Welcome To Express Scripts Death Panel App
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 27, 2015 Category: Pharmaceuticals Source Type: blogs
Speaking Truth to Scour
Eli Lily's John Lechleiter tells it like it is. And as John Adams said, "Truth is a pesky thing,"
Debunking The Five Big Myths About 'Big Pharma'
If you are a regular reader of politically oriented commentaries on the pharmaceutical industry then you are familiar with, and perhaps even subscribe to, what I call “the Big Five”—myths about this industry that routinely poison debates, obscure genuine problems, and distort policy recommendations on health care. These myths have been all over the public arena again recently, and it’s time to confront them systematically. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 21, 2015 Category: Pharmaceuticals Source Type: blogs
Drug Quality: If you can't measure it, it doesn't count
The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards — a further sign of the agency’s commitment to using quality metrics. The proposed projects, announced Friday, will evaluate batch-to-batch and unit-to-unit variability of companies’ products, capturing data on such quality chemical and physical attributes as tablet weight, assay, content uniformity and dissolution. The data will be used to create a risk-based lifecycle approach that measures quality over every step of the manufacturing process, Peter Pitts, pre...
Source: drugwonks.com Blog - May 14, 2015 Category: Pharmaceuticals Source Type: blogs
Woodcock WebEx on FDA's Office of Pharmacutical Quality
Sign up now for this exclusive question-and-answer webinar with FDA veteran Peter Pitts, President and Co-founder of the Center for Medicine in the Public Interest, as he speaks with Dr. Janet Woodcock, Director of CDER and the driving force behind the formation of the OPQ and Dr. Lawrence Yu, Acting Director of CDER’s Office of Pharmaceutical Science, to help you understand all the changes that will effect you. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 12, 2015 Category: Pharmaceuticals Source Type: blogs
Off Label Communications gets a Buzz Cut
A somewhat slanted viewpoint on off-label communication? You be the judge. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 7, 2015 Category: Pharmaceuticals Source Type: blogs
21st Century Cures and Real World Data
"Calling for the FDA to use this data is pretty revolutionary," said Peter Pitts, a former FDA associate commissioner for external relations and co-founder of the industry-funded Center for Medicine in the Public Interest. "In the past this kind of data was not considered gold standard." (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 30, 2015 Category: Pharmaceuticals Source Type: blogs
21st Century Cures II -- Frank and Earnest
The second iteration of the 21st Century Cures discussion draft comes with some added attractions – most specifically a bi-partisan authorship.As to the actual updated discussion draft, it’s better than its predecessor in many ways, not the least of which is its recognition of the FDA as part of the solution rather than part of the problem. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 29, 2015 Category: Pharmaceuticals Source Type: blogs
The Shocking Truth About Health Insurance Profits
Health plans are raking in record profits under the new health care law. Too bad it's because they are denying breakthrough medicines to cancer patients. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 29, 2015 Category: Pharmaceuticals Source Type: blogs
Biosimilarity, yes. Interchangability, no.
FDA has released three final guidance documents on biosimilars but left for later its regulatory answers on requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for establishing the exclusivity period for pioneer biologics.
FDA will address these issues in a separate draft guidance. The agency does not have an estimated timeline for when the document will be released. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 29, 2015 Category: Pharmaceuticals Source Type: blogs
Janet seeks help. HELP seeks Janet.
Yesterday, CDER Director Dr. Janet Woodcock suggested to the Senate health committee hearing on the Innovation for Healthier Americans Initiative that developing new biomarkers and clinical trial networks, among other strategies, could help improve the drug development process. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 29, 2015 Category: Pharmaceuticals Source Type: blogs
Oz the World Turns
The most famous recent source of bad advice, according to a group of prominent physicians, is Mehmet Oz. His critics recently called on Columbia University to drop the talk show host (who is also a cardiothoracic surgeon) from its medical faculty, slamming him for showing a “disdain for science and evidence-based medicine” and manifesting an “egregious lack of integrity by promoting quack treatments and cures in the interest of personal financial gain.” If a heart attack doesn’t kill you, advice on your Facebook page could. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 27, 2015 Category: Pharmaceuticals Source Type: blogs
Pazdur Speaks!
Love him or hate him (and many people do both), Dr. Richard Pazdur -- director of the FDA's Office of Hematology and Oncology Products-- is the world's most important cancer drug regulator. In an exclusive web interview, Dr. Pazdur tells BioCentury why the agency is racing to approve new cancer drugs. He says new targeted drugs and immunotherapies with unprecedented efficacy are the payoff from 20 years of basic science. He calls for greater patient engagement in drug development, says compassionate access should be improved, and predicts rapid uptake of biosimilars. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 16, 2015 Category: Pharmaceuticals Source Type: blogs
FDA, Opioids, and the Theory of Evolution
The FDA gets it exactly right -- and the key word is "evolving."
FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 1, 2015 Category: Pharmaceuticals Source Type: blogs
Telling the truth about biosimilar nomenclature
In a recent op-ed piece on The Hill’s Congress Blog (“More must be done to improve access to biosimilar drugs,” March 19), Ike Bannon erroneously argues that the use of unique international non-proprietary names (INN) for biosimilar medicines would slow the entry of this new class of drugs into the U.S. market. On the contrary, names that clearly differentiate biosimilars from one another and the original biologic medicine will enhance transparency and build physician confidence in this class of medicine, without which robust utilization is not possible. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - March 26, 2015 Category: Pharmaceuticals Source Type: blogs
In global healthcare policy, no good deed goes unpunished
First Big Pharma was advised to adopt free or differential pricing to developing nations – now the mask is off and it’s all about middle-income countries after all. But wasn’t this entirely predictable, that companies would be criticized for doing what the activists had asked for in the first place? In healthcare, as in life – no good deed goes unpunished. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - March 17, 2015 Category: Pharmaceuticals Source Type: blogs
