On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. “Over the past decade, we’ve […]
Clinical Trials
NIH kicks off study of combo antibody HIV therapy
The National Institutes of Health reported this week that it launched a clinical trial evaluating a combination of antibodies in people with HIV. The early-stage study is designed to assess whether periodic infusions of two HIV-specific antibodies are safe in people living with HIV. Researchers also plan to gather preliminary data assessing how effectively the […]
Clovis forks over $20m to settle SEC charges that it misled investors
The SEC said today that Clovis Oncology (NSDQ:CLVS), its CEO and former CFO will pay more than $20 million to settle charges that the company misled investors about its experimental lung cancer drug. The SEC alleged that beginning in July 2015 and over the course of a four-month period, CEO Patrick Mahaffy and his team […]
AstraZeneca touts long-term safety, efficacy data for asthma biologic
AstraZeneca (NYSE:AZN) today touted results from a Phase III extension trial evaluating the long-term safety and efficacy of benralizumab as an add-on maintenance therapy for patients with severe eosinophilic asthma. Benralizumab, or Fasenra, is approved as an add-on maintenance treatment for severe eosinophilic asthma in an array of countries, including the U.S., the E.U., and Japan. […]
Researchers launch early-stage trial for nasal flu vaccine
Researchers at St. Louis University reported that an early-stage trial testing an experimental nasal flu vaccine in children and teens began enrolling participants this week. In the 50-person study, half of the participants will receive the investigational nasal vaccine and the other half will receive an inactive saline solution. All of the study’s participants are […]
NIH study finds daily aspirin does not prolong healthy lifespan
In a 19,114-person trial supported by the National Institutes of Health, researchers found that daily low-dose aspirin did not prolong independent living in healthy older adults. Initial findings from the Aspree trial, which began in 2010, were published in The New England Journal of Medicine this week. The study involved participants who did not have […]
PCI Pharma Services to buy Sherpa Clinical Packaging
PCI Pharma Services has agreed to acquire clinical supply services provider Sherpa Clinical Packaging, the companies announced today. Financial terms of the deal were not disclosed. San Diego–based Sherpa is a provider of clinical trial material management services for clinical studies phases I through IV, with expertise in packaging, labeling, distribution, storage and returns and […]
Medtronic launches one-month DAPT study for drug-eluting stent in U.S., Japan
Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention. The company’s Onyx One Clear study is one of the first designed to assess the risk of cardiac death and stent […]
Boston Scientific launches trial for drug-eluting peripheral stent
Boston Scientific (NYSE:BSX) said last week that it enrolled the first patient in a pivotal trial to evaluate its below-the-knee drug-eluting stent in patients with critical limb ischemia. The peripheral stent is the first of its kind to undergo the FDA’s breakthrough device program, according to the medtech giant. Roughly 17 million people in the U.S. […]
Novocure touts combined TTF, chemotherapy mesothelioma study data
Novocure (NSDQ:NVCR) today released results from the Stellar phase 2 registration trial exploring the use of its Tumor Treating Fields and standard of care chemotherapy to chemotherapy alone in treating mesothelioma, touting a significant extension in median overall survival. Patients with malignant pleural mesothelioma who received TTF treatment alongside pemetrexed and cisplatin or carboplatin experienced a […]