Breaking News
August 15, 2018 - Early Onset Type 1 Diabetes Linked to Heart Disease, Shorter Life
August 14, 2018 - SMURF1 provides targeted approach to preventing cocaine addiction relapse
August 14, 2018 - Genetic testing pushed for hereditary high cholesterol disease
August 14, 2018 - Researchers discover new genes involved in Alzheimer’s Disease
August 14, 2018 - Medicare to overhaul ACOs but critics fear fewer participants
August 14, 2018 - Adolescent health projects receive meager percentage of global funding, study finds
August 14, 2018 - University Hospitals Seidman Cancer Center launches new CAR-T therapy trial
August 14, 2018 - In the addiction battle, is forced rehab the solution?
August 14, 2018 - Busting myths about milk – Scope
August 14, 2018 - Platelet-rich plasma does not enhance cartilage formation capabilities of stem cells
August 14, 2018 - Wearable devices and ‘mhealth’ technology emerge as promising tools for better health
August 14, 2018 - Phase 2 Clinical Data Published Showing Summit’s Ridinilazole Preserved Gut Microbiome of Patients with CDI
August 14, 2018 - Cardiac progenitor cells undergo a cell fate switch to build coronary arteries
August 14, 2018 - Study identifies potential guidance to treat gastric cancer patients
August 14, 2018 - Revealed: The molecular mechanism underlying hypertrophic cardiomyopathy, or “workaholic heart”
August 14, 2018 - Diabetes epidemic in Guatemala driven by aging, not obesity
August 14, 2018 - New technology shows potential to streamline the analysis of proteins
August 14, 2018 - Rethinking the stroke rule ‘time is brain’
August 14, 2018 - Incidence of coronary artery compression in children may be more common than previously thought
August 14, 2018 - Study helps to better understand disease caused by Alpha-1 antitrypsin deficiency
August 14, 2018 - AI platform identifies acute neurological illnesses faster than human diagnosis
August 14, 2018 - American College of Rheumatology receives grants to support development of lupus clinical trials
August 14, 2018 - New study explains why women get more migraines than men
August 14, 2018 - American Heart Association Urges Screen Time Limits for Youth
August 14, 2018 - Brief interventions during routine care reduce alcohol use among men with HIV
August 14, 2018 - New genome analysis could identify people at higher risk of common deadly diseases
August 14, 2018 - NIH grant for Mount Sinai to study use of inhaled corticosteroids for treatment of sickle cell disease
August 14, 2018 - Daicel supplies free nanodiamond samples to international researchers
August 14, 2018 - Switching anti-psychotic drugs in first-episode schizophrenia patients does not improve clinical outcomes
August 14, 2018 - Study to examine whether modulating gut bacteria can improve cardiac function in heart failure patients
August 14, 2018 - AI technology could hold key to improving health services
August 14, 2018 - One out of two children not getting enough nutrients needed for their health
August 14, 2018 - Mono-antiplatelet therapy after aortic heart valve replacements may work as well as two drugs
August 14, 2018 - Aid-in-dying patient chooses his last day
August 14, 2018 - Exercise Really Can Chase Away the Blues, to a Point
August 14, 2018 - Surgical mesh implants may cause autoimmune disorders
August 14, 2018 - Researchers develop revolutionary zebrafish model to gain more insight into bone diseases
August 14, 2018 - Researchers discover secret communication hotline between breast cancers and normal cells
August 14, 2018 - Study examines how a person adapts to visual field loss after stroke
August 14, 2018 - Researchers show how specialized nucleic acid-based nanostructures could help target cancer cells
August 14, 2018 - Reducing opioid prescriptions for one operation can also spill over to other procedures
August 14, 2018 - E-cigarettes not so safe but still better than cigarettes
August 14, 2018 - Researchers find link between common ‘harmless’ virus and cardiovascular damage
August 14, 2018 - Initiation of PIMs associated with higher risk of fracture-specific hospitalizations and mortality
August 14, 2018 - Genetically modified mosquitoes and special bed nets help tackle deadly diseases
August 14, 2018 - Advances in treating hep C lead to new option for transplant patients
August 14, 2018 - Study finds quality of doctor-patient discussions about lung cancer screening to be ‘poor’
August 14, 2018 - MSU researchers uncover the effects of aging on regenerative ability of kidneys
August 14, 2018 - Better conditioning, throwing mechanics can help reduce elbow injuries in young baseball pitchers
August 14, 2018 - Brain game doesn’t offer brain gain
August 14, 2018 - Reproductive choices facing women with disabilities require careful consideration
August 14, 2018 - Scientists pinpoint the cause of a rare childhood seizure disorder
August 14, 2018 - Lumpectomy plus radiation associated with reduced risk of breast cancer death, study finds
August 14, 2018 - UAB study shows how ion channel differentiates newborn and mature neurons in the brain
August 14, 2018 - Experts highlight key knowledge gaps that need to be addressed in Ebola vaccine research
August 14, 2018 - Discovery could lead to new drugs against infection and inflammation
August 14, 2018 - Infection Prevention Differs Between Small, Large Hospitals
August 14, 2018 - Mom still matters—In study, young adults tended to prioritize parents over friends
August 14, 2018 - Deep brain stimulation might benefit those with severe alcoholism, preliminary studies show
August 14, 2018 - Study finds increased rate of repeat pregnancies in women with intellectual and developmental disabilities
August 14, 2018 - Lighter sedation fails to reduce risk of postoperative delirium in older patients
August 13, 2018 - Asking better questions about person’s memory could improve doctors’ understanding of patients
August 13, 2018 - U.S. Trauma Doctors Push for Stricter Gun Controls
August 13, 2018 - Asthma and flu: a double whammy
August 13, 2018 - 5 Questions: Donna Zulman on engaging high-need patients in intensive outpatient programs | News Center
August 13, 2018 - Behavioral Nudges Lead to Drop in Prescriptions of Potent Antipsychotic
August 13, 2018 - Potential New Class of Drugs May Reduce Cardiovascular Risk by Targeting Gut Microbes
August 13, 2018 - How to get your kids to eat better
August 13, 2018 - The importance of hearing your patients
August 13, 2018 - Transmission of F. tularensis unlikely to happen through the food chain
August 13, 2018 - Researchers discover epigenetic mechanism underlying ischemic cardiomyopathy
August 13, 2018 - Adolescent health programs receive only a tiny share of international aid, finds research
August 13, 2018 - Fracture risk increases by 30% after gastric bypass, study shows
August 13, 2018 - Quality-improvement project to standardize feeding practices helps micro preemies gain weight
August 13, 2018 - Long-term cannabinoid exposure impairs memory, study shows
August 13, 2018 - New intervention to reduce risk of HIV in young transgender women
August 13, 2018 - Japan human trial tests iPS cell treatment for Parkinson’s
August 13, 2018 - Altered nitrogen metabolism may contribute to emergence of new cancer mutations
August 13, 2018 - Cycling provides greatest health benefits, study finds
August 13, 2018 - Scientists discover biomarker for kidney cancer
D.C. Week: FDA Okays Single-Pill Tx for HIV

