The Canadian Agency for Drugs and Technology in Health (CADTH) has issued a call for patient input regarding GSK's Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma. According to the announcement, the agency has received notice of a pending submission and is seeking input from patient groups for purposes of a Common Drug Review. According … [Read more...] about Canadian agency calls for patient input on Breo Ellipta
Regulatory
Israeli patent issued for AAT pulmonary delivery system
The Israeli Patent Office has issued Patent No. 193318, “System for Pulmonary Delivery of Alpha-1 Proteinase Inhibitor,” to Kamada and PARI Pharma, Kamada has announced. The patent relates to delivery of Kamada’s inhaled alpha-1 proteinase inhibitor (AAT) using a custom eFlow nebulizer from PARI. Kamada CEO Amir London commented, “We continue to fortify our … [Read more...] about Israeli patent issued for AAT pulmonary delivery system
FDA approves Zomig nasal spray for pediatric patients
Impax Specialty Pharma has received approval from the FDA to market Zomig zolmitriptan nasal spray for the treatment of migraine in patients 12-17 years of age, the company says. Impax acquired the US rights to Zomig nasal spray from AstraZeneca in 2012. Impax Laboratories President and CEO Fred Wilkinson commented, "Treatment options have been limited for … [Read more...] about FDA approves Zomig nasal spray for pediatric patients
United Therapeutics says it will defend Tyvaso patents
According to United Therapeutics, the company has received notice that Watson Laboratories, a subsidiary of Allergan, has submitted an Abbreviated New Drug Application (ANDA) for a generic version of United Therapeutics' Tyvaso treprostinil inhalation solution. The notice letter cites three patents, US Patent Nos. 6,521,212; 6,756,033; and 8,497,393 as invalid … [Read more...] about United Therapeutics says it will defend Tyvaso patents
Adapt Pharma initiates rolling NDA submission for intranasal naloxone
Adapt Pharma has initiated a rolling NDA submission for intranasal naloxone for the treatment of opioid overdose, the company said. Adapt licensed the intranasal naloxone formulation from Lightlake Therapeutics in December 2014 and received Fast Track Designation for the product from the FDA in February 2015. Lightlake CEO Roger Crystal said, "This is a very … [Read more...] about Adapt Pharma initiates rolling NDA submission for intranasal naloxone
FDA approves Stiolto Respimat for the treatment of COPD
According to Boehringer Ingelheim, the FDA has approved its tiotropium bromide/olodaterol soft mist inhaler for the treatment of COPD. The company filed an NDA for the product, which will be marketed as Stiolto Respimat Inhalation Spray, in August 2014. New data analyses from Phase 3 studies showing improved lung function for patients using the combination … [Read more...] about FDA approves Stiolto Respimat for the treatment of COPD
AIT’s nitric oxide product for CF gets European orphan designation
Advanced Inhalation Therapies (AIT) has announced that its AIT-CF high dose inhaled formulation of nitric oxide (NO) for the treatment of cystic fibrosis has been granted orphan medical product designation by the European Commission. In February 2015, the company announced that the product had received orphan drug designation from the FDA in late 2014. AIT Chief … [Read more...] about AIT’s nitric oxide product for CF gets European orphan designation
FDA approves Breo Ellipta for the treatment of asthma in adults
The FDA has approved GSK's supplemental NDA for the Breo Ellipta fluticasone furoate/vilanterol DPI, allowing GSK to market the inhaler for the treatment of asthma in patients aged 18 years and older. Breo Ellipta was approved by the FDA for the treatment of COPD in May 2013. In March 2015, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug … [Read more...] about FDA approves Breo Ellipta for the treatment of asthma in adults
Aptar Pharma gets license for preservative free multidose nasal devices in China
Aptar Pharma has announced that the Chinese State Food and Drug Administration (SFDA) has issued the company an import license for its preservative-free multi-dose opthalmic and nasal devices in accordance with regulations that require “Examination and approval for packaging materials and containers in direct contact with drugs” prior to marketing. Aptar's APF … [Read more...] about Aptar Pharma gets license for preservative free multidose nasal devices in China
PARI Pharma’s Vantobra inhalation solution approved in Europe
PARI Pharma has received European marketing authorization for its Vantobra 170 mg tobramycin/1.7 ml inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 and older, the company said. Vantobra is delivered via the Tolero nebulizer and is packaged together with the device. PARI Pharma submitted the marketing authorization … [Read more...] about PARI Pharma’s Vantobra inhalation solution approved in Europe