Boehringer Ingelheim has presented data from a 6-week Phase 3 study of its tiotropium/olodaterol soft mist inhaler in 219 moderate to severe COPD patients showing that patients using the fixed dose combination had significantly greater improvements in FEV1 than those using either placebo or tiotropium or olodaterol monotherapy. Safety data were similar for the … [Read more...] about Positive Phase 3 results for BI’s tiotropium/olodaterol Respimat
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MVIC to develop inhaled drug for Chinese pharma company
According to Swedish CRO Medicon Valley Inhalation Consortium (MVIC), the organization has entered into a 2-year, €1.6 million contract with a Chinese company to develop an inhaled generic drug for the treatment of asthma and COPD. MVIC will develop a new inhalation product for asthma and COPD. The new contract brings MVIC's total orders over the past year to €2.5 … [Read more...] about MVIC to develop inhaled drug for Chinese pharma company
Discovery Labs announces two hires to oversee Aerosurf development
Discovery Laboratories has hired former AstraZeneca Senior Medical Director Steve Simonson as VP, Clinical Development and former PARI VP and Director of Product Technology Lawrence Weinstein as VP, Medical Device Development, the company said. The new hires, both of whom have extensive OINDP experience, will oversee development of the Aerosurf aerosolized KL4 … [Read more...] about Discovery Labs announces two hires to oversee Aerosurf development
Insmed announces additional positive results for Arikayce
Insmed has presented additional positive results from the open label portion of a Phase 2 trial of Arikayce inhaled liposomal amikacin for the treatment-resistant nontuberculous mycobacterial (NTM) lung infections at the American Thoracic Society annual meeting. Previously announced results from the trial were mixed. The 84-day open label phase involved 78 of the … [Read more...] about Insmed announces additional positive results for Arikayce
Aradigm’s Pulmaquin gets QIDP status
Aradigm has announced that the FDA has designated its Pulmaquin inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis patients as a Qualified Infectious Disease Product (QIDP). QIDP status makes the product eligible for the FDA's Fast Track expedited review program. Aradigm CEO Igor Gonda said, "We are very … [Read more...] about Aradigm’s Pulmaquin gets QIDP status
Reckitt Benckiser to co-develop naloxone nasal spray
Reckitt Benckiser Pharmaceuticals will co-develop a unit-dose naloxone nasal spray for the reversal of opioid overdoses with Kentucky-based AntiOp, the company has announced. The only detail of the deal that was released is that the agreement includes an option for Reckitt Benckiser to acquire all marketing rights to the nasal spray if approved. Reckitt Benckiser … [Read more...] about Reckitt Benckiser to co-develop naloxone nasal spray
Kamada pivotal study of inhaled AAT fails to meet primary endpoint
Kamada has announced that preliminary results from its Phase 2/3 pivotal trial of its inhaled Alpha-1 Antitrypsin (AAT) therapy showed no difference between inhaled AAT and placebo in “time to first moderate or severe exacerbation,” the primary endpoint. The 50-week study involved 168 patients. The company said that the frequency of severe exacerbations in patients … [Read more...] about Kamada pivotal study of inhaled AAT fails to meet primary endpoint
Skyepharma provides updates on Flutiform
As part of an interim management statement, Skyepharma has said that the launch of its Flutiform fluticasone/formoterol MDI in Spain could take place by the end of 2014, triggering a milestone payment of €2.0 million. The company also noted that it has received a €3.0 million milestone payment for the launch of the product in France in the first quarter of 2014. In … [Read more...] about Skyepharma provides updates on Flutiform
FDA approves Apotex’s generic budesonide nasal spray
Apotex says that it launched a generic budesonide nasal spray in the US on May 13, 2014 following the previous day's approval of the product by the FDA. The new product, with a strength of 32 mcg/spray, is a generic equivalent for AstraZeneca's Rhinocort Aqua. Apotex's suggested average wholesale price is $160.53, which appears to be similar to the retail price of … [Read more...] about FDA approves Apotex’s generic budesonide nasal spray
FDA accepts Teva’s supplemental application for pediatric QNASL
Teva has announced the FDA's acceptance of its supplemental NDA for a low-dose formulation of QNASL beclomethasone dipropionate HFA nasal spray for the treatment of allergic rhinitis in children aged 4-11. The FDA approved QNASL for the treatment of seasonal and perennial allergic rhinitis in patients 12 and older in March 2012. Teva Senior VP Global Respiratory … [Read more...] about FDA accepts Teva’s supplemental application for pediatric QNASL