U.S. Food and Drug Administration cleared the first seven tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magnetom Terra is the first 7T MRI system cleared for clinical use in the United States.
“The overall image quality of MRI improves with higher magnetic field strength,” stated Robert Ochs, Ph.D., director of the Division of Radiological Health in the FDA’s Center for Devices and Radiological Health. “The added field strength allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis.”
MRI is a medical imaging procedure that creates images of the internal structures of the body. MRI scanners use strong magnetic fields and radio waves (radiofrequency energy) to generate images. The signal comes mainly from the protons in fat and water molecules in the body. When interpreted by a trained physician, images from an MRI scan provide information that may be useful in determining a diagnosis. MRI scanners come in different magnet field strengths measured in tesla or “T.” Before today’s clearance, clinical MRI systems were available in field strengths of 3T and below.
The FDA reviewed the Magnetom Terra through the 510(k) premarket clearance pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
The FDA based its clearance on comparison to a predicate device and acquisition of sample clinical images. The agency reviewed the safety of the radiofrequency subsystem through computational modeling, simulations and rigorous experimental validation. The manufacturer also provided data from a comparative study of 35 healthy patients that compared images of the patients using the 7T device and images using the 3T device. Board-certified radiologists reviewed the images and confirmed that the images acquired on the 7T device were of diagnostic quality and, in some cases, an improvement over imaging at the 3T.
The Magnetom Terra is for patients who weigh more than 66 pounds, and is limited to examinations of the head, arms and legs (extremities).
The FDA granted clearance of Magnetom Terra system to Siemens Medical Solutions Inc.
Most of us probably know exercising is associated with a smaller risk of premature death, but a new study has found that doesn’t have to happen in a CrossFit box, a ninja warrior studio, or even a gym.
Body weight-bearing exercises such as sit-ups and push-ups staved off death just as much as other forms of weight-bearing exercise.
Our study recruited just over 80,000 adults over 30 years living in England and Scotland between 1994 and 2008, who were followed up for an average of nine years.
At the end of the followup period, we calculated their risk of death according to their strength-promoting exercise and how much they did.
What we found
Those who reported participation in any strength-promoting exercise (including gym workouts) averaged about 60 minutes a week and those who reported any own body weight exercises averaged 50 minutes a week.
Participation in either gym workouts or own body weight exercises reduced the risk of early death by about 20 percent. Cancer-related deaths also decreased by 24-27 percent, but there was little evidence more was better.
We also compared the risk of those who met the recommendation of two sessions of strength-promoting exercise per week, with those who met the recommendation of 150 minutes of aerobic physical activity such as walking (or 75 minutes more intense, such as running) per week.
Compared to being inactive, meeting either guideline was associated with a 16-18% reduction in risk of early death.
But the results on cancer death risk told us a very different story. Those who met only the strength-promoting guideline by doing body weight exercises had a 31 percent lower risk of death from cancer.
Those who met only the aerobic exercise guideline had no reduction in risk of cancer death.
On the other hand, reducing the risk of death from heart disease was only associated with aerobic physical activity (21 percent reduction).
Interpreting the results
Given this research is observational, there’s always a chance the relationship between exercise and early death could be due to other causes. Perhaps the people who exercised more were also just generally healthier in other ways.
To reduce the possibility of alternative explanations, we adjusted our results for age, sex, health status, obesity, other lifestyle behaviours (smoking, alcohol, diet), education level, mental health, and participation in other physical activity such as domestic activities, walking and aerobic exercise.
People with chronic diseases are less likely to exercise, and more likely to die early. Therefore we excluded from the results all participants who had heart disease or cancer, as well as those who died in the first two years of the followup (because their death was most likely caused by something they had prior to the study commencing).
Other studies have examined the relationship between strength promoting exercise and early death. An American study found lifting weights or doing callisthenics was associated with a 31 percent decrease in risk of death from any cause, which is consistent with our results.
But contrary to our results, the same study found no association with cancer death risk.
Another study among cancer survivors showed lifting weights, but not aerobic activities, was associated with a 33 percent lower risk of death from any cause.
What it all means
Our study suggests exercise that promotes muscular strength has unique health benefits and is at least as important for health as walking, cycling, and other aerobic activities.
We shouldn’t forget the most important principle for choosing an activity is being able to incorporate it into your routine and stick to it long term. The simplicity of body weight exercises makes them a very attractive option: they are inexpensive and require little skill and no equipment.
Plus we now know they yield comparable benefits to similar gym-based activities. This is important given gyms can be daunting or unaffordable for many people.
So in addition to doing enough moderate to vigorous intensity aerobic activity, good old fashioned push-ups or chin-ups at home, in the park, in the yard, or even in the office could be an excellent option.
