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SanBio gets FDA RMAT designation for SB623 cell therapy

The status was provided based on clinical results of SB623, including the phase 2 study of modified stem cells in traumatic brain injury (STEMTRA) trial. SB623 is a

The post SanBio gets FDA RMAT designation for SB623 cell therapy appeared first on Pharmaceutical Business review.


Ironwood Pharmaceuticals and AstraZeneca amend LINZESS (linaclotide) collaboration in China

LINZESS was approved by the National Medical Products Administration for adults with IBS-C in China in January 2019. LINZESS is expected to be launched in China in the

The post Ironwood Pharmaceuticals and AstraZeneca amend LINZESS (linaclotide) collaboration in China appeared first on Pharmaceutical Business review.


Graybug Vision initiates clinical trial in macular edema secondary to diabetic macular edema or retinal vein occlusion

GB-102, a pan-Vascular Endothelial Growth Factor (VEGF) inhibitor and potential twice-per-year therapy is targeted to reduce the need for frequent intravitreal injections in retinal diseases, including wet AMD,

The post Graybug Vision initiates clinical trial in macular edema secondary to diabetic macular edema or retinal vein occlusion appeared first on Pharmaceutical Business review.


Roche gets FDA breakthrough therapy designation for Gazyva to treat lupus nephritis

The status was provided based on data from the phase II NOBILITY study in adult patients with proliferative lupus nephritis. Gazyva, in combination with standard of care (mycophenolate

The post Roche gets FDA breakthrough therapy designation for Gazyva to treat lupus nephritis appeared first on Pharmaceutical Business review.


Novartis’ Cosentyx meets primary endpoint at Week 16 in PREVENT trial

The PREVENT trial is assessing the efficacy and safety of Cosentyx compared to placebo with the primary endpoint being ASAS40 at Week 16. All the secondary endpoints of

The post Novartis’ Cosentyx meets primary endpoint at Week 16 in PREVENT trial appeared first on Pharmaceutical Business review.


Concert Pharmaceuticals completes enrollment in second open label trial of CTP-543 in alopecia areata

Topline data from this dose regimen trial is expected in the first half of 2020. “We are extremely grateful to the patients who volunteer to participate in our

The post Concert Pharmaceuticals completes enrollment in second open label trial of CTP-543 in alopecia areata appeared first on Pharmaceutical Business review.


FDA approves Keytruda plus Lenvima to treat advanced endometrial carcinoma

Keytruda is Merck’s anti-PD-1 therapy, while Lenvima is the orally available kinase inhibitor discovered by Eisai. Keytruda plus Lenvima has been approved for the treatment of patients with

The post FDA approves Keytruda plus Lenvima to treat advanced endometrial carcinoma appeared first on Pharmaceutical Business review.


Poxel initiates phase 1b multiple ascending dose trial for NASH drug candidate

This study aims to confirm the predicted relative exposure and dose proportionality of PXL065. PXL065, the deuterium-stabilized R-stereoisomer of pioglitazone, targets mitochondrial pyruvate carrier (MPC) inhibition. PXL065 is

The post Poxel initiates phase 1b multiple ascending dose trial for NASH drug candidate appeared first on Pharmaceutical Business review.


Alnylam initiates APOLLO-B phase 3 study of patisiran for treatment of transthyretin amyloidosis with cardiomyopathy

The primary endpoint is the change from baseline in the 6-minute walk test (6-MWT) at 12 months. Secondary endpoints will evaluate the efficacy of patisiran on quality of

The post Alnylam initiates APOLLO-B phase 3 study of patisiran for treatment of transthyretin amyloidosis with cardiomyopathy appeared first on Pharmaceutical Business review.


AstraZeneca’s Farxiga gets FDA fast track status in heart failure

The fast track designation is for the use of Farxiga in reducing the chances of cardiovascular (CV) death, or the worsening of heart failure, in adults with heart

The post AstraZeneca’s Farxiga gets FDA fast track status in heart failure 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.

