Uno Healthcare
UNO HEALTHCARE was established in 1996 as a pharmaceutical...
Monthly News Roundup – February 2015
Sanofi Receives FDA Approval for Basal Insulin Toujeo The U.S. Food and Drug Administration has approved Sanofi’s Toujeo (insulin glargine [rDNA origin], a once-daily long-acting basal insulin for adults with type 1 or type 2 diabetes. In the clinical trials evaluating Toujeo, all of the primary study endpoints were met by demonstrating similar blood sugar control with Toujeo as compared
Monthly News Roundup – March 2015
FDA Approves First Biosimilar Product Zarxio On Friday, March 6th the U.S. Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim-sndz), the first U.S. approved biosimilar. Zarxio, the biosimilar for Amgen’s filgrastim (Neupogen), is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments. Biological products are generally derived from a living organism, including humans,
In Fight Against Zika Virus, Officials Consider Genetically Modified Mosquitoes
TUESDAY Feb. 16, 2016, 2016 — As the Zika virus continues to spread fear and potentially devastating health problems throughout Latin America and the Caribbean, scientists are weighing the use of a controversial weapon — genetically modified mosquitoes. The mosquito-borne Zika virus is thought — but not proven — to be behind an epidemic of
Cholesterol in Eggs May Not Hurt Heart Health: Study
TUESDAY Feb. 16, 2016, 2016 — The once-maligned egg may not be a heartbreaker after all, new research suggests. Finnish say that even carriers of a gene — called APOE4 — that increases sensitivity to dietary cholesterol don’t seem to have anything to fear when it comes to the impact of eggs, or any other
FDA Approves Taltz
FDA Approves Taltz (ixekizumab) for Plaque Psoriasis March 22, 2016 — The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. Psoriasis is a skin condition that causes patches of skin redness and flaking. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of
FDA Approves Cinqair
FDA Approves Cinqair (reslizumab) to Treat Severe Asthma March 23, 2016 — The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite
FDA Approves Defitelio
FDA Approves Defitelio (defibrotide sodium) for Hepatic Veno-Occlusive Disease Following Hematopoietic Stem-Cell Transplantation March 30, 2016 — The U.S. Food and Drug Administration today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or
FDA allows use of investigational test to screen blood donations for Zika virus
March 30, 2016 — The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus. “The availability of an
Monthly News Roundup – March 2016
FDA Approves Teva’s Cinqair to Treat Severe Asthma In March, the U.S. Food and Drug Administration (FDA) approved Teva’s Cinqair (reslizumab) as an adjunct for the maintenance treatment of severe asthma in adults not well-controlled on their current asthma medications. Cinqair is an interleukin 5 (IL-5) antagonist monoclonal antibody (IgG4 kappa) given once every four weeks via infusion in a clinical
Social Groups May Lengthen Retirees’ Lives
TUESDAY Feb. 16, 2016, 2016 — Staying socially active by joining book clubs or church groups may add years to your life after retirement, a new study suggests. The more groups a person belongs to in early retirement, the lower their risk of premature death, Australian researchers found. The chance of dying within six years
FDA Expands Use of Xalkori (crizotinib) to Treat ROS-1 Positive Non-Small Cell Lung Cancer
March 11, 2016 — The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Xalkori is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC. Lung cancer is the leading cause of cancer-related deaths in the United
Study: You Can Predict Which Male Teens Will Live With Their Future Kids
TUESDAY Feb. 16, 2016, 2016 — It’s possible to determine how likely it is that male teens will live with their future children, researchers report. This can be done by assessing a male teen’s attitudes about risky sex, pregnancy and birth control. Those less concerned about risky sex were 30 percent less likely to live
Health Tip: Pay Attention While Walking
— Walking while distracted can be as dangerous as distracted driving. To avoid walking while distracted, the American Academy of Orthopaedic Surgeons advises: If you’re listening to a radio, phone or music player, lower the volume so you can hear surrounding noise and nearby traffic. Move away from pedestrian traffic if you need to make
FDA Approves Imbruvica (ibrutinib) for the First-Line Treatment of Chronic Lymphocytic Leukemia
NORTH CHICAGO, Ill., March 4, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL).1 The approval is based on data from the randomized, multi-center, open-label Phase 3 RESONATE™-2 (PCYC-1115) trial, which evaluated
FDA Approves Evomela
FDA Grants Spectrum Pharmaceuticals Approval of Evomela (melphalan) for Injection HENDERSON, Nev., March 15, 2016 –(BUSINESS WIRE)–Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted approval of Evomela for
FDA Approves Kovaltry
FDA Approves Bayer’s Kovaltry (Antihemophilic Factor (Recombinant)) for the Treatment of Children and Adults with Hemophilia A WHIPPANY, N.J., March 17, 2016 /PRNewswire/ — The U.S. Food and Drug Administration has approved Bayer’s Kovaltry Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval
Monthly News Roundup – February 2016
Briviact Wins FDA Approval As Adjunct for Partial Onset Seizures Epilepsy is a brain disorder that causes people to have recurring seizures, consisting of uncontrollable muscle movements, abnormal sensations or thinking. The U.S. Food and Drug Administration (FDA) has approved Briviact (brivaracetam) as an add-on treatment for partial onset seizures in patients age 16 years and older with epilepsy. Briviact (brivaracetam)
Health Tip: Is Your Child Stressed?
— Children and teens aren’t immune to stress. But can parents recognize the warning signs? The American Psychological Association mentions these potential symptoms: Acting moody or withdrawn. Having sleep or appetite changes. Clinging to parents. Avoiding activities that used to excite the child. Complaining frequently of headache or stomachache without an apparent cause. Behaving unusually
FDA Approves Odefsey
FOSTER CITY, Calif.–(BUSINESS WIRE)–Mar. 1, 2016– Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen
FDA Approves Xeljanz XR
Pfizer Announces FDA Approval of Xeljanz XR (tofacitinib citrate), the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis February 24, 2016 — Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in
FDA Approves Briviact
February 19, 2016 — The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy. Epilepsy is a brain disorder that causes people to have recurring seizures. A seizure is an episode, usually of relatively short duration,
Pfizer Receives Expanded FDA Approval For Ibrance (palbociclib) In HR+, HER2- Metastatic Breast Cancer
Friday, February 19, 2016 — Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of Ibrance (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy. Now Ibrance also is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)
Monthly News Roundup – January 2016
Merck’s Once-Daily Zepatier for Hepatitis C Wins Approval Hepatitis C virus (HCV) affects over 3 millions Americans, and may lead to liver impairment, cirrhosis or even liver failure. In January, the U.S. Food and Drug Administration (FDA) approved the oral treatment Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis Cvirus (HCV) genotypes 1 (the
FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States
February 16, 2016 — As a safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a
Health Tip: Let Kids Prepare Breakfast
— Breakfast is the most important meal of the day, and it’s a good idea to have kids create their own nutritious start. The Academy of Nutrition and Dietetics offers these ideas for what to include: A slice of whole-wheat toast, served with a slice of cheese and 100 percent whole-fruit juice. Milk with iron-fortified
FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C
PRINCETON, N.J., February 5, 2016 –(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat
FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease
FOSTER CITY, Calif.–(BUSINESS WIRE)–Feb. 16, 2016– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis