced positive Phase 1 results for SM04646, which it is developing for the treatment of ideopathic pulmonary fibrosis. According to Samumed, SM04646 has the potential for use as either as a combination therapy … [Read more...] about Samumed’s inhaled Wnt pathway inhibitor gets orphan drug designation
GSK submits application to allow use of Relvar Ellipta for adequately controlled asthma
GlaxoSmithKline and Innoviva have announced the filing of a submission to the EMA for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI (marketed as Breo Ellipta in the US) by patients whose asthma is adequately controlled with the use of an ICS/LABA combination. Relvar Ellipta was approved in the EU for the treatment of asthma not adequately … [Read more...] about GSK submits application to allow use of Relvar Ellipta for adequately controlled asthma
Anna Sipitanou joins Copley Scientific as Business Development Manager
Inhaler testing instrument company Copley Scientific has announced the appointment of Anna Sipitanou as Business Development Manager. Sipitanou was most recently Business Development Manager at Cellomatics Biosciences, and her prior experience includes development of IVIVC models as a research associate at Nottingham University. Copley Scientific Sales Director … [Read more...] about Anna Sipitanou joins Copley Scientific as Business Development Manager
Positive results from Phase 3 safety study of nebulized revefenacin
Theravance Biopharma and Mylan have announced that a 12-month Phase 3 safety study of nebulized revefenacin (TD-4208) showed that the drug was well tolerated, with low rates of adverse events and serious adverse events that were comparable to a standard of care treatment arm. The 52-week safety study compared 2 doses of revefenacin to tiotropium. Half of the … [Read more...] about Positive results from Phase 3 safety study of nebulized revefenacin
Opiant Pharmaceuticals reports results from Phase 1 study of intranasal naltrexone for alcohol use disorder
Opiant Pharmaceuticals has announced results from a Phase 1 trial of OPNT002 intranasal naltrexone, which it is developing for the treatment of alcohol use disorder (AUD). According to the company, which recently announced that it had licensed Aegis Therapeutics' Intravail absorption enhancers for use with its opioid antagonists, the addition of Intravail to … [Read more...] about Opiant Pharmaceuticals reports results from Phase 1 study of intranasal naltrexone for alcohol use disorder
Dewmar International files provisional patent application for inhaled cannabinoid lung cancer therapy
Dewmar International says that it has filed a provisional patent application titled "Cannabinoid Formulation to Treat Lung Cancer" with the United States Patent and Trademark Office (USPTO). The companies current brands include "Kush Cakes" psychedelic brownies and "Canna Energy" hemp drinks. According to Dewmar, "The invention relates to an inhalation … [Read more...] about Dewmar International files provisional patent application for inhaled cannabinoid lung cancer therapy