US-based Cannabis Science has announced that it "will release an inhalation medication for those suffering asthma/COPD for use in patient nebulizers." According to the company, the product would be available "in states where marijuana is legal on a national basis." The announcement does not specify when or how such a release would occur but it asserts that over … [Read more...] about Cannabis Science says it will “release” a CBD/THC product for asthma and COPD patients in US
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Mast Therapeutics initiates Phase 2 study of AIR001
According to Mast Therapeutics the first patient has been enrolled in a Phase 2 study of its AIR001 sodium nitrite inhalation solution in patients with heart failure with preserved ejection fraction (HFpEF). The multicenter, randomized, double-blind, placebo-controlled is expected to enroll 100 patients. The company announced earlier this year that the INDIE-HFpEF … [Read more...] about Mast Therapeutics initiates Phase 2 study of AIR001
Sunovion submits NDA for SUN-101/eFlow glycopyrrolate for COPD
Sunovion has submitted a new drug application to the FDA for its SUN-101/eFlow glycopyrrolate for the treatment of COPD, the company said. The company recently reported positive results from the GOLDEN-5 long-term safety study of SUN-101/eFlow and had previously reported data from the GOLDEN-3 and GOLDEN-4 efficacy trials that are being used to support the NDA. … [Read more...] about Sunovion submits NDA for SUN-101/eFlow glycopyrrolate for COPD
Vectura sues GSK for patent infringement related to Ellipta licensing agreement
Vectura has filed a patent infringement suit against GlaxoSmithKline after GSK said that it would not exercise its option for additional patent licenses for various Ellipta DPI products under a 2010 agreement. Many of the patents covered in the agreement expire in 2016. Vectura says that GSK is infringing on US Patent No. 8,303,991, titled "Method of making … [Read more...] about Vectura sues GSK for patent infringement related to Ellipta licensing agreement
Advanced Inhalation Therapies files to withdraw IPO
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
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