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Opdivo delivers superior five-year survival results in renal cell carcinoma

The company said that 26% of patients with previously treated advanced or metastatic renal cell carcinoma are alive at five years of treatment with Opdivo. According to Bristol-Myers

The post Opdivo delivers superior five-year survival results in renal cell carcinoma appeared first on Pharmaceutical Business review.


Celltrion showcases positive one-year results for subcutaneous formulation of infliximab in patients with active Crohn’s disease and ulcerative colitis

Results presented at The European Crohn’s and Colitis Organisation (ECCO) 2020 annual congress in Vienna, Austria demonstrated that the SC formulation of CT-P13 was comparable to the IV

The post Celltrion showcases positive one-year results for subcutaneous formulation of infliximab in patients with active Crohn’s disease and ulcerative colitis appeared first on Pharmaceutical Business review.


New phase 3b interim data from STARDUST study show majority patients with moderately to severely active Crohn’s Disease achieved clinical remission after two doses of STELARA

Intestinal ultrasound (IUS) responses were assessed and were detected as early as week 4.2 Week 16 data (digital oral presentation or DOP 13) and IUS response data (DOP

The post New phase 3b interim data from STARDUST study show majority patients with moderately to severely active Crohn’s Disease achieved clinical remission after two doses of STELARA appeared first on Pharmaceutical Business review.


Epizyme seeks FDA accelerated approval for Tazverik to treat follicular lymphoma

The regulator has accepted the firm’s new drug application (NDA) for the accelerated approval of tazemetostat to treat patients with relapsed or refractory FL who have secured at

The post Epizyme seeks FDA accelerated approval for Tazverik to treat follicular lymphoma appeared first on Pharmaceutical Business review.


Seattle Genetics gets FDA priority review for tucatinib in locally advanced or metastatic HER2-positive breast cancer

This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients

The post Seattle Genetics gets FDA priority review for tucatinib in locally advanced or metastatic HER2-positive breast cancer appeared first on Pharmaceutical Business review.


The US FDA accepts for priority review Bristol-Myers Squibb’s BLA for liso-cel for adult patients with relapsed or refractory large B-cell lymphoma

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 17, 2020. “There remains a critical need for additional therapies in large B-cell

The post The US FDA accepts for priority review Bristol-Myers Squibb’s BLA for liso-cel for adult patients with relapsed or refractory large B-cell lymphoma appeared first on Pharmaceutical Business review.


Roche gets Chinese approval for Tecentriq plus chemotherapy to treat ES-SCLC

Tecentriq is a monoclonal antibody designed to bind with PD-L1 protein that is expressed on tumour cells and tumour-infiltrating immune cells, restricting its interactions with both PD-1 and

The post Roche gets Chinese approval for Tecentriq plus chemotherapy to treat ES-SCLC appeared first on Pharmaceutical Business review.


ALX Oncology announces closing of $105m Series C financing

Vivo Capital was the lead investor with other new investors including funds managed by Logos Capital, Janus Henderson, Foresite Capital, Cormorant Asset Management, BVF Partners, and investor HBM

The post ALX Oncology announces closing of $105m Series C financing appeared first on Pharmaceutical Business review.


Deciphera Pharmaceuticals announces US FDA acceptance of NDA and priority review for ripretinib in patients with advanced gastrointestinal stromal tumours

The FDA granted Priority Review for the NDA, which provides for a six-month review, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of August

The post Deciphera Pharmaceuticals announces US FDA acceptance of NDA and priority review for ripretinib in patients with advanced gastrointestinal stromal tumours appeared first on Pharmaceutical Business review.


Merck’s Keytruda plus chemotherapy meets primary endpoint in mTNBC trial

Keytruda plus chemotherapy achieved one of its dual primary endpoints of PFS in patients with mTNBC whose tumours expressed PD-L1. Keytruda, an anti-PD-1 therapy, works by blocking the

The post Merck’s Keytruda plus chemotherapy meets primary endpoint in mTNBC trial appeared first on Pharmaceutical Business review.


