After announcing in November 2013 that it was in consultations to close its R&D site in Horsham, UK, Novartis has confirmed that the site will stop all operations by the end of June 2014. The respiratory research group at Horsham survived a cutback in 2011, and in 2012, Novartis reaffirmed that it would keep the group at the site. The company says that the decision … [Read more...] about Novartis confirms closure of Horsham R&D site (updated)
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FDA advisory committees vote against recommending approval of Primatene HFA
According to an FDA spokesperson, the FDA Nonprescription Drugs Advisory Committee (NDAC) and Pulmonary Allergy Drugs Advisory Committee (PADAC) voted not to support approval of Armstrong Pharmaceuticals' NDA for Primatene HFA during a joint meeting on February 25, 2014. Armstrong is seeking to market the epinephrine MDI over the counter for the treatment of … [Read more...] about FDA advisory committees vote against recommending approval of Primatene HFA
ITCM is now Molins Technologies
As of February 26, 2014, filling and packaging systems maker ITCM has changed its name to Molins Technologies, bringing the company's brand into line with parent company Molins PLC. As part of the rebranding effort, the company has updated its web site and email addresses. Molins Technologies services related to OINDP filling and packaging remain the same as those … [Read more...] about ITCM is now Molins Technologies
Alexza hires Robert A. Lippe to head operations
Alexza Pharmaceuticals has announced the hire of Robert A. Lippe as Executive VP, Operations and Chief Operations Officer. Lippe was most recently Head of Global Operations & Operational Excellence at Ironwood Pharmaceuticals. The company is in the process of commercializing its Adasuve Staccato inhaled loxapine, which began its launch in Europe in the summer of … [Read more...] about Alexza hires Robert A. Lippe to head operations
Fresenius Kabi launches 4 ml vials of acetylcysteine inhalation solution
Fresenius Kabi USA has announced the immediate availability of 4 ml vials of 20% acetylcysteine solution for inhalation. The company has offered 10 ml vials since 2012 and 30 ml vials since 2013. Acetylcysteine solution for inhalation, a mucolytic agent, had been in short supply in the US since 2011. Several manufacturers, including Ben Venue and American … [Read more...] about Fresenius Kabi launches 4 ml vials of acetylcysteine inhalation solution
Positive opinion from CHMP for umeclidinium monotherapy
Shortly after announcing that the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding Anoro umeclidinium/vilanterol, GSK has announced that CHMP also issued a positive opinion regarding umeclidinium monotherapy. According to GSK, the product would be marketed as "Incruse" and would deliver a 55 mcg dose of UMEC via the … [Read more...] about Positive opinion from CHMP for umeclidinium monotherapy
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