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Health Highlights: Sept. 1, 2017

Posted four days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: FDA OKs Fresh Antibacterial Drug The U.S. Food and Drug Administration on Tuesday gave its approval to Vabomere, a fresh intravenous bacteria-fighting drug for people with “complicated” urinary tract infections. Those UTIs include a kidney infection known as pyelonephritis, which is caused by specific bacteria, the.

Back to School, Back to Planning for Kids With Autism, ADHD

Posted today in Medical

MONDAY, Sept. Four, two thousand seventeen — The begin of a fresh school year isn’t always effortless, especially for kids with developmental and behavioral issues, such as autism and attention-deficit/hyperactivity disorder. Parents of these children may also have concerns about what lies ahead for their youngsters. But keeping a positive outlook is significant for a slick transition, according to Dr. Anson Koshy. “Commencing a fresh school.

Marching Band Members Can Use a Physical Tuneup

Posted today in Medical

MONDAY, Sept. Four, two thousand seventeen — School marching band members are athletic performers who must be physically fit to manage their routines and fancy footwork, experts say. “These athletes participate in rigorous practices to ideal routines for game day while wearing strenuous uniforms in hot, humid conditions,” said Mary Mundrane-Zweiacher, an athletic trainer and certified arm therapist. They have unique needs in terms of.

Antibacterial Scrubs for Nurses No Match for Germs

Posted today in Medical

MONDAY, Sept. Four, two thousand seventeen — Special antibacterial scrubs for nurses don’t fend off germs any better than traditional nursing garb, a fresh probe finds. “Health care providers must understand that they can become contaminated by their patients and the environment near patients. Albeit not effective, we looked to eliminate this risk for contamination by switching the material of nurses’ scrubs,” said lead probe author.

Get the Veggies, Skip the Starch

Posted today in Medical

MONDAY, Sept. Four, two thousand seventeen — Who doesn’t love a big serving of creamy mashed potatoes or a side of steamy rice with their chicken? They’re delicious, but it’s effortless to overindulge in these starchy, higher-calorie foods while falling brief on healthy vegetables. Attempt these ideas for wise substitutions that are lower in calories and carbs, but will still delight your taste buds and sate your appetite. Begin with.

FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia

September 1, two thousand seventeen — The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with freshly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged two years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial.

Monthly News Roundup – August 2017

Kymriah from Novartis Approved as Very first U.S. CAR-T Cell Therapy History was made this month as the U.S. Food and Drug Administration (FDA) approved the very first U.S. cell-based gene therapy known collectively as chimeric antigen receptor (CAR) T-cell therapy. Kymriah (tisagenlecleucel or CTL019) from Novartis was approved for the treatment of patients up to twenty five years of age with B-cell precursor acute lymphoblastic.

FDA Approves Genentech`s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome

South San Francisco, CA — August 30, two thousand seventeen — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) intravenous injection for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older. CRS, which is .

Teva Announces FDA Approval of Austedo (deutetrabenazine) Tablets for the Treatment of Tardive Dyskinesia in Adults

JERUSALEM–(BUSINESS WIRE) August 30, two thousand seventeen –Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved Austedo (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. Austedo was previously approved for the treatment of chorea associated with Huntington`s disease in April 2017. Tardive dyskinesia is a debilitating a.

FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia

August 30, two thousand seventeen — The U.S. Food and Drug Administration issued a historic activity today making the very first gene therapy available in the United States, ushering in a fresh treatment to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and youthfull adult patients with a form of acute lymphoblastic leukemia (ALL). «We`re coming in a fresh.

Lilly to File Baricitinib Resubmission to U.S. FDA Before End of January 2018

INDIANAPOLIS, Aug. 30, two thousand seventeen /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the Fresh Drug Application (NDA) for baricitinib before the end of January 2018. The resubmission package will include fresh safety and efficacy data. The companies anticipate the.

FDA Approves Vabomere (meropenem and vaborbactam) for Complicated Urinary Tract Infections

August 29, two thousand seventeen — The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. «The FDA is committed to making fresh safe and e.

Sorrento Therapeutics, Inc. Submits NDA For ZTlido Next-Generation Lidocaine Patch

SAN DIEGO, Aug. 29, two thousand seventeen /PRNewswire/ — Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (“Sorrento”), announced today that SCILEX Pharmaceuticals Inc. (“SCILEX”), a majority-owned subsidiary of Sorrento, resubmitted the NDA and responded to all of FDA comments related to the initial NDA subordination for its lead product candidate, ZTlido™ (lidocaine patch 1.8%). ZTlido is a next-generation non-opioid, lidocaine patch c.

