Advanced Inhalation Therapies (AIT), which is developing inhaled nitric oxide therapies for cystic fibrosis and other indications, has filed a request to withdraw its registration statement for an initial public offering. The company announced its initial filing for the IPO in August 2015, saying that it planned to raise up to $36 million to support Phase 2 … [Read more...] about Advanced Inhalation Therapies files to withdraw IPO
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Sunovion announces results of long-term safety study of glycopyrrolate inhalation solution
Sunovion has announced results from the Phase 3 GOLDEN-5 48-week safety study of SUN-101 glycopyrrolate inhalation solution in patients with moderate-to-very severe COPD. According to the company, the data show that SUN-101 was well tolerated, and the incidence of adverse events was similar to that of the active comparator, Spiriva Handihaler. The study enrolled 1,087 … [Read more...] about Sunovion announces results of long-term safety study of glycopyrrolate inhalation solution
McMaster researchers developing intranasal vaccine against chlamydia
Researchers at the Michael G. DeGroote Institute for Infectious Disease Research at McMaster University have published an article in the journal Vaccine describing promising results from a study of their intranasal BD584 chlamydial antigen against Chlamydia trachomatis, which can cause eye infections called trachoma that may result in blindness and can also cause … [Read more...] about McMaster researchers developing intranasal vaccine against chlamydia
Fidelity increases its holding in Adherium to 10%
Smartinhaler maker Adherium has announced an upcoming $8 million AUD ($6 million USD) share placement to Fidelity International, increasing Fidelity's holdings in the company to 10%. The shares will be issued on July 26, 2016. According to Adherium, the purpose of the placement was to raise funds for working capital. Adherium CEO Garth Sutherland commented, … [Read more...] about Fidelity increases its holding in Adherium to 10%
Evoke’s Phase 3 trial of intranasal metoclopramide fails to meet primary endpoint
Evoke Pharma has announced that a Phase 3 trial of EVK-001 intranasal metoclopramide in 205 female diabetic gastroparesis patients failed to achieve its primary endpoint, which was improvement of symptoms at Week 4. EVK-001 and placebo treatment both produced similar improvement at Week 4. Results from a Phase 2b study announced in January 2014 had shown superior … [Read more...] about Evoke’s Phase 3 trial of intranasal metoclopramide fails to meet primary endpoint
Positive Phase 1 results for Pulmatrix’s PUR0200 DPI
Pulmatrix has announced topline results from the Phase 1 bioavailability trial of Pulmatrix's PUR0200 generic tiotropium DPI initiated in January 2016 and completed in May 2016. The company had previously announced positive Phase 1b results for a trial of PUR0200 in COPD patients. The 7-way crossover study involved 42 healthy subjects who each received a dose of … [Read more...] about Positive Phase 1 results for Pulmatrix’s PUR0200 DPI
Windtree Therapeutics gets $1 million for aerosolized KL4 surfactant development
Windtree Therapeutics (formerly Discovery Laboratories) said that it has received an additional $1 million from a Phase 2 Small Business Innovation Research (SBIR) grant initially announced in October 2014. The grant, with a total potential value of $3 million, supports development of the company's aerosolized KL4 surfactant as a treatment for radiation-induced lung … [Read more...] about Windtree Therapeutics gets $1 million for aerosolized KL4 surfactant development
FDA approves nasal spray dental anesthetic
The FDA has approved St. Renatus's Kovanaze tetracaine HCl and oxymetazoline HCl nasal spray, the company announced. The product is approved for regional anesthesia for adults and children weighing 40 kg or more who are having work done on the upper incisors, canines, or premolars. The company announced positive results from a Phase 3 study of the nasal spray in … [Read more...] about FDA approves nasal spray dental anesthetic
H&T Presspart opens Latin American sales office
Inhaler component manufacturer H&T Presspart has announced the opening of a new sales office in Montevideo, Uruguay to serve customers in the South and Central American region. In addition, Jesus Polanco, formerly Business Development Manager at H&T Presspart Tarragona has been appointed Sales and Business Development Manager Latin America, effective immediately, … [Read more...] about H&T Presspart opens Latin American sales office
Health Canada allows temporary importation of naloxone nasal spray from the US
While Health Canada conducts an expedited review of a new drug submission (NDS) for naloxone nasal spray, Minister of Health Jane Philpott has signed an Interim Order temporarily allowing naloxone nasal spray imported from the US to be sold in Canada. Currently, the only form of naloxone available in Canada is injectable. Adapt Pharma submitted the NDS to Health … [Read more...] about Health Canada allows temporary importation of naloxone nasal spray from the US