Mayo Clinic researchers say molecular breast imaging, combined with mammograms, yields a nearly fourfold higher likelihood of detecting breast cancer in women with dense breasts, compared with mammography alone. A study in a radiology journal involving 1,696 women with dense breasts showed that MBI detected 13 cancer malignancies that weren't discovered by mammograms.
Sound waves may help even out brain activity to ease migraine symptoms and lower blood pressure, according to data scheduled to be presented at the American Heart Association's Council on Hypertension 2016 Scientific Sessions. High-resolution, relational, resonance-based, electroencephalic mirroring, or HIRREM, senses imbalances in the brain via sensors placed on patients' scalps and sends the information to a computer, which then creates tones that are played back to the patient.
Patients with gastrointestinal or colorectal cancer who get highly or moderately emetogenic chemotherapy may have less nausea and vomiting if they are given rolapitant with a 5-HT3 receptor antagonist and dexamethasone, according to study data presented at the 2016 Palliative Care in Oncology Symposium. Researchers said patients given rolapitant had higher rates of complete response compared with those taking a placebo.
The modified dosage regimen for Bristol-Myers Squibb's Opdivo, or nivolumab, has been approved by the FDA for the treatment of advanced renal cell carcinoma, unresectable or metastatic melanoma and metastatic non-small cell lung cancer. The drug is now recommended as a 240-mg intravenous, flat-dosing regimen every two weeks until intolerable toxicity or disease progression.
India-based Glenmark Pharmaceuticals will work with US-based Particle Sciences to create a generic of breast- and lung-cancer drug Abraxane, by Celgene. Particle expects to file an abbreviated new drug application in fiscal year 2019.
A study in the Annals of Internal Medicine showed hospital employment of physicians increased from 29% in 2003 to 42% in 2012, but researchers did not find an association between the switch to an employment model and improvements in quality metrics, such as mortality and readmissions. The study found large hospitals, teaching facilities and nonprofits were more likely to move to physician employment.
Allowing Medicare to negotiate prices directly with drugmakers would do little to reduce overall drug costs, and capping patients' out-of-pocket drug costs would probably lead to higher insurance premiums, according to this Kaiser Health News analysis.
A final rule has been issued by HHS requiring companies to post results of interventional studies involving FDA-approved and unapproved devices, drugs and biological products in the ClinicalTrials.gov database effective Jan. 18, 2017. The rule, which has been extended by a final NIH policy to all trials funded by the institute regardless of phase, is not applicable to small feasibility studies of devices, Phase I trials of biological products and drugs, and data for investigational products under expanded access protocols.
Expanded data sharing and collaboration would help the Alzheimer's disease research community learn from previous failures and allow new drug targets to be developed and validated, says Enrica Alteri, head of human medicines research and development support at the European Medicines Agency. She said the EMA and FDA are working together on guidelines and standards to streamline Alzheimer's disease drug development.
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