Doctors in Pennsylvania reported this week that combining immunotherapy drugs with radiotherapy could help to more efficiently treat malignant pleural mesothelioma. The analysis from the University of Pennsylvania looked at studies that combined immunotherapy drugs like Merck‘s (NYSE:MRK) Keytruda with radiation therapy. The team concluded that radiotherapy may boost the cancer-killing effects of immunotherapies. Get the […]
Drug-Device Combinations
FDA chief: Changing generics regulations could reel in drug prices
Part of the FDA commissioner’s job is to oversee the federal regulatory watchdog as it evaluates pharmaceuticals for safety and efficacy. Most FDA chiefs have avoided the topic of drug prices, given that it isn’t a clearly-stated part of the agency’s mission But just 2 weeks into the job, newly-confirmed FDA commish Dr. Scott Gottlieb proposed […]
Artificial pancreas: These companies are racing to make one
Medical device companies are close to achieving the holy grail of diabetes treatment: a combined glucose sensor, control algorithm and insulin infusion device that effectively acts as an “artificial pancreas.” We explain more in the newest video from editors at MassDevice’s sister publication Medical Design & Outsourcing. (And for a deeper dive, check out our recent […]
Ultrasound-drug combo treats pulmonary embolism in less time with fewer drugs
When venous clots break off and travel through a patient’s circulatory system, they can become trapped in the lung and block blood flow. This strains the heart’s ability to pump blood through the lungs and can ultimately lead to heart failure. Traditionally, patients with pulmonary embolisms are treated overnight with systemic infusions of tissue plasminogen […]
BioCorRx to meet with the FDA for injectable, sustained-release opioid addiction therapy
BioCorRx (OTC:BICX) said today that the FDA has granted the anti-addiction developer a pre-investigational new drug meeting, scheduled for Sept. 19. The Anaheim, Calif.-based company said it is slated to review the development and marketing plan for BICX101, an injectable, sustained-release formulation of naltrexone as a therapy for opioid addiction and alcohol use disorders. Get […]
Medtronic launches study of In.Pact Admiral drug-coated balloon in end-stage renal disease
Medtronic (NYSE:MDT) said today that the 1st patient was enrolled in a study of its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The FDA approved the investigational device exemption study to evaluate the device as a treatment for failing arteriovenous fistulas in end-stage renal disease patients. Get the full story at our sister […]
ATS Roundup: Emulate models viral infection in “asthma-on-a-chip”
Emulate‘s small airway-lung chip could help researchers study viral-induced exacerbations of asthma, according to data presented this week at the American Thoracic Society’s annual meeting. The studies were conducted as part of the company’s partnership with (NYSE:MRK). The collaborative project was designed to enable development of new anti-inflammatory treatments for patients with asthma, according to Emulate. […]
Valeritas touts cost savings, real-world outcomes with V-Go insulin pump
In a retrospective analysis of 86 diabetic patients who switched from multiple daily insulin injections to the V-Go insulin pump, Valeritas (NSDQ:VLRX) reported this week that use of its device led to a 44% reduction in total daily insulin dose per patient. A drastic cut to a patient’s daily insulin dose and improvement to their blood sugar levels […]
Anika onshores manufacturing capabilities with new Bedford facility
Anika Therapeutics (NSDQ:ANIK) opened a new global manufacturing facility today, on the same day that it celebrated the 25th anniversary of its Bedford, Mass.-based headquarters. Anika’s manufacturing operations were previously split between its U.S. headquarters and an Italy-based contract manufacturer. But in a move to onshore manufacturing to the U.S., the company said it hopes […]
UK watchdog accuses Merck of restricting biosimilar competition
Britain’s Competition and Markets Authority accused Merck‘s (NYSE:MRK) European unit, Merck Sharp & Dohme, of conducting an unfair discount scheme that it said was designed to restrict competition from biosimilar copies of the company’s drug, Remicade. Remicade is an antibody drug used to treat rheumatoid arthritis, ulcerative colitis and Chron’s disease. It was the 1st […]
Novartis’ Ultibro Breezhaler tops corticosteroid for COPD in head-to-head study
Novartis (NYSE:NVS) said today that a new analysis of its head-to-head Flame trial showed that inhaled corticosteroids may not be necessary in some chronic obstructive pulmonary disease patients with high blood eosiophil counts. The data demonstrated that the company’s Ultibro Breezhaler provided better or similar benefits compared to Seretide, an inhaled corticosteroid, in COPD patients […]