D.C. Week: FDA Okays Single-Pill Tx for HIV

image_pdfDownload PDFimage_print

WASHINGTON — The FDA approved a new two-drug combo for certain HIV patients, as well as the first epinephrine auto-injector for infants.

FDA Gives Nod to Two-Drug HIV Combo

For some people with HIV, the long-established three-drug treatment paradigm has been upset, with FDA approval of a new single-pill regimen that contains only two medications.

But the combination of dolutegravir (Tivicay), and rilpivirine (Edurant) — to be marketed as Juluca — isn’t for everyone, the FDA cautioned. Only patients whose infection has been suppressed for at least 6 months on a standard three-drug regimen — and who have neither a history of treatment failure nor any HIV mutations associated with resistance to either dolutegravir or rilpivirine — will be eligible to use the new combination.

“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” Debra Birnkrant, MD, of the FDA Center for Drug Evaluation and Research, said in a statement announcing the approval.

Opioids: FDA Issues New Guidance

The FDA on Tuesday issued a final guidance document to help companies develop generic versions of approved abuse-deterrent opioids.

FDA Commissioner Scott Gottlieb, MD, said in a statement that the guidance was “one piece of the FDA’s ongoing work aimed at finding solutions to combat the opioid crisis.”

Although the agency would ultimately like to reduce the number of people addicted to opioids by decreasing exposure to them, “we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives,” said Gottlieb. “Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence.”

The FDA has so far approved 10 abuse-deterrent opioid formulations, but uptake has been slow, he noted. “The reason for their more limited use is likely multifold. We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions.”

Less Waste Means Better Healthcare, Expert Advises

Eliminating waste in the healthcare system to curb healthcare costs is truly possible, a health policy expert advised.

“The United States has spent $3.4 trillion dollars on care delivery, and I’m suggesting that half of that is recoverable waste, potentially,” said Brent James, MD, senior fellow at the Institute for Healthcare Improvement, and former Chief Quality Officer of Intermountain Health, in a talk at the American Enterprise Institute on Monday.

James, a contributor to the “To Err is Human: Building a Safer Health System” from the National Academies of Sciences, Engineering, and Medicine, argued that “any competent care delivery team” needs to focus on eliminating waste in the healthcare system. He said the rewards of such a strategy are “dramatically higher” than more traditional revenue enhancement strategies, such as increasing the volume of laboratory tests and scans.

FDA OKs Epinephrine Auto-Injector for Small Children

The FDA has approved the first epinephrine auto-injector specifically designed for infants and small children weighing 16.5 to 33 lbs, Kaléo, the device’s manufacturer, announced Monday.

The AUVI-Q 0.1 mg device is “specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 lbs (7.5 to 15 kg) who are at risk for or have a history of serious allergic reactions,” the company said in a press release.

“Until now, healthcare practitioners and caregivers to infants and small children have not had an epinephrine auto-injector with an appropriate dose of epinephrine available to them, potentially causing some delay in the administration of epinephrine in a life-threatening allergic emergency,” said Vivian Hernandez-Trujillo, MD, a pediatric allergist at Nicklaus Children’s Hospital in Miami, in the release.

“Having an epinephrine auto-injector with a needle length and dose specifically designed for infants and small children should help alleviate concerns around hitting the bone or injecting too much epinephrine.”

Next Week

The Coalition to Transform Advanced Care (C-TAC) will host the National Summit on Advanced Illness Care from Monday to Wednesday.

On Tuesday, the House Committee on Oversight and Government Reform will explore strategies for fighting the opioid crisis at a field hearing in Baltimore.

On Wednesday, the Senate Help, Education, Labor, and Pensions (HELP) Committee will discuss the nomination of Alex Azar to lead the U.S. Department of Health and Human Services.

On Thursday, the Senate HELP Committee will hear from government and medical experts on the front lines of the opioid epidemic. And a subcommittee for the House Committee on Energy & Commerce will examine the impact of the 21st Century Cures Act.

Also, Health Affairs will host a discussion on workplace satisfaction among physicians.

On Thursday and Friday, the FDA’s Blood Products Advisory Committee will discuss “bacterial risk control strategies for blood collection establishments and transfusion services.”

On Friday, the Alliance for Health Policy will discuss the future of Medicare payment.

2017-11-25T11:00:00-0500

Tagged with:

About author

Related Articles