The organizers of RDD 2014 have announced that the 2014 winner of the Charles G. Thiel Award is Dieter Hochrainer of Boehringer Ingelheim. The award was presented by Peter Byron at the opening of the conference, which is taking place in Fajardo, Puerto Rico. The award, sponsored by 3M Drug Delivery Systems and an endowment at Virginia Commonwealth University, is … [Read more...] about 2014 Charles G. Thiel award presented to Dieter Hochrainer of Boehringer Ingelheim
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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
FDA approves Incruse Ellipta for COPD
Less than a week after the approval of GSK's Incruse Ellipta umeclidinium DPI in Europe, the company has announced that the FDA has approved the product for the treatment of COPD and it expects to launch Incruse Ellipta in the US by the end of the year. GSK submitted the NDA for umeclidinium monotheraphy at the end of April 2013. GSK Global Respiratory Franchise … [Read more...] about FDA approves Incruse Ellipta for COPD
Medivir launches Adasuve in four Nordic countries
Medivir has announced the launch of Adasuve inhaled loxapine for the treatment of agitation in schizophrenic or bipolar patients in Sweden, Norway, Finland, and Denmark. Medivir acquired the rights to commercialize Adasuve in all five Nordic countries from Grupo Ferrer in September 2013. Medivir Executive VP, Commercial, Henrik Krook, commented, “It is gratifying … [Read more...] about Medivir launches Adasuve in four Nordic countries
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