Drugs.com - News for Health Professionals
Headline news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

FDA Requests Market Withdrawal of Belviq Due to Cancer Risk
FRIDAY, Feb. 14, 2020 -- A clinical trial of the weight-loss drug Belviq (lorcaserin) shows an association with an increased risk for cancer, and the U.S. Food and Drug Administration is requesting that its maker withdraw the drug from the U.S....
CDC: Coronavirus Spreads Most Easily When Patients Are Sickest
FRIDAY, Feb. 14, 2020 -- Coronavirus is most infectious when patients are at the peak of their illness, health officials from the U.S. Centers for Disease Control and Prevention said Friday. "Based on what we know now, we believe this virus spreads...
Medtronic MiniMed 600 Series Insulin Pumps Recalled
FRIDAY, Feb. 14, 2020 -- More than 322,000 MiniMed 600 Series Insulin Pumps have been recalled by Medtronic due to a defect that could cause them to malfunction and put users at risk for serious harm or death. The recalled devices lack or have a...
U.S. Life Expectancy to Reach 85 by 2060
FRIDAY, Feb. 14, 2020 -- Nearly a quarter of all U.S. residents will be older than 65 by 2060, and life expectancy will reach an all-time high of 85 by that year, according to the U.S. Census Bureau. The bureau says that the increase in life...
Telemarketer Access to Medicare Information to Be Investigated
FRIDAY, Feb. 14, 2020 -- An investigation into how telemarketers may be obtaining seniors' personal Medicare information will be launched by the U.S. Health and Human Services inspector general office. The audit will be announced next week, an...
Cool Water for 20 Minutes After Pediatric Burn Improves Outcomes
FRIDAY, Feb. 14, 2020 -- Cooling children's burns with running water improves clinical outcomes, according to a study published in the January issue of the Annals of Emergency Medicine. Bronwyn R. Griffin, Ph.D., from Queensland University of...
Short-Course Rifamycin-Based Regimens Preferred for Latent TB
FRIDAY, Feb. 14, 2020 -- For treatment of latent tuberculosis infection (LTBI), short-course rifamycin-based regimens are preferred over longer-course isoniazid monotherapy, according to guidelines published in the Feb. 14 issue of the U.S. Centers...
Perinatal Outcomes Poorer With Cryopreserved Donor Oocytes
FRIDAY, Feb. 14, 2020 -- For women undergoing in vitro fertilization (IVF), use of cryopreserved versus fresh donor oocytes is associated with marginally, but statistically significant, lower odds of a good perinatal outcome, according to a study...
Cocoa Consumption May Improve Walking Performance in PAD
FRIDAY, Feb. 14, 2020 -- Cocoa consumption may improve walking performance in individuals with peripheral artery disease (PAD), according to a study published online Feb. 14 in Circulation Research. Mary M. McDermott, M.D., from the Northwestern...
Thoracic Radiation May Increase Fatigue, Dyspnea in Short Term
FRIDAY, Feb. 14, 2020 -- Thoracic radiation therapy (RT) is associated with increased fatigue and dyspnea as well as decreased physical activity, according to a study presented at the Cardiovascular Care of the Oncology Patient conference organized...
Exposure to PM2.5 Tied to Out-of-Hospital Cardiac Arrest
FRIDAY, Feb. 14, 2020 -- Short-term exposure to fine particulate matter (PM2.5) is associated with an increased risk for out-of-hospital cardiac arrest (OHCA), according to a study published in the January issue of The Lancet Planetary Health. Bing...
Teens With ADHD Less Likely Than Preteens to Have Doctor Visit
FRIDAY, Feb. 14, 2020 -- Children with attention-deficit/hyperactivity disorder (ADHD) are less likely to have a primary care visit during adolescence than preadolescence, according to a study published in the February/March issue of the Journal of...
Having More Sexual Partners Tied to Increased Odds of Cancer
FRIDAY, Feb. 14, 2020 -- The odds of reporting cancer are increased for men and women with a history of 10 or more lifetime sexual partners, according to a study published online Feb. 13 in BMJ Sexual & Reproductive Health. Igor Grabovac, M.D.,...
Massachusetts Health Reform Tied to Decrease in Advanced Cancer