Pediatricians Can Play Role in Cutting Sugary Drink Intake
FRIDAY, Sept. 20, 2019 -- Pediatricians have a role to play in encouraging children and adolescents to reduce sugary drink consumption, according to a policy statement recently published in Pediatrics. Noting that U.S. children and adolescents...
Colorectal Cancer Mortality Disparities Vary Across U.S. Cities
FRIDAY, Sept. 20, 2019 -- There is considerable variability in colorectal cancer (CRC) mortality disparities across urban cities, according to a study presented at the 12th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic...
11 Percent of Cancers Detected Via Emergency Department Visit
FRIDAY, Sept. 20, 2019 -- About 11 percent of cancers are diagnosed following an emergency department visit, according to a study presented at the 12th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the...
Liver Transplants Rarely Performed for Unauthorized Immigrants
FRIDAY, Sept. 20, 2019 -- Liver transplantation (LT) is rarely performed for unauthorized immigrants in the United States, according to a study published online Sept. 20 in Hepatology. Brian P. Lee, M.D., from the University of California in San...
Kidney Donation Linked to Increased Hypertension Risk
FRIDAY, Sept. 20, 2019 -- Kidney donation is associated with an increased risk for hypertension, according to a study published online Sept. 19 in the Clinical Journal of the American Society of Nephrology. Courtenay M. Holscher, M.D., from the...
Racial/Ethnic Disparities Seen in PrEP Awareness, Discussions
FRIDAY, Sept. 20, 2019 -- Considerable racial/ethnic disparities exist in HIV preexposure prophylaxis (PrEP) awareness, discussion, and use among men who have sex with men (MSM), according to research published in the Sept. 20 issue of the U.S....
Marijuana Use Common Among Adults With Medical Conditions
FRIDAY, Sept. 20, 2019 -- Marijuana use is common among adults with medical conditions, especially younger people, according to a study published online Sept. 20 in JAMA Network Open. Hongying Dai, Ph.D., from the University of Nebraska Medical...
CDC: Asthma Visit Rates Decreased From 2001 to 2016
FRIDAY, Sept. 20, 2019 -- Asthma is a common reason for physician visits, although the rate of asthma visits decreased from 2001 through 2016, according to a report published Sept. 20 by the U.S. Centers for Disease Control and Prevention National...
Sertraline Does Not Reduce Depressive Symptoms by Week 6
FRIDAY, Sept. 20, 2019 -- For patients with depression, sertraline does not reduce depressive symptoms at six weeks, but it does improve anxiety, mental health-related quality-of-life, and self-reported mental health, according to a study published...
Multifaceted Home-Based PT Does Not Aid Walking After Hip Fracture
FRIDAY, Sept. 20, 2019 -- A multicomponent home-based physical therapy intervention does not improve the ability of older patients recovering from hip fracture to walk again, according to a study published in the Sept. 10 issue of the Journal of the...
Rate of Opioid Rx Increasing for Incisional Ocular Surgery
FRIDAY, Sept. 20, 2019 -- The rate of filled opioid prescriptions is increasing for all types of incisional ocular surgery, according to a study published online Sept. 19 in JAMA Ophthalmology. Anton M. Kolomeyer, M.D., Ph.D., from the University of...
Cardiovascular Disease Risk Underestimated in Patients With Mental Illness
THURSDAY, Sept. 19, 2019 -- Cardiovascular disease (CVD) risk assessment tools that do not include severe mental illness as a predictor could be substantially underestimating CVD risk, according to a study published online Sept. 18 in PLOS ONE. Ruth...
Vaping-Linked Lung Illness Claims Eighth Life
FRIDAY, Sept. 20, 2019 -- A Missouri man in his 40s is the eighth person in the United States to die from complications of a lung injury tied to using electronic cigarettes, the Missouri Department of Health and Senior Services reported. "This is an...
SGLT2 Inhibitors Linked to Lower Risk for Heart Failure
