An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…
U.S. Sen. Markey Places Hold on Obama’s Nominee to Lead FDA
(Reuters)—U.S. Sen. Edward Markey (D-Mass.) said on Monday he has placed a hold on President Barack Obama’s nominee to head the U.S. Food and Drug Administration until the agency agrees to reform its process for approving opioid painkillers. Markey wants future opioid-approval matters to be reviewed by an FDA advisory committee, and believes the committee…
FDA Approves New Drugs for Pain
FDA Updates Belbuca, buccal-administered buprenorphine, has received U.S. Food and Drug Administration (FDA) approval for treating severe chronic pain.1 The dosage form is a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. It’s expected to be commercially available in the first quarter of 2016. Seven dosage strengths…
Drug Approvals Top 2014 High, but R&D Returns Still Struggle
LONDON (Reuters)—The number of new drugs approved in the U.S. this year has already topped last year’s 18-year high, yet large pharmaceutical companies are still struggling to get a decent return on their research dollars. In fact, returns on research and development (R&D) spending by the world’s top drug makers have fallen to just 4.2%,…
FDA Approves Drug to Counter Opioid ODs
The FDA recently approved a form of naloxone hydrochloride in a nasal spray that will help counter opioid overdoses. The FDA also approved an ibuprofen injection as an adjunct to opioids for use in children 6 months and older…
Amgen Files for U.S. Approval of Biosimilar
(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…
Drug Makers Inconsistent in Sharing Clinical Trial Data
(Reuters Health)—Drug companies are inconsistent about disclosing data related to clinical trials of new medicines, a new report says. Researchers examined publicly available data on clinical trials for 15 new medicines from 10 companies that were cleared for sale by the U.S. Food and Drug Administration in 2012. Two of the companies disclosed all trials…
Obama Nominee to Lead FDA Defends Drug Industry Ties
(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…
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