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
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Sigma Tau to manufacture Aradigm’s Pulmaquin inhaled ciprofloxacin
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 and Chiesi to collaborate on inhaled CF drug
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
$38 million in financing for Civitas’s inhaled L-dopa program
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
Hovione granted new European patent for XCaps inhaler
The European Patent Office has granted a patent for the XCaps dry powder inhaler, Hovione has announced. The company filed for the patent in June 2011. Hovione VP Peter Villax, who co-invented the inhaler, commented, “We give our customers an edge in speed of development because we are perhaps the only independent company developing DPIs with expertise in every … [Read more...] about Hovione granted new European patent for XCaps inhaler
Insmed gets two new patents for Arikace
According to Insmed Incorporated both the US and European patent offices are granting new patents related to the company's Arikace liposomal amikacin for inhalation to treat Pseudomonas aeruginosa lung infections in cystic fibrosis patients and for non-tuberculous mycobacteria (NTM) lung infections. The company says that the US Patent and Trademark Office (USPTO) … [Read more...] about Insmed gets two new patents for Arikace
FDA advisory committee recommends approval of umeclidinium/vilanterol inhaler
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 11 to 2 in favor of approval for GSK's Anoro Ellipta umeclidinium/vilanterol dry powder inhaler for the treatment of COPD, according to GlaxoSmithKline and Theravance. The committee voted 10-3 in agreement that the safety of the UMEC/VI inhaler has been demonstrated and 13-0 on the question of … [Read more...] about FDA advisory committee recommends approval of umeclidinium/vilanterol inhaler
Asthmapolis renames itself “Propeller Health”
Inhaler monitoring specialist Asthmapolis has announced that the company has changed its name to Propeller Health. The company said that the name change reflects a widening focus that includes products for inhaled COPD medications as well as asthma medications and that Propeller plans to offer additional asthma and COPD mobile apps and additional snap-on inhaler … [Read more...] about Asthmapolis renames itself “Propeller Health”
FDA issues draft guidance on BE for fluticasone propionate/salmeterol xinafoate
The FDA has issued a draft guidance on bioequivalence recommendations for generic fluticasone propionate/salmeterol xinafoate inhalers. Notice of the draft guidance appeared in the Federal Register for September 10, 2013. According to the agency, public responses to the draft guidance will be considered before the agency responds to a December 2009 citizen petition … [Read more...] about FDA issues draft guidance on BE for fluticasone propionate/salmeterol xinafoate
BI presents new data on olodaterol and tiotropium at ERS
Boehringer Ingelheim has presented new data from several Phase 3 studies of olodaterol for the treatment of COPD and from the TIOSPIR tiotropium Respimat study at the European Respiratory Society (ERS) Annual Congress 2013. Data from the olodaterol studies shows that two tested doses of the drug delivered by the Respimat inhaler improved lung function in COPD … [Read more...] about BI presents new data on olodaterol and tiotropium at ERS