(Reuters)—President Barack Obama’s nominee to head the U.S. Food and Drug Administration defended his ties to the pharmaceutical industry on Tuesday during a Senate committee hearing that included questions on soaring drug prices. Presidential candidate Bernie Sanders was among the Democrats who grilled Dr. Robert Califf (64), who joined the FDA in January as a…
Rheumatology Drug Updates on Brentuximab Vedotin, Tofacitinib Citrate
Brentuximab Vedotin Enters Phase 2 Trials Brentuximab vedotin (Adcetris), an antibody-drug conjugate (ADC) directed at CD30, is currently entering Phase 2 clinical trials for treating systemic lupus erythematosus (SLE).1 The ADC encompasses an anti-CD30 monoclonal antibody, which is attached by a protease-cleavable linker to a microtubule-disrupting agent, known as monomethyl auristatin E (MMAE). The ADC…
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…
Tofacitinib on Hold for Psoriasis, Plus Anti-TNFs Top FDA List for Adverse Events
The FDA is asking for more safety analysis before approving tofacitinib to treat psoriasis. Also, adalimumab and etanercept received the greatest number of adverse and serious adverse events reported to the FDA in 2014…
FDA Reviewers Question Safety of AstraZeneca’s Gout Drug
(Reuters)—The U.S. Food and Drug Administration staff reviewers have raised concerns about kidney- and heart-related side effects noted in trials on AstraZeneca Plc’s gout treatment, especially at higher doses. FDA reviewers, in a preliminary review published on Wednesday, expressed concerns over higher death rates related to the side effects in patients who took the drug,…
FDA Declines to Expand Approval of Pfizer Arthritis Drug Xeljanz
(Reuters)—U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz (tofacitinib) to treat moderate to severe cases of plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must be addressed in order…
FDA Issues Stronger Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Warning
The U.S. Food and Drug Administration (FDA) has toughened the existing warnings for nonsteroidal anti-inflammatory drugs (NSAIDs) due to their stroke and myocardial infarction (MI) risk increase.1 Due to a continual review of these products, FDA is requiring label updates for all prescription NSAIDs. Over-the-counter (OTC) NSAIDs already list the increased risk of MI and…
Novartis Biosimilar Takes Aim at Amgen’s Enbrel
ZURICH (Reuters)—The U.S. Food and Drug Administration has accepted Novartis unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s blockbuster anti-TNF drug Enbrel, the Swiss drugmaker said on Friday. Enbrel, or etanercept as the drug is known generically, is a big prize since it was the world’s fifth-biggest selling medicine in 2014…
Rituximab for RA Is Safe Long Term, Plus Oxycodone Update
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.
FDA Issues Warning for Joint Pain from Diabetes Drugs
Severe and disabling joint pain has been connected to the use of dipeptidyl peptidase-4 inhibitors and combination therapies for diabetes, prompting a new FDA warning…
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