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Embattled Lab Nears Settlement With Government Over Kickbacks

Health Diagnostic Laboratory Inc, the embattled lab company, is nearing a $50 million settlement with the Justice Department, according to a Wall Street Journal story by  John Carreyrou… 110 more words

Policy & Ethics

Should You Be Worried About The Neurocognitive Side Effects Of The New Cholesterol Drugs?

The big news yesterday was important additional information about the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi/Regeneron. As I reported then, the studies were broadly consistent, showing the powerful cholesterol-lowering effects of the drugs and providing an early suggestion that the drugs  118 more words

Policy & Ethics

What A Long Strange Trip It's Been: FDA Approves Watchman Device From Boston Scientific

Finally reaching its destination after an extremely long and strange trip, Boston Scientific gained approval from the FDA today to market its Watchman Left Atrial Appendage Closure Device in the US. 32 more words

Policy & Ethics

High Risks And Rewards Found With Heart Valve Device From Edwards And Medtronic

Transcatheter aortic valve replacement (TAVR) is one of the most important advances in cardiovascular medicine in recent years. TAVR devices, introduced recently in the US by Edwards Lifesciences and Medtronic, are associated with very high risks, but offer a less invasive alternative to traditional aortic valve replacement surgery. 78 more words

Policy & Ethics

Orexigen 'Crying All The Way To The Bank' After 'Egregiously Unethical' Actions

On Tuesday morning the members of the Data Monitoring Committee of Orexigen’s Light study began a planned meeting in a hotel in Chicago. They had no way of knowing that in a few hours their routine duties would be completely interrupted by the news that data from the trial– which they thought was known only to them and a very few other people within the company and the FDA– had been revealed to the world by Orexigen. 164 more words

Policy & Ethics

Takeda Disagrees With Orexigen Over Data Disclosure

(Updated)

On Tuesday Orexigen sparked a firestorm by disclosing the interim results of an ongoing clinical trial of its weight loss drug Contrave. Takeda, which markets the drug in the US, has released a statement in which it states that it does  405 more words

Policy & Ethics

Orexigen Released Interim Data Without Approval Of Trial Leaders

Earlier today Orexigen Therapeutics disclosed positive results from a clinical trial of Contrave, its weight loss pill (a combination of naltrexone and bupropion) that it markets with Takeda. 148 more words

Policy & Ethics