• Filter By:
• Specialty
• Source
• Condition
• Cancer
• Infectious Disease
• Drug
• Training
• Management
• Procedure
• Therapy
• Vaccine
• Nutrition
• Country

Janssen Announces U.S. FDA Approval of PONVORY ™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions
TITUSVILLE, N.J. – (March 19, 2021) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by ove...
Source: Johnson and Johnson - March 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Sodium –Glucose Cotransporter-2 Inhibitors and Heart Failure Prevention in Type 2 Diabetes
In 2008, the European Medicines Agency and US Food and Drug Administration (FDA) issued industry guidance stating that all future novel glucose-lowering agent trials must undergo routine cardiovascular risk evaluation either before approval or as a post-marketing commitment.1 This mandated that all cardiovascular endpoint committees prospectively adjudicate all major adverse cardiovascular events, including cardiovascular death, non-fatal MI and stroke, occurring across Phase II and III diabetes trials.
Source: Radcliffe Cardiology - November 4, 2019 Category: Cardiology Authors: mehul Source Type: research

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System
Conclusion: Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory and to reduce the burden of medication errors and inappropriate prescription. Introduction Oral anticoagulant therapy is widely used for the prevention of stroke and systemic embolism in patients with atrial fibrillation, or for the prevention and treatment of deep vein thrombosis and pulmonary embolism (Raj et al., 1994; Monaco et al., 2017). Oral anticoagulants can be di...
Source: Frontiers in Pharmacology - April 29, 2019 Category: Drugs & Pharmacology Source Type: research

Protocol of the Febuxostat versus Allopurinol Streamlined Trial (FAST): a large prospective, randomised, open, blinded endpoint study comparing the cardiovascular safety of allopurinol and febuxostat in the management of symptomatic hyperuricaemia
Introduction Gout affects 2.5% of the UK's adult population and is now the most common type of inflammatory arthritis. The long-term management of gout requires reduction of serum urate levels and this is most often achieved with use of xanthine oxidase inhibitors, such as allopurinol. Febuxostat is the first new xanthine oxidase inhibitor since allopurinol and was licensed for use in 2008. The European Medicines Agency requested a postlicensing cardiovascular safety study of febuxostat versus allopurinol, which has been named the Febuxostat versus Allopurinol Streamlined trial (FAST). Methods and analysis FAST is a cardi...
Source: BMJ Open - July 10, 2014 Category: Journals (General) Authors: MacDonald, T. M., Ford, I., Nuki, G., Mackenzie, I. S., De Caterina, R., Findlay, E., Hallas, J., Hawkey, C. J., Ralston, S., Walters, M., Webster, J., McMurray, J., Perez Ruiz, F., Jennings, C. G., MacDonald, Ford, Nuki, Mackenzie, Hallas, Webster, Walte Tags: Open access, Cardiovascular medicine, Research methods Protocol Source Type: research

Families face battle with GSK over dangerous diabetes drug
Exclusive: Pharmaceutical giant resists claims despite settlement with victims in USThousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US.The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.A scientist with the Food and Drug Administration estimated that Avandia co...
Source: Guardian Unlimited Science - January 29, 2013 Category: Science Authors: Sarah Boseley Tags: The Guardian United States World news Pharmaceuticals industry Medical research Legal aid Law UK news Diabetes GlaxoSmithKline Business Source Type: news