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Articles tagged with "FDA"

FDA Warns Mylan Over Quality Concerns at India Facility

Natalie Grover  |  

(Reuters)—The U.S. Food and Drug Administration (FDA) has raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency dated April 3. India-based drug manufacturing facilities have been criticized by the FDA in recent years for violating quality standards, as the agency increases oversight of…

Corbus Pharma Outlines U.S. Approval Path for Scleroderma Drug

Natalie Grover  |  

(Reuters)—The U.S. Food and Drug Administration needs Corbus Pharmaceuticals to show positive data from only one late-stage study on its experimental treatment for scleroderma to support a marketing application, the company said. Corbus said on Wednesday it expects to start the study on 270 patients in the fourth quarter and that it was in talks…

Trump Nominee to Lead FDA Probed on Ties to Pharmacy Industry

Reuters Staff  |  

(Reuters)—President Donald Trump’s nominee to lead the U.S. Food and Drug Administration, Dr. Scott Gottlieb, was questioned about his ties to the pharmaceutical industry by Democrats on a key Senate committee on Wednesday ahead of a vote on whether to advance his nomination for a vote by the full Senate. Gottlieb, 44, is a former…

Trump Chooses Gottlieb to Run FDA; Pharma Breathes Sigh of Relief

Toni Clarke  |  

WASHINGTON (Reuters)—U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, the White House said on Friday. If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to dramatically cut regulations governing…

FDA Approves Valeant’s Drug to Treat Plaque Psoriasis

Reuters Staff  |  

(Reuters)—The U.S. Food and Drug Administration has approved Valeant Pharmaceuticals International Inc.’s brodalumab (Siliq) to treat adults with moderate to severe plaque psoriasis. Brodalumab is administered as an injection. Brodalumab is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond, or have stopped responding to other systemic therapies,…

Rheumatology Drug Updates: Efficacy & Safety of Guselkumab, Plus FX006 for Knee OA

Kelly April Tyrrell  |  

Guselkumab Improves Active Psoriatic Arthritis New research has revealed that patients with active psoriatic arthritis (PsA) and ≥3% body area of plaque psoriasis benefit from treatment with a human monoclonal antibody known as guselkumab (GUS). GUS is specific for the p19 subunit of interleukin 23 (IL-23). Patients in the Phase 2 clinical trial experienced significant…

Biosimilars to Raise Unique Questions

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Rheumatologists are accustomed to educating patients about medications, but biologic medications—and now biosimilars—require some additional time and discussion. “Biologics are inherently more complex [than other medications], and there are multiple issues to consider before initiating treatment,” says K. “Kwas” Huston, MD, The Center for Rheumatic Disease, Kansas City, Mo. The first FDA-approved biosimilar to become…