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Clinical trials underway for inhaled immune system stimulant

According to an announcement from the Texas A&M Health Science Center (TAMHSC), Texas-based biotech Pulmotect has initiated clinical trials of PUL-042, an inhaled immune system stimulant. In 2012, the company received a grant of over $7 million for development of PUL-042, which was designed by researchers at TAMHSC and the University of Texas MD Anderson Cancer … [Read more...] about Clinical trials underway for inhaled immune system stimulant

Acorda gets Complete Response Letter for Plumiaz diazepam nasal spray

The FDA has issued a Complete Response Letter (CRL) for Acorda Therapeutics' Plumiaz diazepam nasal spray for the treatment of cluster seizures in epilepsy patients, the company has announced. Acorda submitted a 505(b)(2) application for the product in November 2013. The company acquired the product along with its developer Neuronex in 2012. The CRL means that the … [Read more...] about Acorda gets Complete Response Letter for Plumiaz diazepam nasal spray

Survey says US payers would pay more for treatment that reduces asthma exacerbations

Decision Resources Group says that a survey of US payers found that 90 percent said they would pay a premium for a new treatment that does a significantly better job of reducing asthma exacerbations than Xolair (omalizumab). The survey results are in a report titled "Asthma (Moderate to Severe): Amid Significant Unmet Need, What Magnitude of Efficacy and Safety Do … [Read more...] about Survey says US payers would pay more for treatment that reduces asthma exacerbations

VR1 presents poster on intranasal capsaicin for headache

The makers of a homeopathic capsaicin nasal spray are presenting a poster featuring "real-world patient case series analysis supporting the use of intranasal capsaicin as an effective rapid treatment for severe headache and migraine pain" at the 2014 American Academy of Neurology (AAN) Annual Meeting. VR1, Inc. recently launched an intranasal capsaicin product, … [Read more...] about VR1 presents poster on intranasal capsaicin for headache

Novartis announces positive results from Phase 3 study of Ultibro vs Seretide (Advair)

Data from a 26-week head-to-head Phase 3 study show that the Ultibro Breezhaler indacaterol/glycopyrronium DPI produced greater improvement in the lung function of COPD patients with or without a history of moderate-to-severe exacerbations compared to Seretide Accuhaler (Advair Diskus), Novartis has announced. The company says that it intends to file a regulatory … [Read more...] about Novartis announces positive results from Phase 3 study of Ultibro vs Seretide (Advair)

Incruse Ellipta approved in Europe

GSK has announced that the European Commission has granted marketing authorization for its Incruse Ellipta umeclidinium DPI for the treatment of COPD with a dosage of 55 mcg. According to the company's announcement, launches in several European countries are anticipated by the end of the year. GSK Global Respiratory Franchise Senior VP and Head Darrell Baker … [Read more...] about Incruse Ellipta approved in Europe

Teva gets European marketing authorization for DuoResp Spiromax

The European Commission has approved Teva's DuoResp Spiromax budesonide/formoterol DPI for the treatment of asthma and COPD, the company has announced. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the DuoResp Spiromax application in February 2014. Teva Global Specialty Medicines President and CEO Rob Koremans … [Read more...] about Teva gets European marketing authorization for DuoResp Spiromax