New research indicates that vaccination for the herpes zoster virus in patients with rheumatoid arthritis starting tofacitinib appears to be both safe and useful. Rheumatologists may want to check the patient’s pre-existing immunity status prior to administering the vaccine…
WASHINGTON (Reuters)—The U.S. Senate on Monday moved closer to confirming Dr. Robert Califf to lead the U.S. Food and Drug Administration, overriding opposition from several senators who had sought to block a vote on the issue. In a procedural move designed to prevent the opponents from blocking the confirmation indefinitely, the Senate voted 80 to…
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…
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…
(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…
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…
(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…
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…
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….
A recent study used MRI to show that tofacitinib reduces inflammation and inhibition of the progression of structural damage in adults with early RA…