Avadel Specialty Pharmaceuticals, which marketed Noctiva desmopressin nasal spray in the US, has filed for Chapter 11 bankruptcy, parent company Avadel Pharmaceuticals announced. Less than a year after launching Noctiva in the US, Avadel said that it will no longer market the product. Noctiva was approved by the FDA in March 2017 for the treatment of nocturnal … [Read more...] about Avadel Pharmaceuticals drops Noctiva nasal spray
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Grandpharma acquires Chinese rights to Ryaltris nasal spray
Glenmark Pharmaceuticals announced that it has agreed to a licensing deal giving Grandpharma exclusive rights to commercialize Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray in China. The company recently announced that Yuhan had acquired South Korean rights to Ryaltris in South Korea. In July 2018, Glenmark said that it had reached an agreement … [Read more...] about Grandpharma acquires Chinese rights to Ryaltris nasal spray
Senzer inhaler wins second design award
Senzer's Systemic inhaled Delivery Device (SiDD) has won an iF Design Award in the Medicine/Health product category, the company said. The inhaler also recently won a 2018 Good Design award in the medical category. The company is developing several cannabinoid products, including dronabinol and cannabidiol inhalers, based on the breath activated SiDD platform, … [Read more...] about Senzer inhaler wins second design award
AIT Therapeutics gets milestone payment from Circassia on completion of pre-submission meeting for AirNOvent
AIT Therapeutics said that it has received a $3.15 million milestone payment from Circassia Pharmaceuticals after successful completion of a pre-submission meeting with the FDA for AirNOvent nitric oxide delivery system. Circassia recently announced that it had acquired US and Chinese rights to the product. In a separate announcement, Circassia said that it will … [Read more...] about AIT Therapeutics gets milestone payment from Circassia on completion of pre-submission meeting for AirNOvent
Biohaven announces plans for Phase 2 trial of BHV-3500 intranasal migraine drug
Biohaven Pharmaceutical announced the successful completion of a Phase 1 trial of its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist and said that the company plans to initiate a Phase 2 efficacy trial in the second quarter of 2019. Biohaven CEO Vlad Coric said, "We are excited to report that intranasal administration of BHV-3500 in … [Read more...] about Biohaven announces plans for Phase 2 trial of BHV-3500 intranasal migraine drug
Acorda Therapeutics names Peter S. Carbone as Senior VP, Quality
Acorda Therapeutics has announced the appointment of Peter S. Carbone as Senior VP, Quality. Carbone was most recently VP of Quality Solids Americas & Special Technologies at Novartis and previously held executive positions at Amgen and Allergan. The FDA approved Acorda's Inbrija levodopa DPI for the treatment of OFF episodes in Parkinson’s disease patients in … [Read more...] about Acorda Therapeutics names Peter S. Carbone as Senior VP, Quality
Mylan announces plans for launch of Wixela Inhub, its generic version of Advair Diskus
One day after the FDA announced that it has approved Mylan's ANDA for Wixela Inhub, a generic version of Advair Diskus fluticasone propionate/salmeterol DPI, Mylan has announced that it will launch the product by the end of February. The FDA approved Wixela Inhub in three strengths for the treatment of COPD and for the treatment of asthma in patients aged 4 years and … [Read more...] about Mylan announces plans for launch of Wixela Inhub, its generic version of Advair Diskus
Tetra Bio-Pharma files patent application for inhaled cannabis drug
Canadian cannabinoid developer Tetra Bio-Pharma says that it has filed a patent application covering technology related to its PPP001 cannabis drug pellet. According to the company, the patent application covers fabrication methods and composition of matter. Tetra's announcement says, "research demonstrated that the class II medical device or pipe used to combust … [Read more...] about Tetra Bio-Pharma files patent application for inhaled cannabis drug
FDA approves Mylan’s generic version of Advair Diskus
The FDA announced that it has approved Mylan's generic version of Advair Diskus fluticasone propionate/salmeterol DPI for the treatment of asthma in patients four years old and older and for the treatment of COPD. Three strengths were approved: FP 100 μg/salmeterol 50 μg, FP 250 μg/salmeterol 50 μg and FP 500 μg/salmeterol 50 μg. In 2013, the FDA issued a draft … [Read more...] about FDA approves Mylan’s generic version of Advair Diskus
Aradigm announces submission of responses to EMA Day 120 questions
Aradigm Corporation, which submitted an MAA for its dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients in March 2018, has announced that it submitted responses to EMA Day 120 questions on January 23, 2019. The company said that it anticipates receiving a Day 180 list of … [Read more...] about Aradigm announces submission of responses to EMA Day 120 questions