According to Evoke Pharma, the FDA has issued a complete response letter in response to the company's NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. The PDUFA date for completion of review of the 505(b)(2) NDA submitted by Evoke in June 2018 was April 1, 2019. In March 2019, Evoke announced that it had received a … [Read more...] about Evoke gets CRL for Gimoti
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Nanoform names Miguel Calado as Vice Chairman of the Board
Finnish particle engineering company Nanoform has named former Hovione executive Miguel Calado as Vice Chairman of the Board. In addition to having served as CFO and VP of Finance of Hovione, Calado has also been CFO of PepsiCo International and President of International Operations at Dean Foods. Earlier this year, Nanoform named former Hovione Business … [Read more...] about Nanoform names Miguel Calado as Vice Chairman of the Board
Opiant Pharmaceuticals gets additional funding for intranasal nalmefene
Opiant Pharmaceuticals has received an additional $3 million from a 3-year grant awarded in 2018 by the National Institutes of Health’s (“NIH”) National Institute on Drug Abuse (“NIDA”) to support development of OPNT003 intranasal nalmefene for the treatment of opioid overdose. The company previously received $2.6 million from the grant, which is worth up to a total … [Read more...] about Opiant Pharmaceuticals gets additional funding for intranasal nalmefene
Cip Tec and Pulmatrix agree on terms for acquisition of rights to Pulmazole itraconazole DPI for ABPA
Pulmatrix announced that it has signed an agreement with Cipla subsidiary Cipla Technologies (Cip Tec) that "lays the groundwork" for Cip Tec to acquire the rights to Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients. A definitive deal is expected in the 2nd quarter of 2019, … [Read more...] about Cip Tec and Pulmatrix agree on terms for acquisition of rights to Pulmazole itraconazole DPI for ABPA
MannKind gets first milestone payment from United Therapeutics for treprostinil DPI development
MannKind Corporation has announced that it has received a $12.5 million milestone payment from United Therapeutics for the first milestone related to development of a treprostinil Technosphere (TreT) DPI for the treatment of pulmonary arterial hypertension. The company did not specify what milestone had been achieved. United Therapeutics and MannKind announced the … [Read more...] about MannKind gets first milestone payment from United Therapeutics for treprostinil DPI development
3M Drug Delivery Systems opens new R&D Inhalation Centre of Excellence
3M Drug Delivery Systems will officially open a new 1,300 sq m R&D Inhalation Centre of Excellence on is Charnwood Campus in Loughborough, UK this month, the company said. According to 3M DDS, the new building, which took 2 years to complete, will house 120 R&D employees. Leicester and Leicestershire Enterprise Partnership Chair Kevin Harris said, “I’m … [Read more...] about 3M Drug Delivery Systems opens new R&D Inhalation Centre of Excellence
VistaGen presents new data from Phase 3 study of PH94B nasal spray for social anxiety disorder
VistaGen Therapeutics has presented new data from a Phase 3 study of PH94B nasal spray for the treatment of social anxiety disorder (SAD) at the 2019 Anxiety and Depression Association of America (ADAA) Annual Conference. VistaGen acquired the rights to PH948B from Pherin Pharmaceuticals in September 2018. According to Vistagen, patients who received PH94B … [Read more...] about VistaGen presents new data from Phase 3 study of PH94B nasal spray for social anxiety disorder
Savara begins Phase 2a trial of Molgradex for the treatment of NTM lung infection in CF patients
Savara has announced the initiation of the Phase 2a ENCORE study of its Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infection in cystic fibrosis patients. The company is also developing Molgradex for the treatment of NTM lung infections in non-CF patients and … [Read more...] about Savara begins Phase 2a trial of Molgradex for the treatment of NTM lung infection in CF patients
FDA approves Duaklir Pressair for the treatment of COPD
The FDA has approved Duaklir Pressair aclidinium bromide/formoterol fumarate DPI for the treatment of COPD, Circassia Pharmaceuticals has announced. Circassia said in August 2018 that the FDA had accepted the NDA for Duaklir and an sNDA for Tudorza Pressair aclidinium bromide DPI, which has also been approved. The company says that it plans to launch Duaklir in the … [Read more...] about FDA approves Duaklir Pressair for the treatment of COPD
Biohaven initiates Phase 2/3 study of BHV-3500 intranasal therapy for migraine
Biohaven Pharmaceutical said that it has initiated a Phase 2/3 study of its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist for the treatment of migraine. The company announced positive results from a Phase 1 study of BHV-3500 in February 2019. The trial will compare 5, 10, and 20 mg doses of BHV-3500 delivered by Aptar Pharma's Unit … [Read more...] about Biohaven initiates Phase 2/3 study of BHV-3500 intranasal therapy for migraine