A joint venture of Cipla, Cooper Pharma, and the Pharmaceutical Institute has constructed a new metered dose inhaler manufacturing plant in a suburb of Rabat, Morocco that opened officially as of October 14, 2018. The $6.4 million plant is situated on a 4,000 sq m site and has a capacity of 1.5 million MDIs per year. Eleven of the 15 different SKUs of MDIs … [Read more...] about New MDI manufacturing facility opened in Morocco
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Seurat Therapeutics gets $510,000 grant for development of intranasal migraine therapy
Seurat Therapeutics, a start-up biotech based at the University of Chicago, has received a grant of almost $510,000 from the National Institute of Neurological Disorders and Stroke for development of its intranasal IGF-1 for the treatment and prevention of migraines, the company said. In 2016, Seurat, then called Cephalgia, received $250,000 from the University of … [Read more...] about Seurat Therapeutics gets $510,000 grant for development of intranasal migraine therapy
CHMP adopts positive opinion regarding Bevespi Aerosphere MAA
According to AstraZeneca, the EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the marketing authorization application for the company's Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD. Bevespi Aerosphere was approved by the FDA for marketing in the US in 2016. The MDI is also … [Read more...] about CHMP adopts positive opinion regarding Bevespi Aerosphere MAA
Positive Phase 1 results for Auris Medical’s intranasal betahistine
Auris Medical has announced results from a second Phase 1 study of its intranasal betahistine in 72 healthy volunteers that demonstrated superior bioavailability compared to oral betahistine for 4 doses of the nasal formulation, with plasma exposure up to 29 times higher. Earlier this year, Auris announced results from an earlier Phase 1 study and a pre-clinical … [Read more...] about Positive Phase 1 results for Auris Medical’s intranasal betahistine
Iconovo partners with McMaster University to develop inhaled TB vaccine
Dry powder inhaler developer Iconovo has announced a partnership with McMaster University for development of a dry powder tuberculosis vaccine to be delivered via Iconovo's ICOone single-dose DPI. According to the company, the ICOone inhaler will "will be used as a test platform to facilitate future commercialization and large-scale manufacturing." The 3-year … [Read more...] about Iconovo partners with McMaster University to develop inhaled TB vaccine
Group developing inhaled antisense therapy for IPF gets funding through EuroNanoMed3
Secarna Pharmaceuticals has announced that the Inhaled Nanocarriers with Antisense Therapy for lung fibrosis (INAT) project has received a 3-year grant to fund from the ERA-Net Cofund EuroNanoMed3, part of the EC's Horizon 2020 Framework Program for Research and Innovation. Secarna is part of a consortium for INAT that includes French, German, and Belgian universities … [Read more...] about Group developing inhaled antisense therapy for IPF gets funding through EuroNanoMed3
Proveris Scientific certified to ISO 9001:2015 quality standard
Proveris Scientific, which offers a variety of products and services related to aerosol characterization, has achieved certification to the ISO 9001:2015 quality standard through October 2021, the company said. TUV Rheinland of North America, which is accredited through the ANSI-ASQ National Accreditation Board (ANAB), verified the company's conformance to the … [Read more...] about Proveris Scientific certified to ISO 9001:2015 quality standard
FDA approves sNDA for Stiolto Respimat
The FDA has approved labeling and indication changes for Boehringer Ingelheim's Stiolto Respimat tiotropium/olodaterol SMI, adding data about reductions in COPD exacerbations to the label. Stiolto Respimat (marketed in Europe as Spiolto Respimat) was initially approved in the US in 2015, with the indication limited to the treatment of airflow limitation in COPD … [Read more...] about FDA approves sNDA for Stiolto Respimat
Janssen submits MAA for esketamine nasal spray
Janssen Pharmaceutical has submitted an MAA to the EMA for its esketamine nasal spray for the treatment of treatment-resistant depression in adults with major depressive disorder, the company said. Janssen submitted an NDA for the nasal spray to the FDA in September 2018. Janssen Global Head Research & Development Mathai Mammen said, “Major depressive disorder … [Read more...] about Janssen submits MAA for esketamine nasal spray
DDL 2018 expected to be the biggest Drug Delivery to the Lungs meeting yet
Organizers of DDL 2018 say that they are expecting over 800 OINDP specialists to attend this year's iteration of the Drug Delivery to the Lungs meeting, to be held December 12-14 in Edinburgh, UK. According to DDL 2018 committee members Phil Haywood and David Harris, the exhibition hall has been reconfigured to allow up to 100 companies to introduce their latest … [Read more...] about DDL 2018 expected to be the biggest Drug Delivery to the Lungs meeting yet