FRIDAY, Feb. 14, 2020 -- Following state health reform, there was a decline in advanced-stage colorectal cancer (CRC) diagnoses in Massachusetts, according to a study published in the February issue of Medical Care. Lindsay M. Sabik, Ph.D., from the...
2010 to 2017 Saw >5,000 Travel-Linked Dengue Virus Cases in U.S.
FRIDAY, Feb. 14, 2020 -- During 2010 to 2017, there were 5,009 travel-associated and 378 locally acquired confirmed or probable dengue virus cases in the United States, according to research published in the Feb. 14 issue of the U.S. Centers for...
Subconcussive Head Impacts May Affect Neuro-Ophthalmologic Function
THURSDAY, Feb. 13, 2020 -- Repetitive subconcussive head impacts may cause short-term impairment of neuro-ophthalmologic function, according to a study published online Feb. 13 in JAMA Ophthalmology. Madeleine K. Nowak, from the Indiana University...
2002 to 2015 Saw Increase in Incidence of Diabetes in Youth
THURSDAY, Feb. 13, 2020 -- From 2002 to 2015, there was a constant increase in the incidence of type 1 and type 2 diabetes among youth, according to research published in the Feb. 14 issue of the U.S. Centers for Disease Control and Prevention...
CDC: Some Coronavirus Testing Kits Sent to States Are Faulty
THURSDAY, Feb. 13, 2020 -- Some coronavirus testing kits sent to state laboratories across the United States are flawed and do not provide accurate results, the U.S. Centers for Disease Control and Prevention said Wednesday. Kits were sent to every...
Less Than Half of Kidney Disease Quality Metrics Rated Highly Valid
THURSDAY, Feb. 13, 2020 -- Less than half of the existing 60 kidney disease quality metrics are rated with high validity, according to a study published online Feb. 13 in the Journal of the American Society of Nephrology. Mallika L. Mendu, M.D.,...
No Sign of Vertical Transmission of COVID-19 Found in Late Pregnancy
THURSDAY, Feb. 13, 2020 -- There currently is no evidence of intrauterine infection caused by vertical transmission in women who develop 2019 novel coronavirus disease (COVID-19) pneumonia in late pregnancy, according to research published online...
Many Dermatologists Not Ready to Respond to Biological Attacks
THURSDAY, Feb. 13, 2020 -- Many dermatologists report that they are not adequately prepared to deal with biological attacks and other manmade disasters, according to a study published in the February issue of the Journal of Drugs in...
Sedentary Behavior, Activity Linked to Depression at Age 18
THURSDAY, Feb. 13, 2020 -- Sedentary behavior throughout adolescence is associated with the risk for depressive symptoms at age 18 years, according to a study published online Feb. 11 in The Lancet Psychiatry. Aaron Kandola, from the University...
Orthostatic Hypotension During HTN Tx Not Tied to CVD Events
THURSDAY, Feb. 13, 2020 -- Orthostatic hypotension (OH) during hypertension treatment is not associated with a higher risk for cardiovascular disease events, according to a study published online Jan. 27 in Hypertension. Stephen P. Juraschek, M.D.,...
More Lung Cancer Patients Presenting With Cough, Dyspnea
THURSDAY, Feb. 13, 2020 -- The proportion of lung cancer patients with an index symptom of cough or shortness of breath has increased over time, according to a study published online Jan. 27 in the British Journal of General Practice. Sarah...
Caregivers Are in Need of Better Health Care Coverage, Access
THURSDAY, Feb. 13, 2020 -- Unpaid adult caregivers are at higher risk for not having insurance and putting off necessary health services due to cost, according to a study recently published in Rehabilitation Psychology. Jamie L. Tingey, from Seattle...
Bariatric Surgery May Cut Risk for Colorectal Cancer in Obese Patients
THURSDAY, Feb. 13, 2020 -- Among obese individuals,those who undergo bariatric surgery have an approximately 35 percent lower risk for developing colorectal cancer than those who do not undergo surgery, according to a review and meta-analysis...
Risk for Complications From Mesh Implant Does Not Diminish
