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Amid finger-pointing on native ad rules, pharma gears up to do it right

Commentsfiercepharma2016-04-14 11:18 Read   73

A study this week called out a majority of marketers for violating FTC native advertising rules, noting that only one-third use the proper labels.

U.S. docs know scarily little about the FDA process for new drugs

Commentsfiercebiotech2016-04-14 10:04 Read   53

The very people charged with prescribing medicines to patients don’t, as it turns out, know very much at all about how they are approved--and this may be leading them to over-prescribe new drugs.

Bill to rein in drug costs spurs controversy

Commentsbostonglobe2016-04-13 14:48 Read   71

Leslie Wood representing PhRMA, Pharmaceutical Research and Manufacturers of America, testified Monday before the state Legislature’s Joint Committee on Health Care Financing at a public hearing on prescription drug prices.

New myeloma meds work better than the old, but they're far too expensive: Report

Commentsfiercepharma2016-04-13 14:32 Read   86

The Institute for Clinical and Economic Review's new multiple myeloma drug assessment stirred up criticism even before it went public. Now, the not-for-profit group has unveiled its draft report, grading a half-dozen treatment regimens for cost-effectiveness.

Does Biogen selling its hemophilia franchise make sense? Leerink's top analyst says yes

Commentsfiercepharma2016-04-13 10:06 Read   140

As rumors abound that Biogen ($BIIB) is looking to get rid of its $800 million hemophilia assets, some analysts are saying hey, you might as well--and you could see $6 billion for your troubles.

FDA staff question efficacy, safety of Clovis' rociletinib in T790M-positive NSCLC

Commentsfirstwordpharma2016-04-11 10:08 Read   144

 In documents posted to the FDA's website Friday ahead of an advisory panel meeting on April 12, agency staff cast doubt on whether Clovis Oncology's experimental lung cancer drug rociletinib is any more effective than existing treatments.

FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva (obeticholic acid) for the Treatment of Primary Biliary Cirrhosis

Commentsdrugs2016-04-11 09:17 Read   770

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced that the U.S. Food and Drug Administration (FDA)'s Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC).

FDA Flashback: The Top Five New Drug Approvals From 2015

Commentsdrugs2016-04-08 17:23 Read   130

This past year close to 100 new drugs were FDA-approved, so it’s encouraging to look back and see the progress that’s been made as 2015 ends. In fact, more than 40 novel drugs, including a new drug class for patients with high cholesterol, a first-time biosimilar, a life-saving heart failure drug, and a controversial agent to boost women’s libido, all successfully passed through the Agency’s halls.

How Three Companies Have Been Resurrected from Failed Clinical Trials: George Zavoico of JonesTrading RVX, SNSS, THLD, AST, ABEO

Commentsthelifesciencesreport2016-04-08 17:17 Read   90

Data can create or destroy the value of a biotech investment in an instant, but hitting or missing an endpoint doesn't always tell the story.

Intercept surges as FDA review hesitates on endorsing OCA data, but doesn't hate it

Commentsfiercebiotech2016-04-06 11:10 Read   116

FDA staffers reviewing Intercept's data on obeticholic acid (OCA) for rare cases of primary biliary cirrhosis (PBC) noted that the drug clearly hit a key goal in the study after finding the safest dose for patients.

Exclusive: Makers took big price increases on widely used U.S. drugs

Commentsreuters2016-04-05 14:06 Read   87

   Major drug companies took hefty price increases in the U.S., in some cases more than doubling listed charges, for widely used medications over the past five years, a Reuters analysis of proprietary data found.

Survival rates increase for patients with acute liver failure

CommentsHELIO2016-04-05 13:16 Read   102

Both overall survival and transplant-free survival rates increased significantly in adults with acute liver failure, according to data published in the Annals of Internal Medicine.