Generic Equivalent of Brovana® Hits the Market
According to Cipla Limited, the FDA has issued final approval for its Abbreviated New Drug Application for its generic equivalent of Brovana. The company’s Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is being approved as a long-term maintenance treatment for bronchoconstriction in patients with COPD. The long-acting beta-2 adrenergic agonist is used twice daily, in the morning and evening. The company notes the product is now available for shipping. Read More
Drug for Severe Asthma Gets FDA Go-Ahead
The FDA accepted a new Biologics License Application (BLA) and granted Priority Review for tezepelumab to treat asthma. The drug, which Amgen is developing in collaboration with AstraZeneca, outperformed a placebo in clinical trials involving patients with uncontrolled asthma. “Severe asthma is a challenging, complex disease for physicians and millions of patients and has a high unmet medical need,” said David M. Reese, MD, executive vice president of research and development at Amgen. “We are proud to advance an innovative, first-in-class monoclonal antibody that targets the top of the inflammatory cascade and represents a potentially transformative treatment option for a broad population of patients with severe asthma.” Read More
NHLBI Takes Crowdsourcing Approach to Improve Supplemental Oxygen Delivery
HeroX, the social network for innovation, is conducting a new crowdsourcing competition on behalf of the National Heart, Lung and Blood Institute. The competition aims to find new and easier-to-use options for patients who require supplemental oxygen. The “Air You Wear Challenge” is being conducted in two phases. In phase one, up to eight teams with the most promising ideas will receive up to $50,000 to develop a prototype of their design or present a concept demonstration. In phase two, three teams will receive first, second, and third prizes of $60,000, $30,000, and $10,000, respectively, to further their work. Read More
Pilot Project to Test Wearable Technology for Asthma
Researchers from the University of Alberta in Canada are launching a pilot project to test the ability of new wearable technology from Health Care Originals to monitor symptoms and warn of impending exacerbations in people with asthma. Called ADAMM-RSM, the device can collect data on the patient’s respiratory rate, heart rate, temperature, coughing, wheezing, and activity level over eight or more hours a day. It’s worn on the torso, placed on the chest, side, or back to suit patient comfort. If the pilot project proves successful, the investigators plan to conduct additional trials focusing on specific populations and larger sample sizes. They believe other respiratory conditions are likely to benefit from the technology as well. Read More
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