Latest News from "The Pink Sheet" DAILY - Endo Explains HealthTronics Acquisition to Wall Street

Endo Explains HealthTronics Acquisition to Wall Street: Relationships With Urologists Are Key

Endo's pending acquisition of HealthTronics and its settlement with Impax and Sandoz over generic Opana ER removes some near-term pressure on its shares.   read more

 

Multi-Regional Trials Prompt FDA Interest In Sponsors' Trial Infrastructure Decisions

The need to ensure data quality necessitates a better understanding of how the data was collected, CDER's Robert O'Neill tells DIA.   read more

 

Novo Nordisk's Pen Insulins Available Again In Greece As Government Raises Prices

A temporary pricing decree from the Greek government includes higher prices for 48 insulin products; permanent decree expected by September.   read more

 

For Nexavar In Lung Cancer, Focus Moves From First To Second Line

Nexavar failed to meet the primary endpoint of a second Phase III trial in first-line lung cancer, but Bayer/Onyx remain optimistic about prospects for the drug in the disease based on biomarkers.   read more

 

Rapamune Off-Label Suit Prompts Congressional Investigation

House Oversight Committee is investigating allegations Wyeth promoted Rapamune for unapproved uses. Chairman Towns says he is concerned the drug was targeted to high-risk African-Americans; Pfizer says the drug is not contraindicated for this population.   read more

 

FDA To Regulate Direct-To-Consumer Genetic Tests

Citing the need to prove that direct-to-consumer genetic assays are analytically and clinically accurate, CDRH sent letters to five genetic testing firms June 10 requesting pre-market submissions for the companies' already-marketed services.   read more

 

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