Health and Human Services News and Research

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FDA authorizes marketing of new Bose Hearing Aid

The U.S. Food and Drug Administration today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss).

5 Oct 2018

New approach could lead to precise treatments for traumatic brain injury

Traumatic head injury can have widespread effects in the brain, but now scientists can look in real time at how head injury affects thousands of individual cells and genes simultaneously in mice.

5 Oct 2018

Podcast: KHN’s ‘What the Health?’ Some things old, some things new

Congress passed major health-related legislation in time for the fiscal year, which began Monday, including a broad bill to address the opioid epidemic and a spending bill for the Department of Health and Human Services.

4 Oct 2018

Vaxart to present new data from Phase 2 Challenge Study of H1 influenza oral tablet vaccine

Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, announced it will present new data from the Phase 2 Challenge Study of its H1 influenza oral tablet vaccine at IDWeek 2018 in San Francisco on Saturday, October 6, 2018.

4 Oct 2018

Study suggests diet as major contributor for high risk of hypertension in black Americans

New findings suggest that diet is a major contributor for the increased risk of hypertension in black compared to white Americans.

4 Oct 2018

Genentech announces Phase III study results of baloxavir marboxil in people at high risk of flu

Genentech, a member of the Roche Group, today announced that the Phase III CAPSTONE-2 study showed treatment with baloxavir marboxil significantly reduced the time to improvement of influenza symptoms versus placebo in people at high risk of serious complications from the flu, which includes adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity, or heart disease.

4 Oct 2018

FDA permits marketing of ClonoSEQ assay to detect minimal residual disease in blood cancer patients

Today the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing-based test for minimal residual disease in patients with acute lymphoblastic leukemiaor multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person's bone marrow.

30 Sep 2018

FDA approves new drug for treatment of lung disease caused by Mycobacterium avium complex

The U.S. Food and Drug Administration today approved a new drug, Arikayce, for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex in a limited population of patients with the disease who do not respond to conventional treatment.

29 Sep 2018

Researchers examine factors associated with mortality post- traumatic brain injury

Model system researchers have examined the factors associated with mortality among individuals aged 16 years and older who were more than one year post- traumatic brain injury.

29 Sep 2018

FDA approves first intravenous treatment for metastatic cutaneous squamous cell carcinoma

The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

28 Sep 2018

Auto-FMT found to be safe, effective way to replenish beneficial gut bacteria in cancer patients

Researchers at Memorial Sloan Kettering Cancer Center have shown that autologous fecal microbiota transplantation (auto-FMT) is a safe and effective way to help replenish beneficial gut bacteria in cancer patients who require intense antibiotics during allogenic hematopoietic stem cell transplantation.

27 Sep 2018

NIAID releases strategic plan to expand knowledge of TB by using modern tools

Tuberculosis (TB) is the leading infectious cause of death worldwide, killing roughly 1.6 million people in 2017. In the past 200 years, TB claimed the lives of more than one billion people--more deaths than from malaria, influenza, smallpox, HIV/AIDS, cholera and plague combined.

27 Sep 2018

NIH-funded genome centers to speed up breakthroughs in precision medicine

The All of Us Research Program awarded funds totaling $28.6 million to establish three genome centers around the country. These centers will begin to generate genomic data from biosamples contributed by the program's participants.

26 Sep 2018

FDA grants Orphan Drug Designation to Myelo001 for treatment of Acute Radiation Syndrome

Myelo Therapeutics GmbH announced today that the US Food and Drug Administration has granted an Orphan Drug Designation to its orally applied new chemical entity Myelo001 for the treatment of Acute Radiation Syndrome.

25 Sep 2018

NIMHD-funded study to focus on hurricane-related psychosocial stressors

Eight new awards will help researchers examine the health impacts in Puerto Rico and the U.S. Virgin Islands following the physical damage and community-level hardships left by Hurricanes Irma and Maria in 2017.

24 Sep 2018

As states try to rein in drug spending, feds slap down one bold Medicaid move

States serve as “laboratories of democracy,” as U.S. Supreme Court Justice Louis Brandeis famously said. And states are also labs for health policy, launching all kinds of experiments lately to temper spending on pharmaceuticals.

21 Sep 2018

NIH launches clinical trial to test infusions of combination antibodies in people with HIV

A clinical trial testing infusions of combination antibodies in people living with HIV has begun at the National Institutes of Health.

20 Sep 2018

Podcast: KHN’s ‘What the Health?’ Health on the hill

As the start of the fiscal year draws near — along with pivotal midterm elections — Congress is picking up its pace on legislation. This week alone the Senate passed a comprehensive bill aimed at curbing the opioid epidemic and a nearly final bill to fund the Department of Health and Human Services.

20 Sep 2018

FDA takes new steps to address opioid crisis by approving Opioid Analgesic Risk Evaluation and Mitigation Strategy

Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy.

19 Sep 2018

FDA launches new comprehensive effort to educate kids about dangers of e-cigarettes

In the latest of a series of actions to address the epidemic of youth e-cigarette use, the U.S. Food and Drug Administration today launched "The Real Cost" Youth E-Cigarette Prevention Campaign, a new, comprehensive effort aimed at educating kids about the dangers of e-cigarettes.

18 Sep 2018

Health and Human Services News and Research

FDA authorizes marketing of new Bose Hearing Aid

New approach could lead to precise treatments for traumatic brain injury

Podcast: KHN’s ‘What the Health?’ Some things old, some things new

Vaxart to present new data from Phase 2 Challenge Study of H1 influenza oral tablet vaccine

Study suggests diet as major contributor for high risk of hypertension in black Americans

Genentech announces Phase III study results of baloxavir marboxil in people at high risk of flu

FDA permits marketing of ClonoSEQ assay to detect minimal residual disease in blood cancer patients

FDA approves new drug for treatment of lung disease caused by Mycobacterium avium complex

Researchers examine factors associated with mortality post- traumatic brain injury

FDA approves first intravenous treatment for metastatic cutaneous squamous cell carcinoma

Auto-FMT found to be safe, effective way to replenish beneficial gut bacteria in cancer patients

NIAID releases strategic plan to expand knowledge of TB by using modern tools

NIH-funded genome centers to speed up breakthroughs in precision medicine

FDA grants Orphan Drug Designation to Myelo001 for treatment of Acute Radiation Syndrome

NIMHD-funded study to focus on hurricane-related psychosocial stressors

As states try to rein in drug spending, feds slap down one bold Medicaid move

NIH launches clinical trial to test infusions of combination antibodies in people with HIV

Podcast: KHN’s ‘What the Health?’ Health on the hill

FDA takes new steps to address opioid crisis by approving Opioid Analgesic Risk Evaluation and Mitigation Strategy

FDA launches new comprehensive effort to educate kids about dangers of e-cigarettes

Event guide: 6th Operationalize Expanded Access Programs Summit East eBook

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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