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US FDA accepts regulatory submission for Selumetinib

This is the first acceptance of a regulatory submission for an oral MEK 1/2 monotherapy for patients with NF1, a rare and incurable genetic condition. A Prescription Drug

The post US FDA accepts regulatory submission for Selumetinib appeared first on Pharmaceutical Business review.


EpicentRx closes $35m series D financing to support development of small molecule immunotherapy and oncolytic viral platform

The purpose of this funding round, which will be split into three tranches, is to progress the late-stage clinical development of EpicentRx’s lead anticancer agent, RRx-001, and proprietary

The post EpicentRx closes $35m series D financing to support development of small molecule immunotherapy and oncolytic viral platform appeared first on Pharmaceutical Business review.


Shionogi gets FDA approval for cUTI drug Fetroja

Fetroja has been approved for patients 18 years of age or older who have limited or no alternative treatment options to treat cUTI, including pyelonephritis. It can be

The post Shionogi gets FDA approval for cUTI drug Fetroja appeared first on Pharmaceutical Business review.


GSK’s mepolizumab succeeds in phase 3 trial in hypereosinophilic syndrome

The late-stage study evaluated subcutaneously administered mepolizumab 300mg (3x100mg) every four weeks against placebo in 108 adolescent and adult patients with severe HES. The HES trial met its

The post GSK’s mepolizumab succeeds in phase 3 trial in hypereosinophilic syndrome appeared first on Pharmaceutical Business review.


Finch Therapeutics, Takeda expand collaboration to develop microbiome therapeutics

Under the terms of the expanded agreement, Finch and Takeda will utilize Finch’s platform to target Crohn’s disease, a form of inflammatory bowel disease. Finch’s Human-First Discovery platform

The post Finch Therapeutics, Takeda expand collaboration to develop microbiome therapeutics appeared first on Pharmaceutical Business review.


RDD Pharma signs LOI to acquire Naia Rare Diseases

Closing of the transaction is anticipated to occur after the consummation of the proposed merger of RDD and Innovate Biopharmaceuticals, Inc. (Nasdaq: INNT) which will form a combined

The post RDD Pharma signs LOI to acquire Naia Rare Diseases appeared first on Pharmaceutical Business review.


Merck to acquire Calporta Therapeutics for $576m

The transaction includes an upfront payment and contingent milestone payments. Calporta is involved in the development of selective small-molecule agonists to TRPML1 (transient receptor potential cation channel, mucolipin

The post Merck to acquire Calporta Therapeutics for $576m appeared first on Pharmaceutical Business review.


Lupin to sell its stake in Kyowa to Unison for $526m

Founded in 1998, Unison is an independent private equity firm investing in the healthcare sector across Japan, Korea and Singapore, with an emphasis on the pharmaceutical sector. Unison

The post Lupin to sell its stake in Kyowa to Unison for $526m appeared first on Pharmaceutical Business review.


Mylan, Pfizer announce Viatris as new company name

Deriving its name from Latin, Viatris embodies the new company’s goal of providing a path—“VIA”—to three—“TRIS”—core goals: expanding access to medicines, leading by innovating to meet patient needs,

The post Mylan, Pfizer announce Viatris as new company name appeared first on Pharmaceutical Business review.


X4 Pharmaceuticals receives breakthrough therapy designation from FDA for Mavorixafor to treat WHIM Syndrome

Mavorixafor is a potential first-in-class, once-daily, oral, small molecule antagonist of chemokine receptor CXCR4, and is currently being investigated in a pivotal Phase 3 global clinical trial, 4WHIM,

The post X4 Pharmaceuticals receives breakthrough therapy designation from FDA for Mavorixafor to treat WHIM Syndrome appeared first on Pharmaceutical Business review.


