Biohaven Pharmaceuticals said that it has filed an investigational new drug application for its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist, which it is developing for the prevention and treatment of migraine. BHV-3500, which Biohaven licensed from Bristol-Myers Squibb, is delivered using Aptar Pharma's unit dose system. … [Read more...] about Biohaven submits IND for intranasal CGRP receptor antagonist for migraine
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Vectura inhaled product revenues up more than 7% in first half of 2018
Vectura has announced that revenues from inhaled drugs rose 7.1% in the first half of 2018, with Flutiform revenues up 3.1% compared to the first half of 2017 and up 6.1% compared to the second half of 2017. Total revenue for the six months was up 1.4%. The company also said that results from Phase 2 studies of VR647 nebulized budesonide inhalation suspension … [Read more...] about Vectura inhaled product revenues up more than 7% in first half of 2018
Napp Pharmaceuticals launches Mundipharma’s Flutiform k-haler in the UK
According to Mundipharma, Napp Pharmaceuticals has launched the company's Flutiform fluticasone propionate/formoterol fumarate k-haler breath-activated MDI in the UK. The launch is the first in Europe since Flutiform k-haler was approved for the treatment of asthma in patients aged 12 and older through the decentralized procedure in October 2017. Mundipharma … [Read more...] about Napp Pharmaceuticals launches Mundipharma’s Flutiform k-haler in the UK
Consort Medical to manufacture Opiant’s nalmefene nasal spray
Consort Medical subsidiaries Aesica and Bespak will manufacture Opiant Pharmaceuticals' OPNT003 nalmefene nasal spray, the companies said. Earlier this year, Opiant announced that it would develop OPNT003 for the treatment of opioid overdose using the 505(b)(2) pathway, and the company has been awarded a grant worth around $7.4 million by the National Institutes … [Read more...] about Consort Medical to manufacture Opiant’s nalmefene nasal spray
Glenmark’s generic version of Seretide Accuhaler approved in Germany
Glenmark Pharmaceuticals announced that it has received marketing approval from German authorities for its generic version of Seretide Accuhaler and said that the product will be marketed in Germany as "Salflutin." The company acquired development and marketing rights to the fluticasone/salmeterol DPI from Celon for 15 countries, including the UK, Germany, … [Read more...] about Glenmark’s generic version of Seretide Accuhaler approved in Germany
Roivant acquires global rights to Patara’s inhaled cromolyn sodium
Roivant Sciences has acquired global rights to Patara Pharma's PA101 cromolyn sodium inhalation solution for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), the company said. The inhalation solution, which will now be called RVT-1601, is delivered via the PARI eFlow nebulizer. In 2016, Patara announced positive results from a … [Read more...] about Roivant acquires global rights to Patara’s inhaled cromolyn sodium
United Therapeutics and MannKind partner for development of treprostinil DPI for PAH
United Therapeutics will pay MannKind Corporation $45 million up front and up to $50 million in milestone payments, plus potential double-digit royalties for a worldwide exclusive licensing and collaboration agreement for development and commercialization of a treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH), the companies said. In June … [Read more...] about United Therapeutics and MannKind partner for development of treprostinil DPI for PAH
Janssen submits NDA for esketamine nasal spray
Johnson & Johnson subsidiary Janssen Pharmaceutical has submitted an NDA for esketamine nasal spray for the treatment of treatment-resistant depression in adults, the company said. Janssen said that it plans to submit an MAA to the EMA for esketamine nasal spray for the same indication later this year. In May 2018, Janssen published positive results from a Phase 3 … [Read more...] about Janssen submits NDA for esketamine nasal spray
Merxin signs deal for development of tiotropium/olodaterol product using its MRX004 SMI
Device developer Merxin has announced that a European generics company has acquired exclusive worldwide rights for development of a tiotropium/olodaterol product for the treatment of COPD using Merxin's MRX004 softmist inhaler. Boehringer Ingelheim markets its tiotropium/olodaterol soft mist inhaler as Stiolto Respimat in the US and Spiolto Respimat in … [Read more...] about Merxin signs deal for development of tiotropium/olodaterol product using its MRX004 SMI
Glenmark licenses tiotropium DPI in Western Europe
Glenmark Pharmaceuticals said that it has acquired an exclusive license to market a generic tiotropium bromide dry powder inhaler in Western Europe. The DPI, a generic version of Boehringer Ingelheim's Spiriva Handihaler for the treatment of COPD, is the second inhaler Glenmark has licensed for the European market. In 2015, Glenmark announced that it had entered … [Read more...] about Glenmark licenses tiotropium DPI in Western Europe