Sandoz has recently announced the approval of the AirFluSal Forspiro salmeterol/fluticasone DPI by Norway and Bulgaria, bringing the total number of European approvals to 7. The inhaler has also been approved in Denmark, Germany, Sweden, Hungary, and Romania. The Norwegian approval is for the 50/250 µg and 50/500 µg dosages for the treatment of asthma and for … [Read more...] about AirFluSal Forspiro approved in additional countries
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Arikace to get orphan drug designation from EU
Insmed has announced that the EMA's Committee for Orphan Medicinal Products has issued a positive opinion regarding orphan designation for Insmed's Arikace inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The company says that it plans to report top line results from a Phase 2 trial of Arikace for NTM lung disease by the … [Read more...] about Arikace to get orphan drug designation from EU
Mast Therapeutics to acquire Aires Pharmaceuticals
Mast Therapeutics has announced that it will acquire Aires Pharmaceuticals, which is developing a sodium nitrite inhalation solution for the treatment of pulmonary arterial hypertension. The inhalation solution, known as AIR001 or "Aironite," has received orphan drug status from both the FDA and the EMA. Mast CEO Brian M. Culley commented, "The acquisition of … [Read more...] about Mast Therapeutics to acquire Aires Pharmaceuticals
Flutiform launched in France
Skyepharma has announced the launch of Flutiform fluticasone/formoterol MDI for the treatment of asthma in France. Mundipharma will market the inhaler in 50/5 µg and 125/5 µg versions. The launch triggers a €3.0 million milestone payment from Mundipharma to Skyepharma. Flutiform was approved by the European Commission in 2012 and has now been launched in 14 … [Read more...] about Flutiform launched in France
Rexam selling healthcare business, including OINDP manufacturing
Rexam has announced the decision to sell all three divisions of its Healthcare business: Pharmaceutical Devices, Prescription Retail Packaging and Closures & Containers. Montagu Private Equity has made an offer of $805 million for the Pharmaceutical Devices and Prescription Retail Packaging divisions, and Rexam says it is in talks to sell the Closures & Containers … [Read more...] about Rexam selling healthcare business, including OINDP manufacturing
Chattem launches Nasacort Allergy 24HR nasal spray in US
Sanofi US consumer healthcare division Chattem has announced that Nasacort Allergy 24HR Nasal Spray is now available over the counter in the United States. The FDA approved the triamcinolone acetonide nasal spray as an OTC treatment for allergies in October 2013. Chattem CEO Zan Guerry commented, “Now that Nasacort Allergy 24HR is available over-the-counter, the … [Read more...] about Chattem launches Nasacort Allergy 24HR nasal spray in US
Mark Iwicki named President and CEO of Civitas
Civitas Therapeutics has announced that former Sunovion CEO Mark Iwicki will succeed Glenn Batchelder as President and Chief Executive Officer. Iwicki was most recently CEO of Blend Therapeutics. According to Civitas, which is developing inhaled drugs based on its proprietary ARCUS particle manufacturing and delivery platform, Batchelder will continue to serve on the … [Read more...] about Mark Iwicki named President and CEO of Civitas
Avanir submits NDA for dry powder intranasal sumatriptan
According to Avanir Pharmaceuticals, the company has submitted a 505(b)(2) New Drug Application (NDA) for its AVP-825 intranasal dry powder sumatriptan for the treatment of migraine to the FDA. Avanir acquired the North American license for the product from OptiNose in July 2013. The product uses OptiNose's delivery device, which uses the patient's breath to … [Read more...] about Avanir submits NDA for dry powder intranasal sumatriptan
Romania approves AirFluSal Forspiro
Romania has approved the 50 µg/500 µg dose version of Sandoz's AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD, triggering a €1.5 million milestone payment to Vectura. The inhaler has also been approved recently by Denmark, Germany, Sweden, and Hungary. Read the Sandoz press release. … [Read more...] about Romania approves AirFluSal Forspiro
Copley Scientific launches new MDI testing products
Copley Scientific has announced the launch of its BAC 2000 breath actuated controller and BRS 1100 breathing simulator for the testing of MDIs with spacers and valved holding chambers in accordance with draft US Pharmacopoeia (USP) monograph . Together, the breath actuated controller and breathing simulator provide testing conditions representative of a range of … [Read more...] about Copley Scientific launches new MDI testing products