Insmed Incorporated has announced a proposed underwritten public offering of $60 million of its common stock to fund continued clinical development, regulatory efforts, and commercialization of Arikace inhaled liposomal amikacin, its lead product. The company says that it will also use the funding "to invest in third-party manufacturers and the supply chain in … [Read more...] about Insmed announces public offering of common stock
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GSK and Theravance withdraw Relvar application in Japan
GlaxoSmithKline and Theravance have withdrawn the application for their fluticasone furoate/vilanterol DPI for the treatment of COPD from the Japanese New Drug Application (JNDA) for the drug, the companies say. Review of the JNDA, which was submitted in September 2012, will continue for the FF/VI combination inhaler for the treatment of asthma. If approved, the … [Read more...] about GSK and Theravance withdraw Relvar application in Japan
Breo Ellipta approved in Canada
GlaxoSmithKline has announced that the Breo Ellipta fluticasone furoate/vilanterol DPI has been approved for the treatment of COPD in Canada. GlaxoSmithKline Inc. President Paul Lirette said, "For over forty years, GlaxoSmithKline has been at the forefront of delivering medicines to patients with respiratory diseases. We are committed to responding to patients' … [Read more...] about Breo Ellipta approved in Canada
Astech Projects offers free consultation to celebrate anniversary
Inhaler testing automation supplier Astech Projects is celebrating its 18th anniversary on July 18, 2013 by offering a free consultation and proposal for a laboratory automation system. The company manufactures semi- to fully-automated dose content uniformity, Andersen cascade impactor (ACI), and Next Generation Impactor (NGI) testing systems, plus a number of other … [Read more...] about Astech Projects offers free consultation to celebrate anniversary
Court issues final judgment in Perforomist case in favor of Mylan
The US District Court for the Southern District of New York has issued a final judgment and order affirming the validity of five patents related to Mylan's Perforomist formoterol fumarate inhalation solution and stating that Sunovion's Brovana inhalation solution infringes the Mylan patents. Mylan had appealed after the five patents were invalidated in March 2012; two … [Read more...] about Court issues final judgment in Perforomist case in favor of Mylan
Melbourn Scientific acquired by Intertek
According to multi-industry laboratory company Intertek, it has acquired OINDP testing specialist Melbourn Scientific. In its announcement, Intertek cites Melbourn's "profound expertise in all aspects of characterization of orally inhaled and intra-nasal products (OINDP)" and "an increasing demand worldwide for more patient friendly drug delivery methods for optimum … [Read more...] about Melbourn Scientific acquired by Intertek
Trimel’s NDA for intranasal testosterone product accepted by the FDA
Trimel Pharmaceuticals has announced the acceptance of its NDA for CompleoTRT bioadhesive intranasal gel testosterone and the PDUFA date, February 28, 2014. The company announced submission of the NDA at the end of April 2013. According to Trimel, CompleoTRT is an intranasal gel with no smell or taste, delivered using a multi-dose applicator, that will eliminate … [Read more...] about Trimel’s NDA for intranasal testosterone product accepted by the FDA
RDD China cancelled
According to RDD Online, the RDD China meeting scheduled to take place October 16-18, 2013 in Beijing has been cancelled due to "contractual problems which made it impossible for RDD to guarantee the quality of the conference and ensure that all exhibitors and workshop presenters would be treated equitably." The meeting, which was to be co-sponsored by the Chinese … [Read more...] about RDD China cancelled
Prosonix appoints Frank Condella as Non-Executive Director
Inhaled pharmaceuticals company Prosonix has announced the appointment of Columbia Laboratories President and CEO Frank Condella as a Non-executive Director of Prosonix. Condella has held numerous position in the pharmaceutical industry, including as CEO of SkyePharma from 2006 to 2008 and President of European Operations and Managing Director, UK at IVAX Corporation … [Read more...] about Prosonix appoints Frank Condella as Non-Executive Director
Avanir makes deal with OptiNose for intranasal sumatriptan powder
Avanir Pharmaceuticals has paid $20 million up front to OptiNose for an exclusive North American license for development and commercialization of OptiNose's intranasal low-dose sumatriptan powder for the treatment of acute migraines. OptiNose could receive an additional $90 million in milestone payments and, if the product is approved, Avanir will make royalty … [Read more...] about Avanir makes deal with OptiNose for intranasal sumatriptan powder