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

American College of Allergy, Asthma & Immunology, Nov. 7-11
The 2019 Annual Meeting of the American College of Allergy, Asthma & Immunology The annual meeting of the American College of Allergy, Asthma & Immunology was held from Nov. 7 to 11 in Houston and attracted approximately 3,500 participants...
FDA Panel: Expand Use of Fish Oil Drug Vascepa
FRIDAY, Nov. 15, 2019 -- Approved use of the prescription-strength fish oil drug Vascepa should be widened to include more patients at risk for heart attack and stroke, a U.S. Food and Drug Administration advisory panel recommended Thursday. Vascepa...
CDC: Number of Vaping-Linked Lung Illnesses Up to 2,172
FRIDAY, Nov. 15, 2019 -- The number of Americans stricken with a severe respiratory illness tied to vaping has now reached 2,172, the U.S. Centers for Disease Control and Prevention reported Thursday. That is a rise from the 2,051 case total from a...
FDA Sends Warning Letter About OTC Drugs to Dollar Tree
FRIDAY, Nov. 15, 2019 -- Dollar Tree has been sent a warning letter for selling over-the-counter (OTC) drugs made by foreign companies with serious, multiple violations of federal manufacturing laws, the U.S. Food and Drug Administration says. The...
About 2.7 Million ED Visits Reported for Sports Injuries in 2010 to 2016
FRIDAY, Nov. 15, 2019 -- About 2.7 million emergency department visits for sports injuries occurred during 2010 to 2016, according to a study published online Nov. 15 in the National Health Statistics Reports, a publication of the U.S. Centers for...
Risk for Disability Worsening Increased for MS With Comorbid Depression
FRIDAY, Nov. 15, 2019 -- The risk for disability worsening is increased for individuals with multiple sclerosis (MS) and comorbid depression, according to a study published online Nov. 8 in Neurology. Stefanie Binzer, M.D., Ph.D., from the...
Some Progress Made in Slowing Antibiotic Resistance-Linked Deaths
FRIDAY, Nov. 15, 2019 -- Progress has been made in slowing antibiotic resistance-associated deaths, but more than 2.8 million antibiotic-resistant infections occur each year in the United States, according to a report published by the U.S. Centers...
Higher Waist Circumference Tied to Increased Risk for Dementia
FRIDAY, Nov. 15, 2019 -- Abdominal obesity is associated with significantly increased risk of dementia, even after adjustment for general obesity, according to a study published online Nov. 5 in Obesity. Geum Joon Cho, M.D., Ph.D., from the Korea...
12 Cases of Vaping-Related Lung Injury Described in One Hospital
FRIDAY, Nov. 15, 2019 -- Twelve cases of electronic cigarette, or vaping, product use-associated lung injury (EVALI) from a single institution have been described in a case series published online Nov. 8 in The Lancet Respiratory Medicine. Aleksandr...
AHA: Many With Atherosclerotic CVD Not Meeting LDL-C Goals
FRIDAY, Nov. 15, 2019 -- A high proportion of patients with atherosclerotic cardiovascular disease (ASCVD) do not achieve recommended low-density lipoprotein cholesterol (LDL-C) goals, according to a study presented at the annual meeting of the...
Childhood Episode of Pancreatitis May Up Risk for Diabetes Later
FRIDAY, Nov. 15, 2019 -- A history of a clinically resolved, single event of acute pancreatitis in childhood is associated with an increased risk for diabetes during young adulthood, according to a study published online Nov. 6 in Diabetes...
Too Few Medicare Beneficiaries With Diabetes Getting Eye Exams
FRIDAY, Nov. 15, 2019 -- Nationwide, about half of Medicare fee-for-service beneficiaries with diabetes had eye exams in 2017, according to research published in the Nov. 15 issue of the U.S. Centers for Disease Control and Prevention Morbidity and...
Pembrolizumab Prolongs Survival in Advanced Head, Neck Cancer
THURSDAY, Nov. 14, 2019 -- The checkpoint inhibitor pembrolizumab prolongs survival in patients with certain head and neck cancers, according to a phase 3 study published online Oct. 31 in The Lancet. Barbara Burtness, M.D., from the Yale University...
Treatment Response Rates High for Seniors With Hep C Infection