THURSDAY, Feb. 13, 2020 -- Continued surveillance after mesh use in pelvic organ prolapse (POP) repairs is necessary, according to a study published online Feb. 6 in Obstetrics & Gynecology. Bilal Chughtai, M.D., from Weill Cornell Medical...
Smartphone, Web App May Help Predict Prognosis for Meningioma
THURSDAY, Feb. 13, 2020 -- An open-source smartphone and web application has been developed to help predict clinical malignancy and survival outcomes for meningioma, according to a study published online Jan. 30 in npj Digital Medicine. Jeremy T....
Coronavirus Cases, Deaths Rise Sharply
THURSDAY, Feb. 13, 2020 -- After charting a slight decline in spread earlier this week, new coronavirus cases in China jumped by almost 15,000 in a single day, while the death count spiked to 1,367, Chinese health officials reported Thursday,...
Use of Revascularization Up for Critical Limb Ischemia in Veterans
THURSDAY, Feb. 13, 2020 -- For veterans, the incidence of critical limb ischemia decreased from 2005 to 2013, while use of revascularization increased from 2005 to 2014, according to a study published online Feb. 13 in Circulation: Cardiovascular...
Coronavirus Spread Slows, but Death Toll Jumps to 1,113
WEDNESDAY, Feb. 12, 2020 -- While the number of new cases of coronavirus in China slowed on Wednesday, the death count has now risen to 1,113, Chinese health officials reported. Those totals far exceed the toll of the 2003 SARS outbreak, in which...
Congo Ebola Outbreak Seems to Be Easing
WEDNESDAY, Feb. 12, 2020 -- Experts are "very encouraged" after just three new Ebola cases were reported in the past week in eastern Congo, World Health Organization Director-General Tedros Adhanom Ghebreyesus said Tuesday. It is an indication that...
2011 to 2018 Saw Decline in Problems Paying Medical Bills
WEDNESDAY, Feb. 12, 2020 -- From 2011 to 2018, there was a decrease in the percentage of families having problems paying medical bills in the past 12 months, according to a February data brief published by the U.S. Centers for Disease Control and...
Recommendations Issued for Sleep Disturbance in Pediatric Autism
WEDNESDAY, Feb. 12, 2020 -- In an American Academy of Neurology practice guideline, published online Feb. 12 in Neurology, recommendations are presented for addressing sleep disturbances in children and adolescents with autism spectrum disorder...
Studies Explore Prevalence of Skin Cancer Among Sexual Minorities
WEDNESDAY, Feb. 12, 2020 -- The prevalence of skin cancer among sexual minorities and transgender and gender-nonconforming (TGNC) adults is explored in two studies published online Feb. 12 in JAMA Dermatology. Sean Singer, from Brigham and Women's...
ASA: Periodontal Disease Tied to Large-Artery Atherothrombotic Stroke
WEDNESDAY, Feb. 12, 2020 -- Periodontal disease (PD) is associated with large-artery atherothrombotic stroke, including stroke due to intracranial atherosclerosis (ICAS), and people with gingivitis are more likely to have ICAS, according to two...
High BMI May Cut Overall Survival in HER2+ Metastatic Breast Cancer
WEDNESDAY, Feb. 12, 2020 -- For patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (mBC) treated with pertuzumab and/or trastuzumab emtansine (T-DM1), a body mass index (BMI) of ≥30 kg/m² is...
2002 to 2018 Saw Increases in Heroin Use, Use Disorder, Injection
WEDNESDAY, Feb. 12, 2020 -- The prevalence of heroin use, heroin use disorder, and heroin injection increased from 2002 to 2018, according to a research letter published in the Feb. 11 issue of the Journal of the American Medical Association. Beth...
ASA: Herpes Zoster Vaccine May Reduce Risk for Stroke
WEDNESDAY, Feb. 12, 2020 -- Vaccination with zoster vaccine live (ZVL) is associated with a reduced risk for stroke among older adults, according to a study to be presented at the American Stroke Association International Stroke Conference, held...
Survival Similar for Hemodialysis, Peritoneal Dialysis
WEDNESDAY, Feb. 12, 2020 -- Peritoneal dialysis (PD) and in-center hemodialysis (HD) carry similar survival benefits, according to a review published online Jan. 28 in Nephrology Dialysis Transplantation. Mohamed E. Elsayed, M.B.B.S., from...

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