European regulatory authorities gave Teva a positive opinion for its DuoResp Spiromax inhalation powder, designed to treat asthma and chronic obstructive pulmonary disease. With the recommendation from the Committee for Medicinal Products for Human Use, Teva hopes to have final approval within a few months.
While it's still unclear how long copycats will take to make a serious dent in GlaxoSmithKline's respiratory franchise once generic competition inevitably erodes sales of the $8.8 billion-selling Advair, Glaxo may soon have a new building block with European regulators' new recommendation for combo med Anoro.
3M Drug Delivery Systems has joined forces with the Delaware outfit Invion to develop inhaled drugs for inflammatory airway diseases.
Massachusetts-based dry-powder specialist Pulmatrix welcomed successful early-stage results for its bronchodilator treatment for chronic obstructive pulmonary disorder, which makes use of its novel lung delivery system iSPERSE.
Boehringer Ingelheim has won over European regulators with its latest COPD therapy, following a favorable FDA panel vote that set the stage for U.S. approval and entrance into a huge but crowded market.
Novartis is launching the expected blockbuster into a rapidly expanding but increasingly competitive market as established players and newcomers vie for their piece of the action.
GlaxoSmithKline and Theravance have nailed down a solid majority of FDA panel votes in favor of marketing their new COPD therapy Anoro Ellipta. The outside experts voted 11 to 2 this afternoon to endorse the therapy, opening the door to the first of several new drug that will likely wind up duking it out in a tough fight for market share.
Over the weekend some of the world's largest drug developers rolled out new data on their late-stage COPD drugs, staying upbeat despite a growing sense among some analysts that many of these new drugs will find it hard to offer much in the way of a significant improvement for patients.
The delay could interfere with their plans to compete against rival drugs that could get to market first.
3M licensed its dry powder drug delivery device for asthma and chronic obstructive pulmonary disease to Adamis for an undisclosed amount, granting the smaller company worldwide rights to bolster its own line of delivery devices.