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
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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
Aradigm gets grant for inhaled liposomal ciprofloxacin studies for treatment of NTM
The US National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), has awarded a Small Business Initiative Research (SBIR) grant of approximately $278,000 to Aradigm to study the use of Aradigm’s Pulmaquin and Lipoquin inhaled liposomal ciprofloxacin products for the treatment of pulmonary non-tuberculous mycobacteria … [Read more...] about Aradigm gets grant for inhaled liposomal ciprofloxacin studies for treatment of NTM
FDA advisory committee recommends approval of Nasacort AQ nasal spray OTC
According to Sanofi, the FDA's Nonprescription Drugs Advisory Committee (NDAC) voted 10 to 6, with two members abstaining, to recommend making Nasacort AQ triamcinolone acetonide nasal spray available without a prescription in the US. If the FDA approves the application, Sanofi's consumer healthcare division, Chattem, Inc. will market Nasacort AQ. Sanofi US Chief … [Read more...] about FDA advisory committee recommends approval of Nasacort AQ nasal spray OTC
Alexza promotes two in management positions
Alexza Pharmaceuticals has announced that it has created two new positions, Vice President, Global Strategic Marketing and New Product Planning and Vice President, Business Development and Global Alliance Management and has promoted Kelly Seither and Tatjana Naranda to fill those positions. Seither has worked for Alexza since 2003 and Naranda since 2005. Alexza's … [Read more...] about Alexza promotes two in management positions