Novartis has announced that "it will initiate consultation on proposals to close" its respiratory R&D center in Horsham, UK. According to Novartis, the potential closing will affect "up to 371 roles" at the site, plus 170 contractors. The company also said that it is also withdrawing support for COPD products in the UK. In August 2012, the company reaffirmed its … [Read more...] about Novartis closer to closing UK respiratory R&D site
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Sunovion gets FDA warning letter for Brovana claims
The US FDA has issued a warning letter to Sunovion regarding claims made in four patient brochures aimed respectively at COPD patients currently using MDIs, DPIs, nebulized short acting beta agonists, or any medication giving insufficient control. According to the FDA, the brochures overstate the efficacy of Sunovion's Brovana arformoterol tartrate inhalation solution … [Read more...] about Sunovion gets FDA warning letter for Brovana claims
Copley Scientific introduces new critical flow controller for DPI testing
Copley Scientific's new TPK-R critical flow controller is designed specifically to connect to the right-hand outlet of NGI cascade impactor, allowing for efficient use of bench space, the company says. The TPK-R is a mirror image of the TPK critical flow controller but is otherwise identical, providing a constant flow rate for aerodynamic particle size distribution … [Read more...] about Copley Scientific introduces new critical flow controller for DPI testing
Tudorza Genuair approved in Canada
Health Canada has approved Almirall's Tudorza Genuair aclidinium bromide DPI for the treatment of COPD, Almirall Canada has announced. Forest Laboratories is partnered with Almirall on commercialization of the product in Canada and in the US. The inhaler was approved in the US, where it is called Tudorza Pressair, and in Europe, where it is called Eklira Genuair or … [Read more...] about Tudorza Genuair approved in Canada
Breo Ellipta now available in US
GlaxoSmithKline and Theravance have announced the availability of the Breo Ellipta fluticasone furoate/vilanterol DPI in the US. The FDA approved Breo Ellipta for the treatment of COPD in May 2013. The launch triggers a $30 million milestone payment from Theravance to GSK. GSK Senior VP of the US Respiratory Business Unit Jorge Bartolome said, “Patients and … [Read more...] about Breo Ellipta now available in US
MannKind gets PDUFA date for Afrezza
MannKind, which resubmitted its NDA for Afrezza inhaled insulin earlier this month, has announced that, "The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014." The FDA goal is to "Review and act on 90 percent of Class 2 resubmitted original … [Read more...] about MannKind gets PDUFA date for Afrezza
Bend Research adds Xcelodose micro-dosing system
Bend Research has added an Xcelodose 600S powder micro-dosing system, the company said, allowing it to fill capsules for inhalation development projects with low dose weights. The company notes that, "Precision capsule fill capability is imperative for dry powder inhalation drug products." Bend was recently acquired by Capsugel, which manufactures the Xcelodose line. … [Read more...] about Bend Research adds Xcelodose micro-dosing system
Management changes at Presspart
MDI component manufacturer Presspart has announced a round of changes to its management team. According to the company, Hans Neugebauer, who is currently Managing Director of Presspart Marsberg, will become Managing Director of Presspart Blackburn as of January 1, 2014. At that time, Dietmar Schmitz will return to his former position as the Presspart group Chief … [Read more...] about Management changes at Presspart
Milestone initiates Phase 1 trial of intranasal calcium channel antagonist
Canadian cardiovascular drug development company Milestone Pharmaceuticals has initiated a Phase 1 clinical trial of its lead product, MSP-2017 intranasal short-acting calcium channel antagonist for the treatment of paroxysmal supraventricular tachycardia (PSVT), the company announced. The randomized, double-blind, placebo-controlled crossover study will take place in … [Read more...] about Milestone initiates Phase 1 trial of intranasal calcium channel antagonist
Depomed launches Lazanda fentanyl nasal spray with patient support program
Depomed has announced a new launch of Lazanda fentanyl nasal spray in the US for the management of breakthrough pain in cancer patients who get inadequate relief from opioids. The company acquired the product from Archimedes in July 2013. Depomed is offering a new patient support system for the drug that is "designed to streamline patient access" and that includes … [Read more...] about Depomed launches Lazanda fentanyl nasal spray with patient support program