BioPharma Today

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

Coming in Monday's "The Pink Sheet" DAILY - Genentech Gets Warning Letter for Rituxan Promotion

HHS establishes Office of Consumer Information and Insurance Oversight, headed by former Missouri insurance commissioner Jay Angoff, to manage private insurance reforms under health reform law.

Latest News from "The Pink Sheet" DAILY - Icahn Tries To Rain On Genzyme's Investor Day Parade

Advisory Panelists' Experience Carries Weight In Acthar Debate

FDA's Peripheral and Central Nervous System Drugs Advisory Committee members cite their own use of the drug in voting that Acthar Gel is effective at treating infantile spasms.   read more

Coming in Wednesday's "The Pink Sheet" DAILY - Merck, Pfizer Report Q1 Earnings

Acura and King plan to submit an NDA for a version of their oxycodone formulation Acurox that contains impediments to abuse by snorting or injection but does not contain the niacin FDA says is ineffective at preventing oral abuse.

Latest News from "The Pink Sheet" DAILY - Dendreon Set To Ship Provenge Soon

Dendreon Set To Ship Provenge Within A Week

Demand expected to exceed supply as company builds manufacturing capacity.   read more