BioPharma Today

“Breakthrough Therapy” Development Speed May Be Tempered By Manufacturing Hurdles

Article preview from "The Pink Sheet"-  November 26, 2012 

Sponsors and FDA also will have to work through issues related to companion diagnostics to prevent treatments designated under the FDASIA’s new expedited development pathway from being delayed. Harmonization with foreign regulators is essential to making the pathway work, stakeholders say.

FDASIA Is Signed, Not That White House Wanted Anyone To Notice

Article preview from "The Pink Sheet"-  July 16, 2012

White House sends out short press release as FDA is conducting an unrelated briefing to announce the user fee bill was enacted, surprising stakeholders and generating political questions.

Did PDUFA V Pass Too Quickly?

Article preview from "The Pink Sheet"-  June 25, 2012

The pending Supreme Court decision on the Affordable Care Act may have forced negotiators to finish quicker than they would have liked as legislators indicate some more time may have produced an agreement on track-and-trace standards; stakeholders may question whether the bill could have been improved had the deadline not been looming.

User Fee Conference Cmte. Could Be Relatively Messy After Clean Floor Votes

Article preview from "The Pink Sheet"-  June 4, 2012

House and Senate avoided some contentious issues when passing their user fee bills, leaving them to an informal conference committee to work out, ideally before the end of June.

House Patent Reform Bill: Battle Looms Over Reexam, Prior User Rights Provisions

Article preview from "The Pink Sheet"-  April 4, 2011

The six-year battle over patent reform legislation is not yet over as the pharmaceutical and biotechnology industries and other leading stakeholders are unhappy with provisions in the House bill that differ from the recently passed Senate measure.

A Closer Look: Decision For No Medicare NCD On ESAs In Renal Disease Would Be The Exception

Article preview from "The Pink Sheet"-   March 28, 2011

Many industry watchers were surprised when the Centers for Medicare and Medicaid Services conducted an extensive evidence analysis of ESAs, only to propose on March 16 no policy change. Indeed, the outcome, if made final, would be quite unusual, a look at numerous coverage analyses shows.

If States Win Lawsuits Against Health Reform Law, How Might Pharma Fare?

Article preview from "The Pink Sheet"- October 25, 2010

While it’s likely to be 2012 before a final decision is handed down in lawsuits states have brought challenging the constitutionality of the Patient Protection and Affordable Care Act, questions are already arising about the possible impact on the law's pharmaceutical-related provisions if the states prevail.

Latest News From "The Pink Sheet" DAILY - Avandia May Remain On Market With New Warnings, REMS

Avandia Can Be Saved With New Warnings and REMS, Advisory Cmte. Says

Latest News from "The Pink Sheet" DAILY - Cephalon Looks For Growth As Nuvigil Fails Schizophrenia Trial

Arena Gets Financing Boost, Lorcaserin Advisory Committee Date

Deerfield takes a $35.5 million equity stake, but finding a commercialization partner is still Arena's focus as it prepares for the September 16 panel review of its obesity drug.   read more

Latest News From "The Pink Sheet" DAILY - FDA Committee May Support Narrow Use Of Rezield

AstraZeneca's Rezield Might Itself Be Saved By Sicker Patients