Inhaled drug developer Alexza Pharmaceuticals has signed a non-binding letter of intent and entered into discussions with Grupo Ferrer regarding Ferrer's acquisition offer, the company said. Alexza noted that the letter of intent allows the company to continue to explore other options, and there is no guarantee that it will complete the deal with Ferrer. In … [Read more...] about Alexza Pharmaceuticals signs non-binding letter of intent with Grupo Ferrer
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MannKind founder Alfred Mann has died at age 90
MannKind Corporation has announced the death of founder and Chairman Emeritus Alfred Mann at age 90, one week after he stepped down as Chairman of the Board. Mann served as CEO from November 2003 until January 2015 and as Chairman of the Board of MannKind from 2001 until last week. According to the company, Mann's death will have no effect on business activities or … [Read more...] about MannKind founder Alfred Mann has died at age 90
Curida announces alliance with OINDP consultant René Bommer
Norwegian CDMO Curida, which offers a wide range of analytical, development, and manufacturing services for OINDPs, has announced a new strategic partnership with pharmAccel Consulting Director René Bommer. In July 2015, Curida acquired a nasal spray manufacturing facility in Elverum, Norway from Takeda, and the company cites Bommer's expertise in nasal spray … [Read more...] about Curida announces alliance with OINDP consultant René Bommer
Adapt launches Narcan nasal spray in the US
Adapt Pharma has announced the availability of Narcan naloxone hydrochloride nasal spray for the treatment of opioid overdose in the US. Narcan nasal spray was approved by the FDA in November 2015. In 17 of the 50 US states, no prescription is required. According to Adapt, the nasal spray will be available at a discounted price of $37.50 per dose for government … [Read more...] about Adapt launches Narcan nasal spray in the US
Teva Canada launches tobramycin inhalation solution
Health Canada has approved Teva Canada Limited's application for its tobramycin inhalation solution, a generic version of Novartis's TOBI inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients in Canada. The Teva tobramycin inhalation solution is now available in Canadian pharmacies, the company said. Teva Canada Limited … [Read more...] about Teva Canada launches tobramycin inhalation solution
Aptar Pharma teams with Propeller Health on connected MDI
Propeller Health and Aptar Pharma have teamed up to develop a connected MDI that features an integrated sensor and an electronic dose counter. The companies say that they expect to begin clinical studies with the inhaler by the end of 2016 and that they are looking to license the device. The Propeller inhaler tracking platform has received 510(k) clearance from … [Read more...] about Aptar Pharma teams with Propeller Health on connected MDI
Astech Projects acquired by Schauenburg International Group
Laboratory automation company Astech Projects has been acquired by German holding company the Schauenburg International Group. Astech Projects manufactures the Xelair, Xelize, and Xelox ranges of automated inhaler testing systems and offers systems for nasal spray and blister strip testing as well. According to the announcement, all of the management and … [Read more...] about Astech Projects acquired by Schauenburg International Group
FDA accepting comments on draft guidances for rhinitis drug development
The FDA published notices on February 16, 2016 announcing publication of draft guidances titled “Allergic Rhinitis: Developing Drug Products for Treatment” and "Nonallergic Rhinitis: Developing Drug Products for Treatment. The agency says that comments should be submitted by April 18, 2016 for either draft guidance in order to be considered prior to the start of work … [Read more...] about FDA accepting comments on draft guidances for rhinitis drug development
FDA approval for Lannett’s generic version of Imitrex nasal spray
Lannett Company has received FDA approval for its sumatriptan nasal spray, a generic version of GSK's Imitrex nasal spray. The company cites IMS statistics showing that US sales of sumatriptan nasal spray totaled $62 million in 2015. Lannett CEO Arthur Bedrosian commented, "We believe our sumatriptan nasal spray USP, 5 mg/spray and 20 mg/spray will be a … [Read more...] about FDA approval for Lannett’s generic version of Imitrex nasal spray
GDUFA date for Mylan’s generic Advair set for March 2017
The FDA has accepted Mylan's abbreviated new drug application for its generic fluticasone propionate/salmeterol DPI and has set a GDUFA goal date of March 28, 2017, the company said. Mylan filed the ANDA for the generic version of GSK's Advair Diskus in January 2016. Mylan CEO Heather Bresch commented, "The FDA's acceptance of our ANDA filing is an important … [Read more...] about GDUFA date for Mylan’s generic Advair set for March 2017