A new formulation of oxycodone in 10 and 15 mg doses is being reviewed by the FDA for treating pain…
Baricitinib Approval Stalls; Plus No REMS for Erythropoiesis-Stimulating Agents
The FDA has declined to approve baricitinib to treat rheumatoid arthritis, citing the need for more data on dosing and safety…
Biosimilar Drugs Raise Questions around Treatment Efficacy, Quality, Safety
WASHINGTON, D.C.—Challenges abound for the manufacturing of biosimilar drugs—from their sheer size compared with small molecule drugs to the unknowable proprietary aspects of the originator drugs—an expert said at the 2016 ACR/ARHP Annual Meeting in a session titled Immunology Update: Biologic Agents: From Nature to Protein Engineering to Biosimilars. Above all, because biosimilars are copies…
Nevada Rheumatologists Take on Biologic and Biosimilar Substitution
On March 22, 2017, Ewa Olech, MD, testified at a hearing before the Nevada State Assembly to voice support for A.B. 245, a bill governing biologic medications and biosimilar substitution in that state. She spoke on behalf of the Rheumatology Association of Nevada (RAN), as its president and founder. The bill establishes guidelines regarding biosimilars and requires…
U.S. FDA Declines to Approve Eli Lilly & Incyte Arthritis Drug
WASHINGTON (Reuters) – The U.S. Food and Drug Administration (FDA) on Friday declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co and partner Incyte Corp, the companies said on Friday. The FDA indicated that additional clinical data was needed to determine the most appropriate doses of the drug, baricitinib…
Insufficient Evidence Regarding Osteoporosis Medications in Kidney Patients
NEW YORK (Reuters Health)—There are insufficient data to make evidence-based decisions regarding the benefits and harms of osteoporosis medications in patients with chronic kidney disease (CKD), according to a systematic review and meta-analysis. “We found low to moderate evidence for the effects of some but not all of the medications, and the evidence was limited…
Ustekinumab Has Longer Efficacy Duration than TNFIs for Plaque Psoriasis
When compared with TNFIs, ustekinumab demonstrated a longer drug survival rate in patients with severe plaque psoriasis…
When Starting Biologics for RA, Disease Severity Predicts Likelihood of Remission
NEW YORK (Reuters Health)—After starting biologic therapy for rheumatoid arthritis (RA), patients with higher disease activity at baseline achieved greater improvements in measures of disease activity than those with lower levels of disease, but they were less likely to achieve remission or even low disease activity, according to a new real world analysis of registry data….
As Biosimilars Hit, EU Pharma Warns against Blanket Prescribing
LONDON (Reuters)—European drugmakers, faced with increasing competition from cut-price copies of complex biotech drugs, cautioned doctors on Thursday to take care when switching patients from an established product to biosimilar version. The complex nature of biological medicines, which are made inside living cells, means copies can never be exactly the same as the original. But…
Brodalumab Approved for Plaque Psoriasis
Brodalumab has received FDA approval for treating plaque psoriasis in adults, with a Boxed Warning against prescribing it for patients with a history of suicidal thoughts or behavior…
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