FRIDAY, Nov. 15, 2019 -- For patients with chronic hepatitis C infection, sustained viral response (SVR) rates are similar for those aged 65 years and older and those younger than 65, according to a study published online Oct. 24 in the Journal of...
First Ebola Vaccine Approved by European Commission
THURSDAY, Nov. 14, 2019 -- The world's first Ebola vaccine has been approved by the European Commission, and it was quickly prequalified by the World Health Organization. The Ervebo vaccine is made by Merck and is being used in a "compassionate use"...
WHO to Test, Approve Generic Insulin
THURSDAY, Nov. 14, 2019 -- Testing and approval of generic insulin will be conducted by the World Health Organization in an attempt to combat rising prices and shortages of the drug. About half of the 80 million people with diabetes worldwide who...
Survey of U.S. Registered Nurses Points to Worsening Shortages
THURSDAY, Nov. 14, 2019 -- The 2019 AMN Healthcare Survey of Registered Nurses raises concerns about the outlook for the nursing profession in the United States. Cole Edmonson, D.N.P., R.N., chief clinical officer of AMN Healthcare, and colleagues...
Minimum Age to Buy Tobacco, E-Cigarettes Raised in NY State
THURSDAY, Nov. 14, 2019 -- The minimum age to buy tobacco and electronic cigarette products in New York State is now 21. The new law took effect on Wednesday and officials said that state police and the Department of Health will conduct undercover...
American Society of Nephrology, Nov. 7-10
The Annual Meeting of the American Society of Nephrology, Kidney Week 2019 The annual meeting of the American Society of Nephrology was held from Nov. 7 to 10 in Washington, D.C., and attracted approximately 13,000 participants from around the...
Secondary Surgical Cytoreduction Not Superior in Ovarian Cancer
THURSDAY, Nov. 14, 2019 -- For patients with platinum-sensitive recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy does not result in longer overall survival than chemotherapy alone, according to a study published in...
Surgery for Congenital Heart Disease Tied to Kidney Disease
THURSDAY, Nov. 14, 2019 -- The risk for mortality and end-stage kidney disease (ESKD) is high in children who undergo surgical repair for congenital heart disease compared with the general population, according to a study published in the October...
Four Studies Look at Global Burden of Digestive Diseases
THURSDAY, Nov. 14, 2019 -- Global burdens of colorectal cancer, pancreatic cancer, inflammatory bowel disease (IBD), and stomach cancer increased from 1990 to 2017, according to four studies published online Oct. 21 in The Lancet Gastroenterology...
AHA: Risk for Death Cuts Benefit of Oral Anticoagulants for A-Fib
THURSDAY, Nov. 14, 2019 -- For older patients with atrial fibrillation, the competing risks for death reduce the net clinical benefit (NCB) of oral anticoagulation, according to a study published online Nov. 11 in Circulation: Cardiovascular Quality...
AHA: Vitamin D, Omega-3 Do Not Cut Heart Failure Hospitalization
THURSDAY, Nov. 14, 2019 -- Neither vitamin D nor marine omega-3 (n-3) fatty acid supplementation significantly reduces the rate of first heart failure hospitalization, according to a research letter published online Nov. 11 in Circulation to...
1999 to 2016 Saw Increase in U.S. Adults Trying to Lose Weight
THURSDAY, Nov. 14, 2019 -- From 1999 to 2016, there were trends for increases in measured body mass index (BMI) and weight among adults in the United States, and there was an increase in the proportion of adults attempting to lose weight, according...
Illiteracy Tied to Dementia in Older Adults With Low Education
THURSDAY, Nov. 14, 2019 -- Illiteracy is associated with prevalent and incident dementia, but not with the rate of cognitive decline, among older adults with low education, according to a study published online Nov. 13 in Neurology. Miguel Arce...
Tobacco Cessation Programs May Up Quit Rates in Cancer Patients
THURSDAY, Nov. 14, 2019 -- Enrolling actively-smoking oncology patients into a comprehensive tobacco cessation program may help patients sustain long-term abstinence from smoking and improve their cancer treatment outcomes, according to a study...
