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BioMarin's Duchenne Drug Is Done, Sarepta Survives but Faces Challenge

I give BioMarin a 5% chance of winning approval for drisapersen from the FDA following a negative advisory panel. I might be too generous.

BioMarin FDA Panel Live Blog
BioMarin FDA Panel Live Blog

11/24/15 - 07:39 AM EST

A panel of outside experts convened by the U.S. Food and Drug Administration will spend all day Tuesday reviewing drisapersen, BioMarin's experimental drug for Duchenne muscular dystrophy (DMD).

Clovis Blowup Conjures Bad Biotech Memories of ImClone Darkness

The last thing the biotech industry needs today is another hit to investor credibility. Clovis isn't helping.

MannKind Elder Abuse Is Replacing Inept CEO With Founder

It's almost cruel to see Al Mann being forced back into the CEO role at MannKind, but the company's near-total collapse demands it.

BioMarin Duchenne Drug Receives Harsh Review From FDA

The FDA is highly critical of BioMarin Pharmaceuticals' drisapersen, concluding that efficacy data from three clinical trials do 'not reach the level of substantial evidence' necessary for approval.

These Biotech Stocks Could Move on BioMarin's Duchenne Drug FDA Panel

BioMarin will almost certainly be halted all day Tuesday, so traders should watch Sarepta Therapeutics and PTC Therapeutics as proxies.

How to Prepare for BioMarin's (and Biotech's) Biggest Event of 2015

On Nov. 24, a panel of outside experts convened by the U.S. Food and Drug Administration is set to review drisapersen, BioMarin's experimental drug for Duchenne muscular dystrophy.

Clovis Craters on Lung Cancer Drug-Review Delay

Clovis Oncology must submit additional clinical data on its targeted lung cancer drug rociletinib to U.S. regulators, delaying the approval review and putting the company further behind rival AstraZeneca.

Biotech Stock Mailbag: Relypsa, Sophiris, Bluebird, Zafgen, NW Bio

Biotech columnist Adam Feuerstein answers readers' questions about health care.

MannKind Discovers Israel Isn't the Promised Land

MannKind manages to raise a fraction of the money hoped from Israeli investment funds.

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