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St. Renatus completes Phase 3 studies on intranasal dental anesthetic

St. Renatus has announced the completion of adult and pediatric Phase 3 clinical studies of its nasal mist dental anesthesia and says that it is now working on data analysis with the goal of submitting an NDA for the product in 2014. The nasal anesthetic numbs the upper teeth without affecting the patient's lips or face. St. Renatus CEO Steve Merrick commented, "We … [Read more...] about St. Renatus completes Phase 3 studies on intranasal dental anesthetic

Teva gets positive opinion from CHMP for DuoResp Spiromax

According to Teva, the company's DuoResp Spiromax budesonide/formoterol fumarate inhalation powder has received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). The company has applied to market the product in Europe for the treatment of asthma and COPD. Teva President of Global R&D and Chief Scientific Officer Michael … [Read more...] about Teva gets positive opinion from CHMP for DuoResp Spiromax

Invion and 3M to collaborate on inhaled nadolol, zafirlukast

Invion will work with 3M Drug Delivery Systems to develop inhaled formulations of nadolol and zafirlukast to be delivered using 3M's MDI technology. If inhaled delivery of INV102 (nadolol) and INV104 (zafirlukast) for the treatment of asthma, COPD, and CF proves feasible, the two companies plan to develop the products through to commercialization. Invion is … [Read more...] about Invion and 3M to collaborate on inhaled nadolol, zafirlukast

AANMA objects to Primatene HFA

Tonya Winders, President and CEO of Allergy & Asthma Network Mothers of Asthmatics (AANMA) will speak in opposition to the approval of Primatene HFA at the upcoming joint meeting of the FDA's Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Committee, the organization has announced. The AANMA contends that Armstrong's OTC Primatene HFA … [Read more...] about AANMA objects to Primatene HFA

CURx Pharmaceuticals licenses Fosfomycin/Tobramycin for Inhalation from Gilead

Sad Diego-based CURx Pharmaceuticals has announced a global license agreement with Gilead Sciences for development of Fosfomycin/Tobramycin for Inhalation (FTI) to treat Pseudomonas aeruginosa lung infection in cystic fibrosis (CF) patients. Gilead initiated a Phase 2 study of the product, then known as GS 9310/11 in late 2008, and CURx says that FTI is ready for … [Read more...] about CURx Pharmaceuticals licenses Fosfomycin/Tobramycin for Inhalation from Gilead

Insmed provides update on ongoing study of Arikace for P. aeruginosa infections in CF patients

Insmed says that it is pleased with results from its ongoing CLEAR-110 extension study of Arikace inhaled liposomal amikacin for the treatment of P. aeruginosa infections in cystic fibrosis patients. Data from 98 patients who completed the first year of the two-year study showed that Arikace was well tolerated, the company said, and patients experienced continued … [Read more...] about Insmed provides update on ongoing study of Arikace for P. aeruginosa infections in CF patients

Maurice Chagnaud to develop Lupin’s inhalation strategy

Lupin Pharmaceuticals has announced that Maurice Chagnaud has joined the company as President, Europe and Head of Inhalation Strategy. He was most recently Senior Vice President, Central & Eastern Europe at Teva. Chagnaud's responsibilities will include Lupin's European business as well as the company's "core strategy for inhalation in the developed markets." Lupin … [Read more...] about Maurice Chagnaud to develop Lupin’s inhalation strategy