FDA’s Gottlieb updates on Puerto Rico and medical product shortages

FDA commissioner Dr. Scott Gottlieb provided an update today to the work that the agency is doing to help medical device manufacturers in Puerto Rico in the weeks following Hurricanes Irma and Maria. The FDA chief noted that even though some major medical product manufacturers have regained power, many firms continue to run on generator

Manufacturing drug device products: challenges and best practices

Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable. There’s a lot to consider when manufacturing a medical

How a built-in refrigerator ice dispenser can dispense medication

An Arizona State University student recently designed an automatic medicine dispenser that could replace water and ice dispensers on refrigerators, according to a case study from Model Solution (Milpitas, Calif.). The device can dispense pills for two different users and gives audio and visual signals for the times that the users have to take their

FDA approves first ALS treatment in over 2 decades

The FDA recently announced that it has approved the drug Radicava (edaravone) to help treat patients who have amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. ALS is a progressive neurodegenerative disease that affects the nerve cells in the brain and spinal cord, according to the ALS Association. Motor neurons in the brain

3D protein structure algorithm could transform drug therapy development

A group of University of Toronto researchers has developed a machine learning algorithm that creates 3D structures of protein molecules that may help transform drug therapy developments. Knowing the 3D shape of the protein is important for trying to understand how they work and respond to drug therapies. “Designing successful drugs is like solving a

Foster Delivery Science and ProMed Pharma partner for drug delivery applications

Foster Delivery Science and ProMed Pharma have partnered commercially for comprehensive contract services for pharmaceutical and combination device applications. The companies plan to offer thermoplastic and silicone formulation development through the production of drug delivery components. Foster Delivery Science offers blending and extrusion of melt processable polymers and active pharmaceutical ingredients like water soluble, bioresorbable

Beyond UDIs: The drug industry has something to teach medtech about value-based care

Unique device identifiers are about to revolutionize the medical device market. But with nearly 40 years of experience in collecting information on pharmaceuticals for healthcare providers, pharmacies, and payers, First Databank (FDB) officials know that UDIs alone won’t be enough. Medtech needs to think beyond UDIs and connect them with electronic health records (EHRs) and healthcare

Potential Trump pick for FDA chief lacks medical experience, prompting concerns

President-elect Donald Trump is reportedly considering Jim O’Neill, a libertarian and Silicon Valley investor with no medical experience, as head of the FDA and that has some healthcare experts concerned. O’Neill has made controversial statements about the federal safety watchdog, including in 2014 when he said that the agency should no longer evaluate whether medical devices or

Usnic acid electrospun fibers demonstrate antibacterial properties

Researchers from the Institute of Materials Science in Juazeiro, Brazil have reported on the antibacterial properties of usnic acid, a strong lichen metabolite, encapsulated in electrospun fibers. The team’s work was published in Recent Patents on Nanotechnology. Usnic acid has been used in commercial products, such as creams, toothpastes and sunscreen, due to their antiviral, animicrobial

Breast cancer drug discovery offers hope of new treatments

A drug for breast cancer that is more effective than existing medicines may be a step closer thanks to new research. Scientists have identified a chemical compound that is highly effective at blocking the growth of breast cancer cells in the laboratory. The compound—called eCF506—targets a molecule called “Src tyrosine kinase” that is required for breast

Heating chemotherapy drugs may improve bladder cancer treatment

Scientists have found that heating the chemotherapy drug mitomycin-C prior to using it for treating bladder cancer may radically improve its efficacy. The findings, published in the International Journal of Hyperthermia, are the result of a four-and-a-half-year study by medics based at Comarcal Hospital, Monforte, Spain. The ‘Recirculant hyperthermic IntraVEsical chemotherapy (HIVECä)’ treatment devised by