The Respiratory Technology Team of the Woolcock Institute for Medical Research (WIMR) has announced that a $12,000 International Research Collaboration Award from the University of Sydney will fund a collaboration between the team and Carsten Ehrhardt of Trinity College Dublin. Ehrhardt will perform research on drug absorption of inhaled drugs at WIMR during a … [Read more...] about Trinity College and Woolcock Institute get grant for collaboration
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Inhaled SYK inhibitor fails to meet endpoints in Phase 2 study
Rigel Pharmaceuticals' R343 inhaled SYK inhibitor has failed to meet primary or secondary endpoints in a Phase 2 study, the company said. As a result, Rigel will discontinue development of the product for the treatment of asthma. The company announced the launch of a Phase 2 study called SITAR ((SYK Inhibition for Treatment of Asthma with R343) in September … [Read more...] about Inhaled SYK inhibitor fails to meet endpoints in Phase 2 study
Lightlake Therapeutics announces collaboration with the National Institute on Drug Abuse
Lightlake Therapeutics has announced that the US National Institute on Drug Abuse (NIDA) wiill sponsor a Phase 1 pharmacokinetic study of Lightlake's intranasal naloxone. If the results of the study are positive, the company said, NIDA will file an IND for further studies, with the goal of an FDA approval for intranasal naloxone for the reversal of opioid overdose … [Read more...] about Lightlake Therapeutics announces collaboration with the National Institute on Drug Abuse
NDA filing for aclidinium bromide/formoterol DPI delayed
Forest Laboratories and Almirall have announced that a planned 4th quarter 2013 NDA submission for their aclidinium bromide/formoterol dry powder inhaler will be delayed due to the need to address FDA concerns regarding chemistry, manufacturing and control (CMC) specifications. The companies said that they "are working with the FDA regarding the CMC related comments … [Read more...] about NDA filing for aclidinium bromide/formoterol DPI delayed
MannKind announces positive results from Phase 3 study of Afrezza
MannKind Corporation has announced that preliminary results from two Phase 3 clinical studies of Afrezza inhaled insulin met their primary endpoints. In a study in patients with Type 1 diabetes comparing Afrezza to insulin aspart, Afrezza was shown to be non-inferior in A1c level decreases and showed significant reductions in fasting blood glucose and significantly … [Read more...] about MannKind announces positive results from Phase 3 study of Afrezza
Aegis gets third patent for intranasal triptan formulations
Aegis Therapeutics has announced that it has received New Zealand Patent No. 5937828 for fast acting formulations of triptans that can be administered as nasal, buccal, or sublingual sprays. The company's Intravail formulations have been shown to reach therapeutic levels in the blood 20 to 30 times faster than currently marketed triptan tablets and nasal sprays. … [Read more...] about Aegis gets third patent for intranasal triptan formulations
Dance Biopharm reports positive results from inhaled insulin study
According to Dance Biopharm, a 12-patient, randomized, semi-blinded Phase 1/2 pharmacokinetic study of its Adagio inhaled insulin in patients with Type 1 diabetes demonstrated the safety of the product and showed that it did not cause coughing. The Samba 01 study also showed consistent delivery of insulin, comparable to delivery by injection. Adagio is an inhalation … [Read more...] about Dance Biopharm reports positive results from inhaled insulin study
Adamis acquires Taper DPI from 3M
Adamis Pharmaceuticals has announced that it will exclusively license and then acquire 3M's Taper API-only dry powder inhaler. The company said that "Upon completion of development and clinical activities required to obtain required regulatory approval, Adamis will seek to compete for a share of the Advair market with a branded generic version utilizing 3M's Taper DPI … [Read more...] about Adamis acquires Taper DPI from 3M
Sales of calcitonin nasal sprays in Canada to end
Health Canada has announced that it is withdrawing marketing authorization for calcitonin nasal sprays as of October 1, 2013 due to concerns about cancer risks associated with the products. Injectable calcitonin products will continue to be available with additional warnings on the labels. The agency announced in July 2012 that it would conduct a safety review of … [Read more...] about Sales of calcitonin nasal sprays in Canada to end
PADAC sets meeting date for discussion of Anoro Ellipta NDA
The FDA has announced that its Pulmonary-Allergy Drugs Advisory Committee (PADAC) will hold a public meeting on September 10, 2013 to discuss Glaxo's NDA for the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD. GSK submitted the NDA for the product in December 2012. The FDA will post background materials no later than two business days before … [Read more...] about PADAC sets meeting date for discussion of Anoro Ellipta NDA