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Phase 3 trial of VR475 inhalation suspension fails to meet primary endpoint, Vectura discontinues development

Vectura has announced that a Phase 3 study of VR475 budesonide inhalation suspension for the treatment of severe uncontrolled asthma in adult and adolescent patients failed to meet its primary endpoint. As a result, the company said that it would discontinue development of VR475 (formerly known as Favolir), which it acquired when it acquired Activaero in … [Read more...] about Phase 3 trial of VR475 inhalation suspension fails to meet primary endpoint, Vectura discontinues development

InCarda Therapeutics raises $42 million, initiates Phase 2 trial of inhaled flecainide

InCarda Therapeutics has announced the completion of an oversubscribed $42 million Series B financing that will fund a Phase 2 study of InRhythm inhaled flecainide for the treatment of recent-onset paroxysmal atrial fibrillation (PAF). The financing round was led by Sofinnova and HealthCap, both new investors along with Deerfield Management. In 2015, InCarda raised … [Read more...] about InCarda Therapeutics raises $42 million, initiates Phase 2 trial of inhaled flecainide

Vectura to develop generic versions of Ellipta DPIs with Hikma

Vectura and Hikma Pharmaceuticals have announced a deal for development and commercialization of generic versions of GSK's Ellipta dry powder inhalers. Hikma will pay Vectura $15 million up front, $5 million at the start of clinical manufacturing for the first product, up to $75 million in development milestones, a percentage of distributable share of net profit on … [Read more...] about Vectura to develop generic versions of Ellipta DPIs with Hikma

Covis Pharma acquires additional rights to Alvesco, Omnaris, and Zetonna from AstraZeneca

AstraZeneca has announced that Covis Pharma will pay $350 million up front for the rights to market Alvesco ciclesonide MDI and the ciclesonide nasal spray Omnaris and nasal MDI Zetonna outside of the US. The deal also includes up to $21 million in potential payments conditioned on sales over the 4 years beginning in 2019. Covis acquired US rights to Alvesco, Omnaris, … [Read more...] about Covis Pharma acquires additional rights to Alvesco, Omnaris, and Zetonna from AstraZeneca

GSK opens new Ellipta API manufacturing facility in Scotland

According to the Scottish government, a new manufacturing facility built by GSK in Montrose to produce APIs for its Ellipta dry powder inhalers officially opened on October 22, 2018, with Scottish First Minister Nicola Sturgeon in attendance. Sturgeon commented, “This new facility is testament to GSK’s commitment to Montrose and reinforces the region’s position … [Read more...] about GSK opens new Ellipta API manufacturing facility in Scotland

Adapt and Opiant file suit in response to Perrigo ANDA for naloxone nasal spray

Perrigo said that Adapt Pharma and Opiant Pharmaceuticals have initiated patent litigation in the United States District Court for the District of New Jersey in regards to Perrigo's recently filed ANDA for a generic version of Narcan naloxone nasal spray for the treatment of opioid overdose. Adapt Pharma licensed naloxone nasal spray from Opiant (then called … [Read more...] about Adapt and Opiant file suit in response to Perrigo ANDA for naloxone nasal spray

Galecto Biotech raises €79 million for Phase 2/3 study of its inhaled galectin-3 inhibitor

Galecto Biotech announced that it raised €79 million in a series C financing round that will be used to fund a Phase 2/3 study of its TD139, an inhaled galectin-3 inhibitor, for the treatment of idiopathic pulmonary fibrosis (IPF). New investors included Ysios Capital, OrbiMed, HBM Healthcare Investments, OrbiMed Israel, Maverick Ventures, Seventure Partners, and … [Read more...] about Galecto Biotech raises €79 million for Phase 2/3 study of its inhaled galectin-3 inhibitor