According to a spokesperson for GlaxoSmithKline, GSK is aiming to hire a total of 100 employees in 2015 and another 30-40 employees in 2016 for a new DPI assembly line at its Zebulon, NC manufacturing facility. The Zebulon plant, which manufactures and packages 65 million Advair, Breo, Ventolin, Serevent, and Flovent inhalers per year, currently has 850 … [Read more...] about GSK hiring for new DPI production line at North Carolina facility
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Adherium looks to raise at least A$20 million through IPO
New Zealand-based Smartinhaler maker Adherium (formerly Nexus6) is looking to raise a minimum of A$20 million (~ US$14.7 million) up to a maximum of A$35 million (~US25.7 million) through an initial public offering on the Australian Securities Exchange (ASX). Between 40 and 70 million shares will be offered at 50 cents/share. Proceeds are intended for … [Read more...] about Adherium looks to raise at least A$20 million through IPO
Trigemina names Shashi Kori as Chief Medical Officer
Intranasal analgesia developer Trigemina Inc. has announced the appointment of Shashidhar "Shashi" Kori as Chief Medical Officer. Trigemina's TI-114 intranasal oxytocin, is in Phase 2 development for the treatment of migraine headaches; the company is also developing an intranasal polypeptide for somatic pain. Kori was most recently Chief Medical officer at … [Read more...] about Trigemina names Shashi Kori as Chief Medical Officer
FDA approval for Breckenridge’s azelastine nasal spray
Florida-based Breckenridge Pharmaceutical has announced the launch of its azelastine HCl nasal spray, a generic version of Meda's Astelin, after receiving final FDA approval of its ANDA. The product is approved for the treatment of seasonal allergic rhinitis in patients aged 5 years and older for the treatment of vasomotor rhinitis in patients 12 years and … [Read more...] about FDA approval for Breckenridge’s azelastine nasal spray
Discovery Labs gets additional funding for development of aerosolized KL4 surfactant
Discovery Laboratories has announced the completion of a public offering that raised over $40 million as well as the receipt of a $1 million supplement from a Phase 2 Small Business Innovation Research (SBIR) grant that was initially announced in October 2014. The grant supports development of Discovery Labs' aerosolized KL4 surfactant for the treatment of … [Read more...] about Discovery Labs gets additional funding for development of aerosolized KL4 surfactant
Allergan confirms submission of ANDA for treprostinil inhalation solution
Allergan has confirmed that it submitted an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of United Therapeutics' Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension and says it believes that it is the first applicant to file. In June 2015, United Therapeutics announced that it had received … [Read more...] about Allergan confirms submission of ANDA for treprostinil inhalation solution
Indivior announces submission of NDA for naloxone nasal spray
Two days after Adapt Pharma announced that it had submitted an NDA for Narcan naloxone nasal spray, Indivior has announced that the FDA has accepted its naloxone nasal spray NDA for priority review. Indivior says that it expects its product to be the first intranasal naloxone approved by the FDA for the treatment of opioid overdose, with a response from the agency … [Read more...] about Indivior announces submission of NDA for naloxone nasal spray
Moerae Matrix announces initiation of second Phase 1 study of inhaled MK2 inhibitor
Moerae Matrix has initiated a lipopolysaccharide (LPS) challenge study of its MMI-0100 inhaled MAPKAP kinase 2 (MK2) inhibitor to evaluate its safety and tolerability in smokers, the company said. Moerae is developing MMI-0100 as a DPI for the treatment of idiopathic pulmonary fibrosis and other pulmonary diseases and has already conducted one Phase 1 study. In … [Read more...] about Moerae Matrix announces initiation of second Phase 1 study of inhaled MK2 inhibitor
Adapt Pharma submits NDA for Narcan nasal spray
Adapt Pharma has submitted an NDA for Narcan naloxone nasal spray for the treatment of opioid overdose to the FDA, the company has announced. In June 2015, Adapt said that it had initiated a rolling NDA submission. Adapt Chairman and CEO Seamus Mulligan commented, “If FDA approved, Narcan Nasal Spray would allow for the administration of naloxone - the standard … [Read more...] about Adapt Pharma submits NDA for Narcan nasal spray
Investigation into Ansun BioPharma dismissed
Inhaled vaccine developer Ansun BioPharma, formerly NexBio, has announced that the US Attorney's office investigation of misconduct by the company's former CEO and CFO has been dismissed. As part of that investigation, the US Federal Bureau of Investigation (FBI) raided the California headquarters of NexBio in August 2011. According to a January 2015 announcement … [Read more...] about Investigation into Ansun BioPharma dismissed