Higher Skeletal Muscle Mass May Lower Long-Term Risk for CVD
THURSDAY, Nov. 14, 2019 -- Skeletal muscle mass (SMM) is inversely associated with the incidence of cardiovascular disease (CVD) among middle-aged and older adults, according to a study published online Nov. 11 in the Journal of Epidemiology &...
Few Women With Chronic Health Issues Use Reliable Birth Control
THURSDAY, Nov. 14, 2019 -- One in three women of reproductive age have a chronic condition that could compromise their health or lead to adverse outcomes during pregnancy, yet few use the most effective forms of contraception, according to a study...
Cannabis Use Disorder Up With Recreational Pot Legalization
WEDNESDAY, Nov. 13, 2019 -- Cannabis use disorder (CUD) has increased among adolescents and adults (≥26 years) after recreational marijuana legalization (RML) enactment, according to a study published online Nov. 13 in JAMA Psychiatry. Magdalena...
Health Groups Urge President to Ban All Flavored E-Cigarettes
WEDNESDAY, Nov. 13, 2019 -- An ad campaign urging U.S. President Donald Trump to follow through on a commitment to ban all flavored electronic cigarettes, including mint and menthol, has been launched by a number of public health groups. "This...
Smartwatch App Shows Promise for Identifying Atrial Fibrillation
WEDNESDAY, Nov. 13, 2019 -- For participants without atrial fibrillation, use of a smartwatch application (app) can identify irregular pulse, which may indicate atrial fibrillation with high positive predictive value, according to a study published...
Invasive Melanoma Incidence Decreasing in Teens, Young Adults
WEDNESDAY, Nov. 13, 2019 -- Melanoma incidence seems to be decreasing in adolescents and young adults, according to a study published online Nov. 13 in JAMA Dermatology. Kelly G. Paulson, M.D., Ph.D., from the Fred Hutchinson Cancer Research Center...
Imaging Rates Continue to Rise Despite Efforts to Reduce
WEDNESDAY, Nov. 13, 2019 -- Despite initiatives to reduce the use of medical imaging, rates continue to rise in both the United States and Ontario, Canada, according to a study recently published in the Journal of the American Medical...
AHA: Intensive BP Control May Increase Life Expectancy
WEDNESDAY, Nov. 13, 2019 -- Intensive blood pressure control results in an increase in life expectancy, and new hypertension guidelines may be cost-effective only for certain patients, according to two studies presented at the annual meeting of the...
More Hospital Days Seen With Antipsychotic Use in Alzheimer Disease
WEDNESDAY, Nov. 13, 2019 -- Alzheimer disease patients who initiate treatment with antipsychotic medications spend more days hospitalized than those who do not initiate antipsychotics, according to a study recently published in the Journal of...
Early Childhood High BMI Tied to Maternal Prepregnancy Factors
WEDNESDAY, Nov. 13, 2019 -- A child's high and increasing body mass index (BMI) between ages 2 and 6 years is strongly associated with maternal prepregnancy weight, according to a study published online Nov. 5 in Pediatric Obesity. Xinhui Wang,...
Physical Activity After Cancer Diagnosis Improves Survival
WEDNESDAY, Nov. 13, 2019 -- At least 150 minutes per week of moderate-intensity physical activity is associated with lower all-cause mortality among postmenopausal breast cancer patients, regardless of their levels of physical activity before...
ASN: Encephalopathy Up in CKD Patients on Higher-Dose Baclofen
WEDNESDAY, Nov. 13, 2019 -- The incidence of encephalopathy is increased with prescription of higher versus lower doses of baclofen among older patients with chronic kidney disease (CKD), according to a study published online Nov. 9 in the Journal...
ACR: Few Serious Infections Seen in Infants Exposed to non-TNFis, Tofacitinib
WEDNESDAY, Nov. 13, 2019 -- For offspring of mothers with inflammatory disease, those exposed to tofacitinib or non-tumor necrosis factor inhibitor (TNFi) biologics in utero have few serious infections, according to a study presented at the annual...

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