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November 08, 2019___

Today's Rundown

Featured Story

Sarepta CEO dispels FDA 'bias' theory, but no update on when CRL will be resolved

Sarepta Therapeutics' chief Doug Ingram has come out against accusations that the FDA is biased against the company after its recent drug rejection but offered no timing on when the agency's concerns will be fixed.

Top Stories

AnaptysBio's IL-33 antibody stumbles in midphase eczema trial

After clearing a midstage study in asthma last fall, AnaptysBio’s anti-IL-33 antibody missed the mark in a phase 2b trial testing it in atopic dermatitis, or eczema. The drug, etokimab, did worse than placebo at easing symptoms such as itch and skin inflammation after 16 weeks of treatment.

Monopar Therapeutics puts the brakes on IPO, again

It's déjà vu for cancer biotech Monopar Therapeutics as the company delays getting off its initial public offering for the second time.

[Sponsored] Flip the Funnel: Rethinking Patient Recruitment and Enrollment Strategies

No matter how successful advertising campaigns are, all that really matters is how many referrals ultimately participate in the trial. It’s time to flip the funnel and focus on converting recruits into enrollees.

FTC orders artificial limb maker Ottobock to undo and divest its knee acquisition

After two years, the Federal Trade Commission has ordered the German prosthetics company Ottobock to roll back its acquisition of Freedom Innovations, saying the merger of the two manufacturers would weaken competition in the market for computer-controlled prosthetic knees.

EuroBiotech Report—AstraZeneca in China, Novo's pipeline, Vifor and Ipsen

In this week's EuroBiotech Report, AstraZeneca steps up committment to China, Novo adjusts pipeline and Vifor allies with Evotec.

FiercePharmaAsia—Amgen-BeiGene $2.7B tie-up; AZ's China projects; controversial Alzheimer's drug

Amgen is taking a 20.5% stake in BeiGene, which will help the Big Biotech develop cancer drugs in China. AstraZeneca, along with several Big Pharma companies, tightens its ties to China. A newly approved Alzheimer's drug from a Chinese firm raises questions. And more.

Chutes & Ladders—Teva names replacement for outgoing CFO McClellan

Teva picks Flex's Kalif to replace CFO McClellan; Endo head Campanelli heads out; Hahn gets pick to be FDA chief.

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Resources

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[Whitepaper] How to succeed by failing faster

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[Article] 8 Compelling Reasons Why Businesses Need To Be In The Cloud Now!

Companies that don’t have a cloud strategy are at a competitive disadvantage. Why? The cloud has a measurable impact on business.

[Whitepaper] Implementing On-Dose Authentication Technologies for Solid Dose Drug Products

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[Case Study] Clinical Supply Management

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[Video] Demand Led Services and Clinical Supply Efficiency

Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels.

[eBook] Strategies for Efficient Clinical Supply Management and Forecasting

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