BTG (LON:BTG) touted data last week showing that patients with chronic deep vein thrombosis and post-thrombotic syndrome can be safely and effectively treated with the Ekos device and anti-coagulation drugs. The study’s protocol is the 1st treatment regimen proven to reduce the symptoms of PTS and demonstrate an improvement in quality of life for patients […]
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FDA clears IND for Cerveau’s tau imaging agent
Cerveau Technologies said today that the FDA cleared the investigational new drug application for its tau imaging agent. The company plans to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain. NFTs composed of aggregated tau protein are characteristic of certain neurodegenerative conditions like […]
Novartiz unit Sandoz seeks FDA nod for generic Advair Diskus
Novartis (NYSE:NVS) unit Sandoz said today that the FDA has accepted the abbreviated new drug application for its generic version of Advair Diskus. The fluticasone propionate/salmeterol device is designed to treat asthma in patients ages 4 and older, as well as provide maintenance treatment of airflow obstruction and reduce exacerbations in patients with chronic obstructive […]
Adamis up, Mylan down on generic EpiPen approval
Shares in Adamis Pharmaceuticals (NSDQ:ADMP) soared more than 50% yesterday after it won FDA approval for its generic EpiPen emergency allergy pre-filled syringe, sending shares in competitor Mylan (NSDQ:MYL) down -3%. For years, Mylan has commanded more than 90% of the market for emergency epinephrine injectors. Adamis’ device, called Symjepi, is intended to be a cheaper […]
Johnson & Johnson closes $30B Actelion buyout
Johnson & Johnson (NYSE:JNJ) closed its $30 billion buy of Swiss biotech firm Actelion, the company reported today. The US healthcare giant bought Actelion in an all-cash deal for $280 per share. The acquisition is expected to add $1.3 billion in sales for Johnson & Johnson in 2017, according to the company. “We are very […]
Tusker Medical raises $10m for pediatric tympanostomy device
Tusker Medical said yesterday that it raised more than $10 million for the pediatric ear surgery device it’s developing. The Menlo Park, Calif.-based company raised $10.2 million in an equity sale from a single unnamed investor, according to a regulatory filing. Tusker, formerly known as Advanced ENT Solutions, is developing a new technique for tympanostomies, in […]
Drug delivery devices: Here is West’s plan for success
West Pharmaceutical Services is betting that an embrace of human factors engineering and experiential design will allow its drug delivery devices such as its SmartDose and SelfDose to stand apart from the crowd. People are more likely to take their medications properly if a device is easy to use, Eric Resnick, vice president and chief […]
Blaze Bioscience touts Phase 1 data from pediatric oncology Tumor Paint BLZ-100 study
Oncology-focused biotech company Blaze Bioscience today released clinical data from the Phase 1 study of its Tumor Paint BLZ-100 in pediatric brain cancer patients, touting that the agent was well tolerated. Data from the study was presented at the 4th Biennial Pediatric Neuro-Oncology Basic and Translational Research Conference in New York. The BLZ-100 is the […]
BD recalls select Plastipak catheter tip syringes over leakage issues
Becton Dickinson (NYSE: BDX) is initiating a voluntary product recall for its 100ml Plastipak catheter tip syringes over leakage issues the company caught during testing. The Franklin Lakes, N.J. company discovered that the devices, which are labeled with a 5-year expiration date, were found to be failing during routine real-time stability tests, beginning at the […]
Sanofi, Parexel collaborate on clinical trial data collection wearables
Parexel said today it is collaborating with Sanofi (NYSE:SNY) to develop and promote wearable devices to improve collection of data during clinical trials. Through the collaborative deal, the 2 companies will leverage their specific expertise to explore how wearables could improve study performance and new drug development and how sensors from several wearable devices could be […]