The United States Pharmacopeial Convention (USP) has announced three recipients of its 2014–2015 Global Fellowship Awards. One of the recipients of the $30,000 fellowship, Ahmed Shalash of Alexandria University in Alexandria, Egypt, is researching carriers for dry powder inhaler formulations. According to USP, "The research deals with investigation of the role of … [Read more...] about USP awards fellowship for DPI research
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Fresenius Kabi launches acetylcysteine 10% solution
In addition to its 20% acetylcysteine solution products, Fresenius Kabi is now offering 4 ml, 10 ml, and 30 ml vials of acetylcysteine 10% for oral use or inhalation in the US. Acetylcysteine is a mucolytic used to thin mucous in the lungs of patients with conditions such as cystic fibrosis, bronchiectasis, and pneumonia. The drug was on the FDA's drug shortage list … [Read more...] about Fresenius Kabi launches acetylcysteine 10% solution
FDA advisory committee votes for approval of Spiriva Respimat
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 10-3 to approve Boehringer Ingelheim's Spiriva Respimat tiotropium soft mist inhaler for the treatment of COPD. BI's first NDA submission for tiotropium Respimat took place in 2007. Numerous safety questions about tiotropium have been raised over the years, and a briefing document for the PADAC … [Read more...] about FDA advisory committee votes for approval of Spiriva Respimat
Skyepharma acquires Pulmagen inhalation technology
Skyepharma says that it will begin developing a COPD therapy based on Pulmagen's ICS "re-sensitization" technology (SKP-2075) by the end of 2014 after acquiring the IP and global rights to the Theocort platform from Pulmagen. According to Skyepharma, it plans to spend about £14 million to develop SKP-2075 through Phase 2 and then will seek to out-license the product. … [Read more...] about Skyepharma acquires Pulmagen inhalation technology
Formex LLC hires John McCarty as Scientific Advisor
CDMO Formex, LLC has announced that former Azo Pharma VP of Formulation Development John McCarty has joined the company as Scientific Advisor. McCarty will also serve as a member of the company's Science Advisory Board. Formex cites McCarty's "broad expertise in the development of all major dosage forms" and "over 17" patents. Formex Chief Scientific Officer J. … [Read more...] about Formex LLC hires John McCarty as Scientific Advisor
Presspart to sell 3M dose counters
3M Drug Delivery Systems has announced that it has entered into a licensing agreement with Presspart for sales of the 3M Dose by Dose Counter and dose indicator. 3M DDS President and General Manager Cindy Kent said, “We are excited to partner with a company that possesses the expertise, resources and industry knowledge Presspart has to offer. They understand the … [Read more...] about Presspart to sell 3M dose counters
Cambridge Consultants to expand US drug delivery device development capability
Cambridge Consultants has announced plans to more than triple its US staff to 100+ over the next few years, with a focus on hiring for its medical technology business, especially drug delivery device development. The company has just moved its US headquarters to a new 20,000 sq ft facility Boston and is preparing to launch "an aggressive recruitment campaign" for … [Read more...] about Cambridge Consultants to expand US drug delivery device development capability
Insmed stock offering to support Arikayce development and commercialization
Insmed Incorporated is offering 8.9 million shares of common stock at $11.25 per share, with expected net proceeds of $94 million to go toward continued development of Arikayce liposomal amikacin for inhalation. The company recently announced that it plans to file an MAA for Arikayce for the treatment of refractory nontuberculous mycobacteria (NTM) lung infections and … [Read more...] about Insmed stock offering to support Arikayce development and commercialization
Sanofi partners with MannKind to commercialize Afrezza inhaled insulin
Sanofi will pay MannKind $150 million upfront and milestone payments of up to $775 million for an exclusive development and commercialization license for Afrezza insulin inhalation powder, the companies have announced. The companies will split profits and losses, with Sanofi's share being 65% and MannKind getting 35%. Afrezza, which was approved by the FDA in June … [Read more...] about Sanofi partners with MannKind to commercialize Afrezza inhaled insulin
Adasuve launched in Latin America
Alexza Pharmaceuticals partner Grupo Ferrer has launched its Adasuve loxapine inhalation powder in Guatemala, Alexza has announced. The approval in Guatemala is the first that Ferrer has obtained for Adasuve outside of Europe. Ferrer is responsible for regulatory and commercial activities related to Adasuve in the EU, Latin America and CIS countries. Ferrer Chief … [Read more...] about Adasuve launched in Latin America