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Top 5 articles on fibromyalgia highlight pain, fatigue, disability

CommentsHEALIO2016-03-24 14:34 Read   105

Recently published research on fibromyalgia has focused on perceptions about pain and fatigue, and the prevalence of disability among patients with fibromyalgia. Other research highlighted treatment strategies for patients with fibromyalgia and identified subsets of patients who may have varying degrees of symptoms.

Antidepressant use may not increase risk for cardiovascular outcomes

CommentsHealio2016-03-23 13:17 Read   120

Findings from a large observational study indicated no significant associations between selective serotonin reuptake inhibitors and increased risk for arrhythmia, myocardial infarction or stroke/transient ischemic attack in adults with depression.

An Uninformative Truth: The Logic of Amarin’s Off-Label Promotion

CommentsPLOS MEDICINE2016-03-22 14:29 Read   103

 The United States Food and Drug Administration (FDA) generally does not permit pharmaceutical manufacturers to promote their products for non-FDA-approved (“off-label”) indications.

Pharma's doctor payments do pay off, with more money yielding more scripts: ProPublica

Commentscoverage2016-03-22 13:52 Read   174

Doctors deny that speaking fees, free meals, entertainment and other pharma incentives actually change their prescribing habits. They're independent, objective, too high-minded to be influenced by money.

Merck's $20M-plus Harvard deal offers a lesson on the new Economics 101 of preclinical R&D

CommentsMerck2016-03-22 13:16 Read   148

Last fall, the folks behind Harvard's Blavatnik Biomedical Accelerator took a promising preclinical program from the lab of Matthew Shair and essentially posted a "for sale" sign on it--touting its potential for mounting a fresh line of attack on acute myeloid leukemia with a counterintuitive therapeutic strategy ready for the clinic. 

A New Look At The Most Innovative Pharma Companies (And Whether They Are Sustainable) -- Part I

CommentsForbes2016-03-22 12:58 Read   368

Measuring pharma innovation isn’t easy. One typically counts new drugs approved, but that only gauges quantity not quality. Various attempts at assessing quality have been made using such criteria as new modes of action (first-in-class); therapeutic need (orphan drugs); medical value (expert panels); or improvement over the standard of care (breakthrough therapy designations).

Therapy focus – Ovarian cancer field readies for phase III readouts

CommentsEP Vantage2016-03-21 16:14 Read   131

Ovarian cancer specialists are in for a lively few months, with a run of pivotal trial readouts, two or more filings and the outcome of an EU submission for a long-forgotten project – events that could collectively move the field forward.

Study: The FDA's 'breakthrough' program is speeding up cancer approvals

CommentsFriends of Cancer Research2016-03-15 14:50 Read   168

Since the FDA unveiled its breakthrough therapy designation in 2012, cancer drugs brought into the program won approval roughly three months faster than other oncology therapies, according to a new study.

Baxalta makes $1.7bn play for slice of CAR-T market

CommentsBaxalta2016-03-01 15:05 Read   156

Baxalta has made a play for a stake of the emerging CAR-T immunotherapy market with a $1.7bn, three-year alliance with Precision BioSciences.

FDA designated a record number of orphan drugs last year

CommentsSTAT2016-02-16 17:05 Read   148

ophan drugs may target small patient populations, but they are racking up big numbers at the Food and Drug Administration.

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

CommentsFDA2016-01-06 09:22 Read   269

The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina.

The biggest winners--and losers--in the 2015 race for new drug approvals Let's start with the good news.

CommentsJohn Carroll2016-01-05 17:13 Read   292

In 2015, the FDA by its own account approved 45 new drugs, the largest one-year tally since 1996, which wrapped up with a record 53 regulatory OKs.