BioPharma Today

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

Latest News From "The Pink Sheet" DAILY - Glaxo Unimpeded By Health Care Reform

Merck Names Ken Frazier President

Latest News from "The Pink Sheet" DAILY - Merck Puffs Up Respiratory Portfolio, Gets EU Rights To Nycomed's Daxas

New MannKind Data Appear Positive, But Doubts Persist About Afrezza's Viability

Pulmonary function data don't resolve questions about safety, analysts argue.   read more

Latest New from "The Pink Sheet" DAILY - King/Acura's Acurox Gets FDA Avisory Review

Alimera Raises $72 Million In IPO; Clips Share Price To $11 From Initial $15-$17 Range

$15 million will be used to pay debt to Australian drug maker pSivida, which gave Alimera its lead compound.   read more

Coming in Friday's "The Pink Sheet" DAILY - PTO Is Prepared to Implement Bilski Ruling

The U.S. Patent and Trademark Office has set up a task force to implement the Supreme Court's forthcoming ruling in the Bilski case as to what is patentable subject matter. PTO official Arti Rai tells a meeting of the Biotechnology Industry Organization about the agency's efforts to push through patent reform leegislaiton and reduce the pendency of patent applications by 40 percent.

Coming in Thursday's "The Pink Sheet" DAILY - Genzyme, Abbott Report Q1 Earnings

Sen. Byron Dorgan of North Dakota and Gov. Brian Schweitzer of Montana seek permission from HHS to conduct a demonstration project allowing residents of their states to buy drugs imported from Canada.

Genzyme is making progress in structuring a consent decree with FDA, the company reported during its first quarter earnings call April 21. A draft the agency sent to Genzyme would impose an upfront payment of $175 million based on past profits from products made at the troubled Allston Landing, Mass., manufacturing facility. Genzyme, which reported sales declines for the two drugs most affected by the Allston situation – Cerezyme and Fabrazyme – also could face royalties of 18.5 percent on products made and distributed from the facility if certain deadlines are not met.

Abbott expects U.S. health care reform legislation to negatively impact 2010 sales by about $230 million, which led the pharma to lower its full year earnings per share guidance, execs told investors during an April 21 first quarter earnings call.

Latest News from "The Pink Sheet" DAILY - Novartis' Sandoz Unit Makes Respiratory Push

Pharmerging Markets Expected To Keep Sales Growth "Strong" Through 2014, IMS Says

IMS forecasts a 5 percent to 8 percent growth of global pharmaceutical sales annually through 2014. read_more_>