A recent Phase 3 clinical trial found apremilast safe and effective for treating patients with active psoriatic arthritis and skin symptoms who found conventional and biologic DMARDs ineffective…
U.S. & EU Regulators Urge Indian Drug Companies to Step Up Standards
MUMBAI (Reuters)—U.S. and EU drug regulators called upon India’s pharmaceutical sector on Tuesday to step up efforts to improve manufacturing standards and ensure the reliability of data if it is to maintain its dominance in the generic drugs industry. India’s $15 billion pharmaceutical industry, an increasingly important global supplier of cheaper generic medicines, has been…
Amgen, UCB Say Osteoporosis Drug Meets Main Goal in Late-Stage Trial
(Reuters)—Amgen Inc. and Belgium-based UCB SA said on Monday that their osteoporosis drug met all the primary endpoints by reducing the incidence of new vertebral fracture in postmenopausal women with osteoporosis in a late-stage study. The topline results, from a Fracture study in postmenopausal women with osteoporosis (FRAME), showed that the drug romosozumab met a…
Scientists Find How ‘Superbugs’ Build Their Defenses
LONDON (Reuters)—Scientists in Britain have found how drug-resistant bacteria build and maintain a defensive wall—a discovery that paves the way for the development of new drugs to break through the barrier and kill the often deadly “superbugs.” In recent decades, bacteria resistant to multiple drugs, such as methicillin-resistant Staphylococcus aureus (MRSA) or Clostridium difficile, have…
Pfizer Unit to Pay $784.6 Million in Medicaid Rebate Settlement
(Reuters)—Pfizer Inc. said its Wyeth unit has agreed to pay $784.6 million to settle cases related to the calculation of Medicaid rebates for a gastric drug between 2001 and 2006. The claims alleged that Wyeth’s calculation of rebates for its proton pump inhibitor Protonix (pantoprazole) violated the Federal Civil False Claims Act and other laws…
FDA Update: Infliximab Biosimilar Garners Support & Fibromyalgia Drug Receives Fast Track
Recently, an FDA committee announced support for the approval of CT-P13, an infliximab biosimilar. The FDA has also fast tracked the development of a fibromyalgia treatment designed for multiple symptoms…
Rheumatology Drug Updates: Biosimilars Seek Regulatory Approval in the U.S., Europe; Methotrexate Underused
Biosimilars Receive Positive News On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 If approved, Benepali can be used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis and plaque psoriasis….
Tofacitinib Decreases Inflammation in Early RA
A recent study used MRI to show that tofacitinib reduces inflammation and inhibition of the progression of structural damage in adults with early RA…
No Cause Found Yet for Botched French Drug Trial
PARIS (Reuters)—An initial report into a drug trial in northwestern France that left one person dead and five others hospitalized last month did not identify the exact cause, French Health Minister Marisol Touraine said on Thursday. Touraine told a news conference that the condition of the five people who were hospitalized was improving and that…
Bowing to Pressure, FDA to Reform Painkiller Approval Process
WASHINGTON (Reuters)—Bowing to pressure from lawmakers, Dr. Robert Califf, President Barack Obama’s nominee to lead the U.S. Food and Drug Administration (FDA), said on Thursday the agency would reform its process for approving opioid painkillers. Last month, Sen. Edward Markey (D-Ma.) placed a hold on Califf’s nomination, preventing it from being voted on by the…
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