Clinical drug trial costs 'surprisingly low,' Johns Hopkins researchers find
Contrary to past drug company pronouncements, the cost of clinical trials makes up a small fraction of pharmaceutical drug development costs, a new study concludes.
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IVANTIS, INC.: Announces Groundbreaking 3 Year Results from FDA Clinical Trial; First Device in Minimally Invasive Glaucoma Surgical (MIGS) Category to Demonstrate Significant Long Term Reduction of Severe Major Surgeries for Glaucoma Patients
First study of any kind showing a MIGS device achieving a statistically significant reduction in secondary incisional surgery; over 70% of patients remain free of medications
FDA moves to reduce risks associated with surgical staplers and implantable stables
The Medical Device Safety Action plan outlines the FDA’s mission to protect public health in a more timely and effective way.
New campaign seeks to remove opioids from the home
The Food and Drug Administration is looking to women aged 35-64 to “Remove the Risk” of opioids in the household.
U.S. FOOD AND DRUG ADMINISTRATION: First FDA-approved vaccine for the prevention of dengue disease in endemic regions
The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
'Stop doing these analyses,' Mercatus Center researcher says ahead of FDA benefit-risk public meeting
The U.S. Food and Drug administration's public meeting in May about the agency's human drug lifecycle benefit-risk activities has already attracted a recommendation from a regulatory and policy researcher: “stop doing these analyses.”
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves device to help increase access to more lungs for transplant
The U.S. Food and Drug Administration approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for pediatric patients with lupus
The U.S. Food and Drug Administration approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) – often referred to as simply “lupus”
NEUROSIGMA, INC.: Announces FDA Clearance of Monarch eTNS System as First Non-Drug Treatment for Pediatric ADHD
NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders announced that its Monarch® eTNS® System (Monarch) received FDA clearance as a non-drug treatment for attention deficit hyperactivity disorder (ADHD).
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ABBVIE: Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis
Approval based on clinical trials showing people treated with SKYRIZI™ (risankizumab-rzaa) every 12 weeks - four doses a year after two initial doses - achieved high levels of durable skin clearance at 16 weeks and maintained this response at one year[1-3]
Out-of-pocket drug costs a key voter concern, new poll finds
Lowering out-of-pocket costs for prescription drugs is among American voters’ top health concerns, a new poll by released by a drug company trade association concludes.
BOSTON SCIENTIFIC CORPORATION: Receives FDA Approval for LOTUS Edge™ Aortic Valve System
Transcatheter Aortic Valve Replacement Technology for Patients with Severe Aortic Stenosis Designed to Minimize Paravalvular Leakage, Offer Controlled Delivery and Repositionability Post Deployment
ALIVECOR: FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device
KardiaMobile® Now The Only Personal ECG to Detect The Three Most Common Heart Arrhythmias
Surgical mesh for transvaginal repair to be taken off the market
Manufactures of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) must stop selling their product after an order from the Food and Drug Administration.
FDA seeks public input on participation in rare-disease studies
The Food and Drug Administration is set to hold a public meeting on April 29 regarding “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.”
LONGHORN VACCINES AND DIAGNOSTICS LLC: PrimeStore® MTM opens Sputum-free Molecular Screening for M. tuberculosis Infection
South Africa pilot study demonstrates new broad approach to identifying M. tuberculosis infected patients for further clinical investigation and treatment
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VETOQUINOL USA: Launches Flexprofen™
Generic carprofen chewable tablet developed to treat osteoarthritis symptoms in dogs
MALLINCKRODT PLC: Mallinckrodt Lupus Phase 4 Clinical Study for Acthar® Gel (Repository Corticotropin Injection) Completes Enrollment in Difficult-to-Manage Population
Company continues focus on evidence expansion, potential utility of Acthar Gel in appropriate, underserved patients
BARONOVA, INC.: Announces FDA Approval of the TransPyloric Shuttle® (TPS®) Device
A First-in-Class, Non-Surgical Solution for Obesity Approved for One-Year of Device Treatment, Offering Patients Potentially More Durable Weight Loss and Health Benefits
ANDERSON ADVANCED INGREDIENTS: Commends the FDA's updated allulose guidelines
Anderson Advanced Ingredients® commends the most recent draft guidance by the U.S. Food and Drug Administration (FDA) titled "The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels".