Business

Inhalation particle design and manufacturing specialist Hovione has announced the completion of an FDA GMP and postmarket approval inspection of its manufacturing plant in Loures, Portugal. According to the company, no Form 483 was issued after the 5-day inspection, which was completed on September 27, 2013, and the inspector "informed that she was satisfied with what … [Read more...] about Hovione announces successful FDA inspection

Transcept Pharmaceuticals has acquired global development and commercialization rights to Shin Nippon Biomedical Laboratories' TO-2070 dihydroergotamine (DHE) nasal powder for the treatment of migraine, the companies announced. Transcept will pay $1 million up front plus development milestones totaling $6.5 million, commercialization milestones of up to $35 million, … [Read more...] about Transcept licenses intranasal DHE

The US Patent and Trademark Office (USPTO) has issued notices of allowance for two Mystic Pharmaceuticals patents related to its VersiDoser and VRx2 intranasal delivery platforms. The VersiDoser platform is used for packaging and aerosol delivery of liquid formulations; the VRx2 platform can be used for powder formulations. The patent applications are titled “Unit … [Read more...] about Mystic Pharmaceuticals gets US patents for intranasal delivery platforms

Chiesi Farmaceutici will acquire all outstanding shares of Cornerstone Therapeutics for $9.50 per share, the companies have announced. Chiesi already owns almost 60% of Cornerstone outstanding common shares. Cornerstone announced in February 2013 that it had received an offer of between $6.40 and $6.70 per share from Chiesi. According to Chiesi, "The acquisition … [Read more...] about Chiesi to acquire Cornerstone Therapeutics

Sigma-Tau PharmaSource and Aradigm have announced that Sigma-Tau PharmaSource will provide clinical and commercial manufacturing services for Aradigm's Pulmaquin inhaled ciprofloxacin. Pulmaquin is in Phase 3 development for the treatment of non-cystic fibrosis bronchiectasis. Terms of the agreement were not disclosed. Sigma-Tau Pharmaceuticals CEO Dave Lemus … [Read more...] about Sigma Tau to manufacture Aradigm’s Pulmaquin inhaled ciprofloxacin

Activaero has announced that it will collaborate with Chiesi Farmaceutici on an inhaled treatment for cystic fibrosis that would deliver a Chiesi drug using Activaero's FAVORITE (Flow And Volume Regulated Inhalation Technology) system. Financial details were not disclosed. According to Activaero, the initial portion of the collaboration should be complete by the end … [Read more...] about Activaero and Chiesi to collaborate on inhaled CF drug

Civitas Therapeutics will use $38 million in new financing for continued development of its CVT-301 inhaled L-dopa through Phase 3 clinical trials, the company has announced. A Phase 2B study of the drug, which is delivered using the Arcus DPI, was initiated earlier this month. Civitas is developing the Arcus API-only dry powder formulation of levodopa for the … [Read more...] about $38 million in financing for Civitas’s inhaled L-dopa program