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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

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

Intranasal aerosol proposed as treatment for snakebite

A group of researchers has published an article in Clinical Case Reports describing successful reversal of induced paralysis in a human volunteer after administration of intranasal aerosolized neostigmine, an anticholinesterase. According to the article, IV administration of anticholinesterases is the first-line treatment for neurotoxic snakebite when antivenom is … [Read more...] about Intranasal aerosol proposed as treatment for snakebite

Patient advocacy group asks FDA to maintain prescription status for corticosteroid nasal sprays

Patient advocacy organization Allergy & Asthma Network Mothers of Asthmatics (AANMA) has released data from a survey of patients using intranasal corticosteroid sprays showing that 90% of the patients surveyed "said they prefer to rely on medical professionals to diagnose and manage their conditions." According to the organization, the survey also showed that more … [Read more...] about Patient advocacy group asks FDA to maintain prescription status for corticosteroid nasal sprays