WEDNESDAY, Sept. 18, 2019 -- Use of sodium glucose cotransporter 2 (SGLT2) inhibitors for type 2 diabetes is associated with a reduced risk for heart failure, but not a reduced risk for major cardiovascular events, compared with use of dipeptidyl...
CDC: Valley Fever Cases Increased From 2014 to 2017
THURSDAY, Sept. 19, 2019 -- Coccidioidomycosis is still a national public health problem, and the number of cases has increased in recent years, according to research published in the Sept. 20 issue of the U.S. Centers for Disease Control and...
Rates of Diabetes Higher at Lower BMIs Among Minorities
THURSDAY, Sept. 19, 2019 -- Even at lower body weights, members of certain racial and ethnic-minority groups have a higher prevalence of diabetes or prediabetes than whites, according to a study published online Sept. 19 in Diabetes Care. Yeyi Zhu,...
House Speaker Unveils Plan to Lower Drug Costs
THURSDAY, Sept. 19, 2019 -- House Speaker Nancy Pelosi has revealed a plan to lower the cost of medications for people on Medicare and those with private insurance. Under the plan, Medicare could bargain with drug companies to get the best prices on...
Maker Halts Distribution of Generic Zantac Due to Possible Carcinogen
THURSDAY, Sept. 19, 2019 -- Novartis, the maker of a generic form of Zantac, said Wednesday it will cease distribution of the medicine after investigations suggested that generic and branded versions contain a known carcinogen. A distribution halt...
CDC: Cases of Vaping-Linked Lung Illness Rise to 530 Across 38 States
THURSDAY, Sept. 19, 2019 -- The number of confirmed or suspected severe lung illnesses linked to vaping has risen to 530 cases across 38 states and the Virgin Islands, U.S. health officials reported Thursday. "Although the investigation continues,...
Increasing DTP3 Coverage Tied to Drop in Diphtheria Cases in Under 15s
THURSDAY, Sept. 19, 2019 -- The proportion of diphtheria case-patients younger than 15 years of age decreased as diphtheria-tetanus-pertussis (DTP) 3 coverage increased, according to a study published in the October issue of Emerging Infectious...
Few Trauma Patients Assessed for Effects of PTSD, Acute Stress
THURSDAY, Sept. 19, 2019 -- Few trauma patients are assessed for or educated about the potential effects of posttraumatic stress disorder (PTSD) or acute stress disorder (ASD), according to a study published in the September/October issue of the...
Linagliptin Noninferior for CV Risk in Early Type 2 Diabetes
THURSDAY, Sept. 19, 2019 -- Linagliptin is noninferior to glimepiride for adults with relatively early type 2 diabetes and elevated cardiovascular risk, according to a study published online Sept. 19 in the Journal of the American Medical...
CV Risk Lower With Metformin in T2DM + Reduced Kidney Function
THURSDAY, Sept. 19, 2019 -- Treatment with metformin versus sulfonylureas is associated with a reduced risk for major adverse cardiovascular events (MACE) among patients with type 2 diabetes and reduced kidney function, according to a study...
Many Hospitals, Practices Not Screening for Social Needs
THURSDAY, Sept. 19, 2019 -- Most hospitals and physician practices are not screening for five key social needs associated with health outcomes, according to a study published online Sept. 18 in JAMA Network Open. Taressa K. Fraze, Ph.D., from the...
Vaginal Mesh Hysteropexy No Better for Uterovaginal Prolapse
THURSDAY, Sept. 19, 2019 -- Among women with symptomatic uterovaginal prolapse, prolapse outcomes are similar after three years for vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension, according to a...
Frailty Assessment May Aid Liver Transplant Evaluation
THURSDAY, Sept. 19, 2019 -- A frailty assessment as part of liver transplant evaluation may help identify transplant candidates at higher risk for death, according to a study published online Sept. 11 in JAMA Surgery. Christine E. Haugen, M.D.,...
Skipping Cancer Referral Appointments Linked to Earlier Death
THURSDAY, Sept. 19, 2019 -- Cancer diagnosis is less likely in patients not attending referral appointments for suspected cancer, but these patients have worse early mortality outcomes than attending patients, according to a study published online...
