The Senate Committee on Health, Education, Labor and Pensions is scheduled to vote today on several health care-related bills, including the Opioid Crisis Response Act, a bipartisan bill that includes measures to restrict the number of painkillers physicians can prescribe, direct research toward finding nonaddictive painkillers and prevent illegal drug trafficking. Another bill up for consideration is the Over-the-Counter Drug Safety, Innovation, and Reform Act, which would revise how over-the-counter medications are regulated and allow the FDA to collect user fees on them.
Integrating data into the care process holds a great deal of promise for the health care industry. But medical device industry leaders agree that there are system complexities that need to be solved -- with lack of good data a critical issue. That was a major takeaway from a Healthcare Technology Leadership Panel at the 6th Annual World Patient Safety, Science & Technology Summit, held earlier this year in London. Panelists included a who's who of medical device industry leadership: Matt Darling, co-founder of SmartWard; Frans van Houten, CEO, Royal Philips; Anders Wold, president and CEO, GE Healthcare Clinical Care Solutions; and Dr. Charles Murphy, chief patient safety officer, Inova Heart and Vascular Institute, Falls Church, Va. Medtronic CEO Omar Ishrak moderated the panel. Read the story.
Former Vice President Joe Biden asked 300 donors, trustees, scientists and dignitaries gathered at the Salk Institute for Biological Studies to help foster collaboration and cooperation in the cancer research sphere. Biden says he can "see the day" when cancer prevention and treatment are more effective, when vaccines against cancer are commonplace, and when patients get the right therapy on the first try.
Abeona Therapeutics' ABO-102, which is being developed as a treatment for patients with Sanfilippo syndrome type A, was granted regenerative medicine advance therapy designation by the FDA. The drug candidate is in a Phase I/II clinical trial.
The FDA granted breakthrough therapy status to Pfizer's Trumenba, which is being developed for children ages 1 to 9 to prevent invasive disease caused by Neisseria meningitidis group B. The drug was already approved for patients ages 10 to 25.
Pfizer's Mylotarg, or gemtuzumab ozogamicin, was approved in combination with chemotherapy agents daunorubicin and cytarabine by the European Commission as a treatment for patients at least 15 years old who have previously untreated de novo CD33-positive acute myeloid leukemia.
Ziegenfelder closed its Denver production facility and recalled about 3,000 cases of Budget $aver brand fruit-flavored ice pops produced at the plant after state inspectors found Listeria monocytogenes in the facility. The recalled products are Cherry Pineapple Monster Pops and Sugar Free Twin Pops with the UPC codes 0-74534-84200-9 and 0-74534-75642-9, respectively, which were shipped in 15 states.
A clinical trial collaboration agreement in the US, Canada and Europe between Medtronic and Arca Biopharma was extended until April 2019. Under the deal, Medtronic will continue to support trial use of its monitoring devices, manage cardiac rhythm analysis with its devices and collect data on managed atrial fibrillation burden.
Surmodics obtained 510(k) clearance from the FDA for its 0.018-inch Low-Profile percutaneous transluminal angioplasty balloon dilation catheter, which is intended for 2- to 10-mm-diameter peripheral vascular applications. The device is a combination of balloon technologies and the company's proprietary low-friction, low-particulate hydrophilic coating called Serene.
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