(Reuters)—Amgen Inc. on Wednesday said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie’s Humira (adalimumab), the world’s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira in late stage clinical trials…
Search results for: generic
Oxycodone Capsules Put on Hold; Clinical Trials for Lupus Nephritis & SLE Therapies
Due to a lawsuit, the FDA has issued only tentative approval for an extended-release oxycodone capsule. Obinutuzumab is in clinical trials for lupus nephritis, and subcutaneous belimumab is being tested for SLE…
Pfizer to Buy Allergan in $160 Billion Deal
NEW YORK (Reuters)—Pfizer Inc. on Monday said it would buy Botox maker Allergan Plc. in a deal worth $160 billion to slash its U.S. tax bill, rekindling a fierce political debate over the financial maneuver. The acquisition, which would shift Pfizer’s headquarters to Ireland, would be the biggest-ever tax inversion. The news prompted Democratic presidential…
FDA Approves 2 Pain Drugs & New Gout Treatment on Road to Approval
The FDA has approved two drugs designed to manage pain: buprenorphine for chronic pain and meloxicam capsules for OA pain. Lesurinad is also closer to FDA approval for treating gout…
U.S. Drug Benefit Managers Clamp Down on Specialty Pharmacies
NEW YORK/LOS ANGELES (Reuters)—In recent days, the largest U.S. managers of private prescription drug benefits have cut off at least eight pharmacies that work closely with drugmakers, intensifying scrutiny of a system that helps inflate drug prices, officials at the benefit managers told Reuters. The terminations come from payers who together manage drug benefits for…
Does Methotrexate Increase Skin Cancer Risk?
A recent study connects the use of immunosuppressant and biologic agents to an increased risk of nonmelanoma skin cancer in patients being treated for RA and IBD…
Rheumatologist Steven S. Overman Reflects on His Last Day of Practice, Future of Specialty
I am a few weeks post-retirement. Having written thank you notes and completed urgent home projects, I swing in a hammock at our currently fire-threatened cabin north of Winthrop, Wash., and reflect. I feel like a young boy while freely flipping pages of a hand-scribed picture book, The Principles of Uncertainty, by Maira Kalman. She…
Expert Q&A: Dr. Michael Lockshin on APS
Michael Lockshin, MD, reminds medical professionals that patients suffering from antiphospholipid syndrome (APS) don’t respond to medications in the same way as patients with other clotting-related diseases. Insufficient evidence exists to determine whether the new wave of anticoagulant medications is safe for use in patients with APS…
RA Drug Tested & FDA Orders Drug-Interaction Studies for Kayexalate
In multiple trials, baricitinib has proved promising for treating RA. Also, the FDA is requiring drug-interaction studies for sodium polystyrene sulfonate…
NIH Director Addresses Gathering of Experts on Autoimmune Diseases
NIH Director Francis Collins, MD, PhD, is working to improve funding for research into new treatments for lupus and RA through the Accelerating Medicines Partnership, a coalition of private and public partners identifying and validating promising biological targets for therapeutics…
- « Previous Page
- 1
- …
- 77
- 78
- 79
- 80
- 81
- …
- 92
- Next Page »