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

Members of FDA's Antiviral Drugs Advisory Committee say that MedImmune's RSV drug Rezield (motavizumab) doesn't pass the risk-benefit test for healthier patients, but it might for sicker patients.   read more

 

Foreign Trials, U.S. Liability: Pfizer Dealt Setback As Solicitor General Asks Supreme Court Not To Review Nigerians' Trovan Suit

If the Supreme Court lets appeals court decision stand, pharmaceutical firms could find themselves facing more litigation regarding clinical trials conducted overseas.   read more

 

Constellation Brings In Series B Totaling $22 Million, Including GSK Investment

Involvement by GSK's venture arm SR One enables Constellation to keep pace with epigenetics competitor Epizyme, which is backed by Amgen and Astellas.   read more

 

Rx Fraud Investigations Could Get Boost From Health Care Reform's Transparency Requirements

Former DoJ prosecutor Michael Loucks says there is pressure from Congress to exclude companies from government programs, particularly if they have prior settlements with the government.   read more

 

Novo Nordisk Faced Tough Decision in Greece: Cut Prices And Make A Loss Or Oppose Government Plans

Danish drug maker turns up pressure on Greek government to reverse its price cut demands.   read more

 

J&J Faces Possible Criminal Liability As Post-Recall Overhaul Continues

FDA could seek misdemeanor charges against J&J officers under the Park Doctrine, which can be invoked against executives who could have prevented adulteration or misbranding of a drug. California Republican Issa says regardless whether criminal indictments come, the case "could be fair warning" to other firms regarding quality system failures.   read more

 

 

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