For most people two to three sessions a week would be sufficient for general health.
The American College of Sports Medicine recommends 2-4 sets of 8-15 repetitions of each strength promoting exercise with 2-3 minutes rest between sets.
As with any physical activity, the most important principle here is a little is better than nothing, and gradually build up from little to enough.
The U.S. Food and Drug Administration granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.”
Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma and, according to the National Cancer Institute at the National Institutes of Health, represents 3 to 10 percent of all non-Hodgkin lymphoma cases in the U.S. Mantle cell lymphoma is a cancer of the lymph system, which is part of the body’s immune system and is made up of lymph tissue, lymph nodes, the spleen, thymus, tonsils and bone marrow. By the time mantle cell lymphoma is diagnosed, it usually has spread to the lymph nodes, bone marrow and other organs.
Calquence is a kinase inhibitor that works by blocking an enzyme needed by the cancer to multiply and spread.
Calquence was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is unmet medical need and a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients. Further study is required to verify and describe anticipated clinical benefits of Calquence and the sponsor is currently conducting this trial.
Today’s approval of Calquence was based on data from a single-arm trial that included 124 patients with mantle cell lymphoma who had received at least one prior treatment. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate). In the trial, 81 percent of patients had a complete or partial response (40 percent complete response, 41 percent partial response).
Common side effects of Calquence include headache; diarrhea; bruising; fatigue and muscle pain (myalgia); and reduced levels of red blood cells (anemia), platelets (thrombocytopenia) and neutrophils (neutropenia) in the blood.
Serious side effects include bleeding (hemorrhage), infections and irregular heartbeat (atrial fibrillation). Additional cancers, known as second primary malignancies, have occurred in some patients taking Calquence. Women who are breastfeeding should not take Calquence because it may cause harm to a newborn baby.
The FDA granted this application Priority Review and Breakthrough Therapy designations. Calquence also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
The FDA granted the accelerated approval of Calquence to AstraZeneca Pharmaceuticals LP.
The U.S. Food and Drug Administration today announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry with research spanning domestic and international clinical sites.
“We are proud of our 30-year track record of fostering and encouraging the development of safe and effective therapies for rare diseases through our clinical trials grant program,” said Gayatri R. Rao, M.D., J.D., director of FDA’s Office of Orphan Product Development, within the Office of Special Medical Programs. “The grants awarded this year will support much-needed research in 21 different rare diseases, many of which have little, or no, available treatment options.”
The FDA awards the grants through the Orphan Products Clinical Trials Grants Program to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases. The grants are intended for clinical studies evaluating the safety and effectiveness of products that could either result in, or substantially contribute to, the FDA approval of products.
Since its creation in 1983, the Orphan Products Clinical Trials Grants Program has provided more than $370 million to fund more than 590 new clinical studies and supported the marketing approval of more than 55 products. Five of the studies funded by this grants program supported product approvals in 2015 alone, including much needed treatments for neuroblastoma, lymphangioleiomyomatosis, hypoparathyroidism, and hypophosphatasia.
Consistent with the tenor set by Vice President Joe Biden’s National Cancer Moonshot Initiative to accelerate cancer research, 24 percent of the new grant awards fund studies enrolling patients with cancer; 40 percent of these studies target devastating forms of brain cancer, one of which recruits children with recurrent or progressive malignant brain tumors.
Forty-three percent of this year’s awards fund studies that enroll pediatric patients as young as newborns. Of these, two focus on research in transplantation and related issues.
In addition, one funded project is a medical device trial to develop a fully implantable neuroprosthesis for grasp, reach, and trunk function in individuals with spinal cord injury with the potential to enable these patients to use their hand, arm, and trunk more independently.
