A recent article from Healio.com reviewed the FDA’s Pregnancy and Lactation Labeling Rule (PLLR) that became effective June 30th.

Secukinumab (Cosentyx) is an anti-IL-17 monoclonal antibody currently approved for use in moderate to severe psoriasis.  It has also been studied in psoriatic arthritis (PsA) and shown to be safe and effective.

Newsweek has reported that the American Board of Internal Medicine has struggled in the last year with increasing criticism over its requirements for maintenance of certification, or MOC.

The American College of Rheumatology and the European League against Rheumatism joined forces to finalize classification criteria for gout, a condition that affects 8.3 million Americans.

The Rheumatology Research Foundation and Rheumatology News report that research projects funded by the National Institutes of Health (NIH) dropped by 52% from 2010 to 2014, while the number funded by private foundations fell by 29% over that period.

Safety reports from literature include long-term safety of rituximab, rituximab-induced neutropenia, tabalumab (Anti-BAFF Mab) results from the ILLUMINATE trial, colchicine toxicity increased in CKD patients, FDA updates and drug labeling changes, and more.

The experimental bone drug, romosozumab, has succeeded in meeting its primary endpoint by showing it was significantly more effective than teriparatide in a 12-month study assessing total hip bone density in postmenopausal women with osteoporosis.  

Reuters reports that Valeant Pharmaceuticals International Inc (a Canadian Pharmaceutical company) is buying rights to AstraZeneca's late-stage experimental psoriasis drug, brodalumab, after it was dropped by codeveloper Amgen Inc in May. Amgen pulled out of the project b

The FDA is under pressure over the recent approval of the "female viagra" pill.  On August 18th, the FDA announced its approval for Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

Most Americans value the prescription products the drug industry produces, but they sure don't like the prices and want the federal government to take action, according to a new survey

Based on potentiallly off-label promotion of blockbuster drugs Aranesp and Enbrel, Amgen has agreed to a $71 million settlement with 48 states and the District of Columbia.

The current JAMA issue examines the process and potential flaws of society clinical practice guidelines -a timely commentary as we await the 2015 ACR RA treatment guidelines first presented at the 2014 ACR meeting in Boston and slated for upcoming publication in Arthritis & Rheumatology

In July 2015, RheumNow published 73 tweets about impactful news, research and teaching points that I feel will have an impact on the rheumatology community. We had a reach (impressions) of 49,900, 63 mentions, and 1277 visits to RheumNow.com to check out what we publish.

Despite Amgen's withdrawal as a co-developer of brodalumab, the anti-IL17A monoclonal antibody, AstraZeneca has announced it will push its plan to develop the drug. Brodalumab is currently in phase III trials for use in psoriasis, psoriatic arthritis and ankylosing spondylitis.

An estimated 250 people have filed lawsuits against Lilly claiming the company failed to warn users of Cymbalta that they may suffer withdrawal symptoms if the drug was stopped abruptly, including suicidal thoughts and electric shock-like sensations.

Can We Do Better than FAERS? Brian Overstreet (of Adverseevents.com) has written on MedPageToday.com about the current state of adverse event reporting.

Placebos are necessary to determine the “true effect” of any medical intervention. As such, they have become the cornerstone of evidence-based medicine, randomized controlled clinical trials and novel drug development.

Several news articles have addressed the rising concern by patients and physicians over the cost of newer drugs. This issue comes to a head as more than 100 oncologists from top cancer hospitals around the U.S.

Several drugs continue to be in short supply, posing significant problems for patients. Foremost on this list is leflunomide (Arava) which is backordered for both 10 mg and 20 mg tablets.  

Leflunomide Shortage

Committees at academic institutions that make decisions on research and clinical trials may be conflicted, as nearly one-third of IRB members have some ties to the pharmaceutical industry.