BioPharma Today

The Prasugrel Backlash: Another Black Eye for FDA’s Advisory Committee Process

Article preview from The RPM Report April 28, 2009

FDA is the first to acknowledge that a lot of things went wrong during the run-up to the prasugrel advisory committee meeting, not the least of which is how the agency handles allegations of intellectual bias among its members. For drug sponsors, it may mean that the rules of engagement have changed.

Follow-On Biologics Legislation Faces Tough Road Ahead; Momentum Stalled

Article preview from "The Pink Sheet" April 28, 2009

Prospects for enactment of follow-on biologics legislation appear limited in the near term, according to Capitol Hill players in the debate. Read on...

From Verus to Meritage: A Biotech Prototype for Tough Economic Times

Full article reprinted from Start-Up April 28, 2009

Prolific entrepreneur Cam Garner has a new model for start-ups. Gone are the days of raising huge A rounds to build commercial infrastructure and license in families of products. His two new firms, Meritage and Evoke, are narrowly focused on single assets, in each case a reformulation of an approved drug repositioned in an underserved specialty indication. Read more...

The Asia Corner - From the Editors of PharmAsia News

The Asia Corner - From the Editors of PharmAsia News April 28, 2009

In this BioPharma Today feature, the editors of PharmAsia News take a closer look each week at the most important biopharma developments from China, India, Japan, and the Pacific Rim.

Read today's features...

J&J Celebrates Simponi Approval With Schering – For Now

Full article reprint from "The Pink Sheet" DAILY - April 28, 2009

Schering-Plough and partner Johnson & Johnson found cause to celebrate FDA's approval of Simponi (golimumab) April 24, even as Schering waits to find out whether J&J will try to challenge ownership of the anti-TNF drug as a result of Schering's planned merger with Merck. Read on...

The Health Care Reform Corner – From the editors of "The Pink Sheet"

 The Health Care Reform Corner – From the editors of "The Pink Sheet"

What are policymakers and stakeholders in Washington saying and doing about health care reform? In this periodic BioPharma Today feature, the editors of "The Pink Sheet" and "The Pink Sheet" DAILY highlight some of the major developments chronicled in those publications.

Read today's features....

The 1% Solution to Health Care Reform

Article reprint from The RPM Report April 21, 2009

The CEO of the managed care industry trade association has a simple formula for health care reform: all stakeholders in the debate should come forward with proposals to trim their own annual growth by at least 1%. Read on..

Amgen's D-mab: The New EPO

Article preview from IN VIVO April 21, 2009

D-mab is the new EPO. At least, that's what Amgen is hoping as it awaits FDA approval for its next growth engine, denosumab (D-mab). Assuming the drug gets to market--and Amgen is very confident it will--the drug's success will depend largely on pricing. Read on...

The Asia Corner - From the Editors of PharmAsia News April 21, 2009

The Asia Corner - From the Editors of PharmAsia News April 21, 2009

In this BioPharma Today feature, the editors of PharmAsia News take a closer look each week at the most important biopharma developments from China, India, Japan, and the Pacific Rim.

Read today's features... 

Opioid Class REMS: FDA Wants Prescriber/Pharmacist Certification

Article preview from "The Pink Sheet" DAILY April 21, 2009
 
The class-wide opioid Risk Evaluation and Mitigation Strategy should include a certification process for prescribers, pharmacists and other heath care providers, a strong patient education component, and prescriber-patient agreements, according to questions posed by FDA in advance of a two-day public meeting set for May 27-28. Read on...