Acorda Therapeutics (NSDQ:ACOR) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are […]
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Ocular Therapeutix’s ophthalmic device gains Medicare coverage early
Ocular Therapeutix (NSDQ:OCUL) said today that the Centers for Medicare and Medicaid Services has assigned a specific and permanent reimbursement J-code for its Dextenza ophthalmic insert, which is approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The code assigned to Dextenza through the Healthcare Common Procedure Coding System will become effective […]
FDA issues new postmarket guidance for drug-device products
The FDA has released final postmarket guidance for manufacturers of drug-device combination products. The guidance outlines how the agency expects manufacturers of combination products and those that make constituent parts of drug-device combinations to report adverse events and product malfunctions. Combination-product manufacturers will have five working days to report adverse events that require remedial action […]
Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
Taris Biomedical has announced the dosing of the first patient in a study of its TAR-200 system plus a programmed immune checkpoint inhibitor for the treatment of muscle-invasive bladder cancer (MIBC). The TAR-200 system continuously delivers the chemotherapy drug gemcitabine in the bladder for multiple weeks. The combination with Bristol-Myers Squibb’s Opdivo (nivolumab) will be […]
Valeritas touts study results
Valeritas (NSDQ:VLRX) today announced the results of a study that showed patients using its V-Go wearable insulin delivery device needed less insulin, had lower A1c levels and reduced diabetes-related medication cost compared with patients using multiple daily injection (MDI) therapy. The retrospective study by the Bridgewater, N.J.-based company used information from the HealthCore Integrated Research Database […]
Vectura seeks another $44M in GSK patent win
Fresh off its $89.7 million jury award in a patent infringement case against GlaxoSmithKline (NYSE:GSK), British inhaler company Vectura has petitioned the court for an additional $44 million. On May 16, a jury in U.S. District Court for the District of Delaware awarded Vectura damages for the period from August 2016 through December 2018 for […]
Taris Biomedical touts results of bladder cancer treatment study
Taris Biomedical today announced positive results from the second arm of a study of its TAR-200 system for the treatment of patients with muscle-invasive bladder cancer (MIBC). The most recent study arm involved 10 patients treated with TAR-200 and yielded positive safety, tolerability and preliminary efficacy data, according to Lexington, Mass.-based Taris. Combined data from […]
AbbVie to buy Allergan for $63 billion
Pharmaceutical giant AbbVie (NYSE:ABBV) said today it will acquire Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s blockbuster drug, Humira. AbbVie will pay Allergan shareholders $188.24 per share of Allergan stock, a 45% premium to yesterday’s closing price. Humira […]
Ocular Therapeutix gains second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has approved a supplemental NDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested in January that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery. Dextenza is designed to deliver drugs for up […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
