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Purdue CEO: The Year For Transformative M&A Is Here

 
• By Jessica Merrill

The private specialty pharma is shopping for a transformative deal or a series of smaller deals that will diversify the company into a new area outside of pain and CNS disorders, CEO Mark Timney says during interview.

Purdue Pharma LP is in the market for a big deal or a series of smaller deals that will diversify the private specialty pharma into new areas outside of pain and central nervous system disorders. “2016 is our year for the transformative deal,” CEO Mark Timney said during an interview at the Feb. 8 BIO CEO & Investor Conference in New York.

Timney has been expanding Purdue’s therapeutic area of focus beyond opioids since taking over as CEO of the company in...

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The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
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Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
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The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.