ASTRO Issues Guideline for Radiation Tx in Pancreatic Cancer
THURSDAY, Sept. 19, 2019 -- In a new American Society for Radiation Oncology clinical practice guideline, published in the September-October issue of Practical Radiation Oncology, recommendations are presented for radiation treatment of pancreatic...
Medical Students Not Ready to Provide Nutritional Care
THURSDAY, Sept. 19, 2019 -- Medical education does not equip students to provide high-quality, effective nutrition care, according to a review published in the September issue of The Lancet Planetary Health. Jennifer Crowley, Ph.D., from the...
Seniors Should Undergo Annual Cognitive Health Assessment
WEDNESDAY, Sept. 18, 2019 -- Adults aged 65 years and older should undergo annual cognitive health assessments to improve recognition of mild cognitive impairment (MCI), according to a special article published online Sept. 18 in Neurology. Given...
New York State Institutes Ban on Flavored E-Cigarettes
WEDNESDAY, Sept. 18, 2019 -- Using his executive powers, New York Governor Andrew Cuomo is banning flavored electronic cigarettes in the state. The ban goes into effect immediately and makes New York the first state to institute such a regulation....
Anemia in Early Pregnancy May Harm Child Neurodevelopment
WEDNESDAY, Sept. 18, 2019 -- Anemia diagnosed during the first 30 weeks of pregnancy is associated with an increased risk for autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), and intellectual disability (ID),...
12.6 Million in U.S. Could Benefit From Tx to Prevent Active TB
WEDNESDAY, Sept. 18, 2019 -- An estimated 12.6 million persons in the United States could benefit from treatment to prevent active tuberculosis (TB), according to a report published in the October issue of Emerging Infectious Diseases, a publication...
Polypill Strategy Promising in Socioeconomically Vulnerable
WEDNESDAY, Sept. 18, 2019 -- In a socioeconomically vulnerable minority population, a combination pill (polypill) leads to greater reductions in systolic blood pressure and low-density lipoprotein (LDL) cholesterol levels, according to a study...
Electronic Nose Analysis May Predict Response to Anti-PD-1 Therapy in NSCLC
WEDNESDAY, Sept. 18, 2019 -- For patients with non-small cell lung cancer (NSCLC), responders and nonresponders can be differentiated by a metal oxide semiconductor electronic nose (eNose) analysis of exhaled breath before starting antiprogrammed...
Nonphysician Providers Rarely Interpret Diagnostic Images
WEDNESDAY, Sept. 18, 2019 -- Despite increasing roles of nonphysician providers (NPPs) in health care (nurse practitioners and physician assistants), they still rarely interpret diagnostic imaging studies, according to a study published online Sept....
Many Older Patients With AML Not Receiving Active Treatment
WEDNESDAY, Sept. 18, 2019 -- Many older patients with acute myeloid leukemia (AML) do not receive any active treatment, and they have worse survival than those receiving active treatment, according to a study published online Sept. 4 in Cancer. Amer...
Four Modifiable Risk Factors Tied to Hyperuricemia
WEDNESDAY, Sept. 18, 2019 -- Four modifiable risk factors -- body mass index (BMI), the Dietary Approaches to Stop Hypertension (DASH) diet, alcohol use, and diuretic use -- could individually account for a notable proportion of hyperuricemia and...
Migraines Linked to Higher Risk for Dementia, Alzheimer Disease
WEDNESDAY, Sept. 18, 2019 -- Migraines are a significant risk factor for Alzheimer disease (AD) and all-cause dementia, according to a study published online Sept. 4 in the International Journal of Geriatric Psychiatry. Rebecca E. Morton, from...
Hysterectomy Tied to Long-Term Risk for Depression, Anxiety
WEDNESDAY, Sept. 18, 2019 -- Hysterectomy, even with ovarian conservation, is associated with an increased long-term risk for de novo depression, according to a study published online Aug. 30 in Menopause. Shannon K. Laughlin-Tommaso, M.D., from the...

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