What Do Jews and Pharma Have In Common?
You knew it would come to this.. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 15, 2016 Category: Pharmaceuticals Source Type: blogs
Opioids Minus the Politics
If you're following the opioids debate and want to cut through the political rhetoric and get right to the meat of the policy debate, here's a conference you should plan on attending the Abuse-Deterrent Formulations Summit. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 9, 2016 Category: Pharmaceuticals Source Type: blogs
Biosimilar Sins of Omission
On Friday, FDA posted briefing documents ahead of the Feb. 9 meeting of its Arthritis Advisory Committee to discuss a BLA from Celltrion Inc. for its CT-P13, a biosimilar of Remicade infliximab from Johnson & Johnson. What's just as interesting is what's not in the package. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 8, 2016 Category: Pharmaceuticals Source Type: blogs
Biosimilar BLA Blah Blah
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 4, 2016 Category: Pharmaceuticals Source Type: blogs
BIO's Value-Based Values
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 4, 2016 Category: Pharmaceuticals Source Type: blogs
Drug Price Reporting Reaches New Low
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 3, 2016 Category: Pharmaceuticals Source Type: blogs
Hoosier Healthcare Hospitality
Sleeping with the Enemy? Hardly. Eli Lilly & Co. has announced an important collaboration with an unlikely bedfellow – their Hoosier neighbor, Anthem. The goal is to help develop common ground on policy solutions related to cost and value. Finally – two important players understand that they are, in fact, on the same team. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - January 30, 2016 Category: Pharmaceuticals Source Type: blogs
Wockhardt and get ahead?
Indian drugmaker Wockhardt hid the results of failed tests and deleted data from its systems at a plant in western India, according to a report by the U.S. Food and Drug Administration. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - January 30, 2016 Category: Pharmaceuticals Source Type: blogs
The Biosimilar Qualifier
The World Health Organization has posted a final version of its proposed biologics naming policy. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - January 27, 2016 Category: Pharmaceuticals Source Type: blogs
CDER House Rules
The recent mega-storm allowed many of us drugwonks to curl up with a new work of action non-fiction … from the FDA: Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2016. It’s worth perusing in its entirety, but here are a few items to tickle your regulatory palate: (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - January 25, 2016 Category: Pharmaceuticals Source Type: blogs
Markey's Mark
Senator Edward Markey (D, MA) is using Senate rules to block the nomination of Rob Califf in an attempt to force the agency to rescind its approval of a prescription opioid for children and change its regulatory practices. Senator Markey is rightly concerned about opioids remaining atop the FDA’s list of “must address” items. But his “hold” on the Califf nomination will, if anything, hold back the agency from making progress on this urgent issue. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - January 25, 2016 Category: Pharmaceuticals Source Type: blogs
FDA and NBCDs: Do Not Pass GAO
The House Energy and Commerce Committee is calling on the GAO to evaluate whether the FDA’s regulatory pathway for generic versions of complex drugs is sufficient. Specifically, the committee sent a letter Dec. 10 asking the GAO to assess whether generic versions of nonbiologic complex drugs that are not fully characterized present challenges in meeting generic approval standards. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - January 13, 2016 Category: Pharmaceuticals Source Type: blogs
A New Cure Coalition
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - January 11, 2016 Category: Pharmaceuticals Source Type: blogs
David Bowie's cancer battle :You can neither win nor lose if you don't run the race
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - January 11, 2016 Category: Pharmaceuticals Source Type: blogs
Fab Mab? Look Beyond the Lab.
As we move ahead in the US with more biosimilars being submitted for approval – and for interchangeability – attention must be paid to patient outcomes. Case in point is research presented at the 2013 ACR/ARHP Annual Meeting that hasn’t as yet received the attention it deserves: Efficacy and Safety of CT-P13 (Infliximab Biosimilar) over Two Years in Patients with Ankylosing Spondylitis: Comparison Between Continuing with CT-P13 and Switching from Infliximab to CT-P13. Biosimilarity and measurement of efficacy is only one dimension. Attention must be paid to effectiveness relative to real-world patient outcomes data. ...
Source: drugwonks.com Blog - January 11, 2016 Category: Pharmaceuticals Source Type: blogs