A total of 68 grant applications were received for this fiscal year, with a funding rate of 31 percent (21/68). The grant recipients for fiscal year 2016 include:
- Chemigen, LLC (Zionsville, Indiana), Yansheng Du, Phase 1 Study of CC100 for the Treatment of Amyotrophic Lateral Sclerosis — about $243,000 for one year
- Chemocentryx, Inc. (Mountain View, California), Petrus Bekker, Phase 2 Study of CCX168 for the Treatment of Anti-Neutrophil Cytoplasmic Auto-Antibodies Associated Vasculitis — $500,000 for one year
- Columbia University Health Sciences (New York, New York), Elizabeth Shane, Phase 2B Study of Denosumab to Prevent Bone Loss in Idiopathic Osteoporosis in Premenopausal Women Treated with Terripatide — about $1.6 million over four years
- DNATRIX, Inc. (Houston, Texas), Frank Tufaro, Phase 2 Study of DNX-2401 for the Treatment of Glioblastoma — $2 million over four years
- Elorac, Inc. (Vernon Hills, Illinois), Scott Phillips, Phase 3 Study of Naloxone Lotion for the Treatment of Pruritus in Mycosis Fungoides — about $2 million over four years
- Johns Hopkins University (Baltimore, Maryland), Pamela Zeitlin, Phase 1/2 Study of Glycerol Phenylbutyrate for the Treatment of Cystic Fibrosis — $750,000 over three years
- Oncoceutics, Inc. (Hummelstown, Pennsylvania), Wolfgang Oster, Phase 1/2 Study of ONC201 for the Treatment of Multiple Myeloma — about $1.7 million over four years
- Oregon Health and Science University (Portland, Oregon), Kevin Winthrop, Phase 2 Study of Clofazimine for the Treatment of Pulmonary Mycobacterium Avium Disease — about $1.8 million over four years
- Santhera Pharmaceuticals (Liestal, Switzerland), Thomas Meier, Phase 1 Study of Omigapil for the Treatment of Congenital Muscular Dystrophy — $246,000 for one year
- Scioderm, Inc. (Durham, North Carolina), Jay Barth, Phase 3 Study of SD101 for the Treatment of Epidermolysis Bullosa — $500,000 for one year
- Seattle Children’s Research Institute (Seattle, Washington), Leslie Kean, Phase 2 Study of Abatacept Combined with Calcineurin Inhibition and Methotrexate for Prophylaxis of Graft Vs Host Disease — $99,630 for one year
- Sloan-Kettering Institute Cancer Research (New York, New York), Katharine Hsu, Phase 1 Study of Humanized 3F8 MoAb and NK cells for the Treatment of Neuroblastoma — about $750,000 over three years
- Taimed Biologics USA Corp (Irvine, California), Stanley Lewis, Phase 3 Study of Ibalizumab for the Treatment of Patients with Multidrug Resistant HIV — $500,000 for one year
- University of Alabama (Birmingham, Alabama), Gregory Friedman, Phase 1 Study of HSV G207 & Radiation for the Treatment of Pediatric Brain Tumors — about $750,000 over three years
- University of California, San Diego (La Jolla, California), Donald Durden, Phase 1 Study of PI-3 Kinase/BRD4 Inhibitor SF1126 for the Treatment of Hepatocellular Carcinoma — $750,000 over three years
- University of Florida (Gainesville, Florida), Peter Stacpoole, Phase 3 Study of Dichloroacetate for the Treatment of Pyruvate Dehyrugenase Complex Deficiency — about $2 million over four years
- University of Michigan (Ann Arbor, Michigan), Kathleen Stringer, Phase 2 Study of Inhaled Activase for the Treatment of Acute Plastic Bronchitis — $2 million over four years
- University of North Carolina Chapel Hill (Chapel Hill, North Carolina), Matthew Laughon, Phase 2 Study of Furosemide for the Prevention of Bronchopulmonary Dysplasia in Premature Infants — about $1.4 million over four years
- Vanderbilt University Medical Center (Nashville, Tennessee), Cyndya Shibao, Phase 2 Study of Atomoxetine for the Treatment of Multiple System Atrophy — about $1.6 million over four years
- Wilson Wolf Manufacturing Corporation (New Brighton, Minnesota), Sunitha Kakarla, Phase 1 Study of Viralym-A for the Treatment of Adenovirus Disease — about $750,000 over three years
- Case Western Reserve University (Cleveland, Ohio), Kevin Kilgore, Phase 2 Study of a Networked Neuroprosthesis for Grasp, Reach, and Trunk Function in Cervical Spinal Cord Injury — about $2 million over four years
The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.
“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” said Jean-Marc Guettier, M.D., C.M., director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research. “Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”
According to the Centers for Disease Control and Prevention, death from cardiovascular disease is 70 percent higher in adults with diabetes compared to those without diabetes, and patients with diabetes have a decreased life expectancy driven in large part by premature cardiovascular death.
The FDA’s decision is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Jardiance was studied in a postmarket clinical trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease. In the trial, Jardiance was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.
Jardiance can cause dehydration and low blood pressure (hypotension). Jardiance can also cause increased ketones in the blood (ketoacidosis), serious urinary tract infection, acute kidney injury and impairment in renal function, low blood glucose (hypoglycemia) when used with insulin or insulin secretagogues (e.g. sulfonylurea, a medication used to treat type 2 diabetes by increasing the release of insulin in the pancreas), vaginal yeast infections and yeast infections of the penis (genital mycotic infections), and increased cholesterol.
The most common side effects of Jardiance are urinary tract infections and female genital infections.
Jardiance is not intended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Jardiance is contraindicated in patients with a history of serious hypersensitivity reactions to Jardiance, severe renal impairment, end-stage renal disease, or dialysis.
Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.