Headlines From "The Pink Sheet" DAILY

SEC Investigates Elan Over Disclosures of Clinical Trial Data and Side Effect Reports

At issue: July 2008 reports of PML cases linked to Tysabri and key trial data for its Alzheimer's medication; Wyeth also gets a subpoena.   read more

 

Public Plan's CBO Score Makes It Reconciliation-Friendly

As public option goes down in Senate Finance Committee, CBO score breathes life into the proposal if Democrats use budget reconciliation maneuver to pass health reform.   read more

 

Senate Finance Defeats Public Plan Tied To Medicare Rates; Debate Will Move To House-Senate Conference

Public option amendments voted down by the Senate Finance Committee, but debate over the public plan and linking it to Medicare rates is kicked further down the road to conference process.   read more

 

For Sale: Repros Suffers An FDA Clinical Hold And Potential NASDAQ Delisting

FDA asks Repros to determine whether a lower dose of Proellex will lessen liver toxicity risks, but the company is strapped for cash.   read more

 

GSK Cervarix PDUFA Delay: Broad Label and Postmarket Plan Will Take Time

GlaxoSmithKline announced another delay Sept. 29 on the extended regulatory road for the HPV vaccine in the U.S.: but it may reflect good news. GSK needs a label that differentiates Cervarix from Gardasil. A quick review after the Sept. 9 advisory committee might have precluded the label it needs.   read more

 

Taking a BiTE Out of Cancer: An Interview With Micromet CEO Christian Itin

After securing $80.5 million in financing in August and renegotiating a partnership with MedImmune, Micromet is on course to take its first BiTE antibody into pivotal trials in 2010.   read more

 

FDA Advisory Committee To Review Human Genome Sciences' Anthrax Treatment

The U.S. government already has a stockpile of Human Genome Sciences' ABthrax (raxibacumab) for emergency use.   read more

 

Players That Evolve In Tandem With China's Health System Reforms Will Survive and Prosper, Says Pfizer Executive

Pfizer and French micro-credit group are exploring new approaches to help poor in China access medical care and medicines; Pfizer also testing micro-finance programs in India to help build rural health clinics.   read more

 

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