Apricus Biosciences Files NDA Resubmission for Vitaros

SAN DIEGO, Aug. 29, two thousand seventeen (GLOBE NEWSWIRE) — Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported that it recently filed its resubmission of a Fresh Drug Application («NDA») for Vitaros™ (alprostadil, DDAIP.HCl) with the U.S. Food and Drug Administration («FDA»). Apricus anticipates a six-month review by the FDA with a projected.

Acorda Receives Refusal to File Letter from FDA for Inbrija (CVT-301, levodopa inhalation powder) Fresh Drug Application

ARDSLEY, N.Y.–(BUSINESS WIRE)–August 29, two thousand seventeen — Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its Fresh Drug Application (NDA) for Inbrija. Inbrija is an investigational treatment for symptoms of OFF periods in people with Parkinson`s disease taking a carbidopa/levodopa regimen. Upon its p.

La Jolla Pharmaceutical Company Announces U.S. FDA Acceptance of Fresh Drug Application for LJPC-501

SAN DIEGO–(BUSINESS WIRE)–Aug. 28, 2017– La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company`s Fresh Drug Application (NDA) for the investigational drug LJPC-501 (angiotensin II) for the treatment of hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite f.

FDA provides fresh devices for the development and decent evaluation of tests for detecting Zika virus infection

August 17, two thousand seventeen — As an extra measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect latest Zika virus infection. «At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with .

FDA Warns of Potential Contamination in Numerous Brands of Drugs, Dietary Supplements

August 11, two thousand seventeen — The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient.

Monthly News Roundup – July 2017

FDA Approves Gilead`s Vosevi for Six Hepatitis C Genotypes The U.S. Food and Drug Administration (FDA) has approved Gilead`s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for retreatment of adults with chronic hepatitis C virus (HCV) of two types: either genotype 1, Two, Three, Four, Five, or six previously treated with an NS5A inhibitor regimen, or genotype 1a or four previously treated with a sofosbuvir regimen without an NS.

FDA Clears Very first Neonatal Magnetic Resonance Imaging Device

July 20, two thousand seventeen — Today, the U.S. Food and Drug Administration cleared the very first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). «Albeit we can use traditional MRI scanners to pic neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents good challenges,» said Vasum Peiris, M.D., M.P.H., chief med.

Bayer Announces Enrolment of Very first U.S. Patient in Phase III trials of Vilaprisan in Uterine Fibroids

WHIPPANY, N.J., Aug. 29, two thousand seventeen /PRNewswire/ — Bayer announced that the very first U.S. patient has been enrolled in ASTEROID (Assess Safety and Efficacy of Vilaprisan in Subjects with UTERine FibrOIDs) – a Phase III clinical trial program assessing the safety and efficacy of vilaprisan, an oral and selective progesterone receptor modulator (SPRM), in women with symptomatic uterine fibroids.1,Two “Bayer has a rich l.

Merck Announces Results of Expose Outcomes Explore of Anacetrapib, Investigational Medicine for Cardiovascular Disease

KENILWORTH, N.J.–(BUSINESS WIRE) August 29, two thousand seventeen –Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, and researchers in the Clinical Trial Service Unit at the University of Oxford, today announced the publication and presentation of results from the Expose (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes examine of anacetrapib, Merck`s investigational cholesteryl e.

FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo`s DS-8201 for HER2-Positive Metastatic Breast Cancer

Tokyo, Japan, Basking Ridge, NJ, and Munich, Germany – (August 29, 2017) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who.

Fresh, One-Year Data from ORION-1 Phase II Probe of Inclisiran Extends Excellent Long-Term Efficacy and Safety Profile, Affirming Dose for Phase III Trials

PARSIPPANY, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 28, 2017– The Medicines Company (NASDAQ: MDCO) and Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) today announced fresh, positive data from the ORION-1 Phase II explore of inclisiran, an investigational, first-in-class PCSK9 synthesis inhibitor being developed for the treatment of hypercholesterolemia. The data were introduced today in the «Hot Line – Lat.

Biogen Reports Fresh Data from Phase 1b Probe of Investigational Alzheimer`s Disease Treatment Aducanumab

CAMBRIDGE, Mass.–(BUSINESS WIRE)– August 28, two thousand seventeen Biogen (NASDAQ: BIIB) today announced results from a recently conducted analysis of the long-term extension (LTE) of its ongoing Phase 1b examine of aducanumab, the company`s investigational treatment for early Alzheimer`s disease. The updated analyses include data from the placebo-controlled period and LTE for patients treated with aducanumab up to twenty four months in th.

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