FDA Commissioner Scott Gottlieb said the agency is taking steps to prevent the potential misuse and abuse of gabapentinoids, which could result in serious adverse events. The agency was alarmed by reports of off-label prescribing of gabapentinoids to treat pain, and as an alternative to opioids.
University of California, San Diego, engineers have created a smartphone case that, when paired with an app, can make it easier for people with diabetes to track and record blood glucose levels on the go. "Integrating blood glucose sensing into a smartphone would eliminate the need for patients to carry a separate device," said Patrick Mercier, professor of electrical and computer engineering at UC San Diego. "An added benefit is the ability to autonomously store, process and send blood glucose readings from the phone to a care provider or cloud service," he said. GlucPhone is a portable glucose-sensing system created by Mercier and nanoengineering professor Joseph Wang. The device has two parts: The first is a slim, 3D-printed case with a permanent, reusable sensor in the corner. The second part contains small, one-time-use, enzyme-packed pellets and attaches to the sensor with a magnet. The pellets are encased in a 3D-printed stylus attached to the side of the case.
Dai Nippon Printing and a team of University of Tokyo researchers developed an integrated biomedical sensor system, called "skin electronics," which allows the moving electrocardiogram waveform recorded by a lightweight sensor to be shown on a wearable elastic skin display. The sensor system, which Dai Nippon Printing expects to market within the next three years, comes with a wireless communication module, enabling the transmission of biometric data to the cloud for storage or a smartphone for viewing.
Janssen reported at the 2018 American Academy of Dermatology that patients with moderate to severe plaque psoriasis who were treated with Tremfya, or guselkumab, achieved 90% improvement in their condition at week 28 and maintained that through to week 72 if treatment was continued. Results were from the VOYAGE 2 study, which also demonstrated that 87.6% of the 173 patients who stopped receiving the drug achieved a Psoriasis Area and Severity Index 90 response within six months of restarting retreatment.
BerGenBio completed the 28-patient enrollment into the first of two stages of a Phase II study of its bemcentinib in combination with Merck's Keytruda, or pembrolizumab. The trial will assess the safety and efficacy of the combo drug as a potential treatment for patients with previously treated, locally advanced and unresectable or metastatic triple-negative breast cancer or triple-negative inflammatory breast cancer.
UCB's Vimpat, or lacosamide, was approved by the Scottish Medicines Consortium for National Health Service use as an adjunctive treatment for patients 4 years of age and older with partial-onset seizures with or without secondary generalization. The drug was previously approved in adult and adolescent patients.
A bill that would establish a state drug importation program, which will allow drug imports from Canada at lower prices, was approved by Utah's House of Representatives. The bill, which now advances to the state Senate for consideration, seeks HHS approval for Utah to allow contracted wholesale pharmacies to buy prescription drugs from approved wholesalers in Canada.
A recall was issued by Pilgrim's Pride for about 101,310 pounds of ready-to-eat chicken patties from schools and other institutions nationwide after a consumer found rubber in the product. The recalled products were Gold Kist Farms, Fully Cooked Whole Grain Home-Style Breaded Chicken Patties packed in 30-pound boxes with the establishment number P-20728.
More than 300 standards will be revised by the China Food and Drug Administration under a two-year plan to align the country's medical devices and in vitro diagnostics with international standards and as part of existing reforms that include better quality system management and oversight and more stringent device standards. The agency intends to promote innovation and determine priority areas for the development of devices to resolve unmet needs.
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