The FDA has approved Duaklir Pressair aclidinium bromide/formoterol fumarate DPI for the treatment of COPD, Circassia Pharmaceuticals has announced. Circassia said in August 2018 that the FDA had accepted the NDA for Duaklir and an sNDA for Tudorza Pressair aclidinium bromide DPI, which has also been approved. The company says that it plans to launch Duaklir in the … [Read more...] about FDA approves Duaklir Pressair for the treatment of COPD
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Biohaven initiates Phase 2/3 study of BHV-3500 intranasal therapy for migraine
Biohaven Pharmaceutical said that it has initiated a Phase 2/3 study of its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist for the treatment of migraine. The company announced positive results from a Phase 1 study of BHV-3500 in February 2019. The trial will compare 5, 10, and 20 mg doses of BHV-3500 delivered by Aptar Pharma's Unit … [Read more...] about Biohaven initiates Phase 2/3 study of BHV-3500 intranasal therapy for migraine
Tudorza sNDA for label change approved
According to Circassia Pharmaceuticals, the FDA has approved the company's sNDA for the addition of data from the Phase 4 ASCENT study of the Tudorza Pressair aclidinium bromide DPI in COPD patients showing significant reduction in exacerbations and hospitalizations to the inhaler's label. Circassia announced in August 2018 that the FDA had accepted the sNDA for … [Read more...] about Tudorza sNDA for label change approved
McGill University team gets funding for project evaluating intranasal insulin for postoperative cognitive impairment
The Alzheimer’s Drug Discovery Foundation has awarded a grant worth approximately $1.2 million to a team led by Hiroaki Sato and Thomas Schricker at the Research Institute of the McGill University Health Centre (RI-MUHC) for research into the effectiveness of intranasal insulin for delirium and cognitive dysfunction experienced by patients following surgery. Sato … [Read more...] about McGill University team gets funding for project evaluating intranasal insulin for postoperative cognitive impairment
Phase 1b trial of Auris Medical’s intranasal betahistine gets underway
Auris Medical has announced the initiation of a Phase 1b proof-of-concept study of its AM-201 intranasal betahistine, which the company is developing for the prevention of weight gain and sleepiness in patients taking olanzapine. The 4-week dose escalation study is expected to compare 5 different doses of AM-201 to placebo in 50 healthy volunteers who will also … [Read more...] about Phase 1b trial of Auris Medical’s intranasal betahistine gets underway
Mundipharma initiates Phase 3 trial of Penthrox in trauma patients rescued from hostile environments
Mundipharma has announced enrollment of the first patient in the Phase 3b METEORA trial of Penthrox inhaled methoxyflurane in patients with limb trauma who have been rescued by helicopter from hostile terrain and are suffering from moderate-to-severe pain. The study is expected to enroll 200 adult patients rescued by Italian helicopter emergency medical services, … [Read more...] about Mundipharma initiates Phase 3 trial of Penthrox in trauma patients rescued from hostile environments
Synspira Therapeutics appoints Robert Gallotto as President and CEO
Synspira Therapeutics, which is developing an inhaled therapy for cystic fibrosis, has announced the appointment of Robert Gallotto as President and CEO. Gallotto was most recently President and co-founder of Alcresta Therapeutics. He previously co-founded Allena Pharmaceuticals and served in executive positions at Alnara Pharmaceuticals, Altus Pharmaceuticals, and … [Read more...] about Synspira Therapeutics appoints Robert Gallotto as President and CEO
Third Pole Therapeutics to collaborate with Actelion on inhaled nitric oxide development
Third Pole Therapeutics, which is developing an inhaled nitric oxide (iNO) generator, has announced a strategic collaboration agreement with Actelion Pharmaceuticals. Details of the agreement were not specified. Third Pole's iNO platform is designed for more convenient delivery than the compressed gas cylinders currently in use. The Third Pole device is primarily … [Read more...] about Third Pole Therapeutics to collaborate with Actelion on inhaled nitric oxide development
Breath Therapeutics initiates Phase 3 trials of nebulized liposomal cyclosporine A for bronchiolitis obliterans
Breath Therapeutics has announced the initiation of Phase 3 studies of its L‑CsA‑i inhaled liposomal cyclosporine A for the treatment of bronchiolitis obliterans. Breath Therapeutics licensed L-CsA-i from PARI in 2017, and the drug is delivered via PARI's eFlow nebulizer. The 48-week BOSTON-1 and BOSTON-2 studies are each expected to enroll 110 lung transplant … [Read more...] about Breath Therapeutics initiates Phase 3 trials of nebulized liposomal cyclosporine A for bronchiolitis obliterans
FDA advisory committee sets date for meeting to reconsider NDA for Bronchitol DPI
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) will meet on May 8, 2019 to consider Chiesi's NDA for Bronchitol mannitol DPI for the treatment of cystic fibrosis. According to Bronchitol developer Pharmaxis, its partner Chiesi resubmitted the NDA in December 2018. Bronchitol was approved for the treatment of CF in Europe in 2012, but the FDA issued a … [Read more...] about FDA advisory committee sets date for meeting to reconsider NDA for Bronchitol DPI