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April 21, 2017

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Today's Rundown

  1. XBiotech slumps on likely EMA rejection of cancer drug

  2. Gilead says first data on Nimbus NASH candidate are positive

  3. Vernalis falls after FDA knocks back cough-cold drug filing

  4. 'Priming' protein boosts stem cell response to injury, promotes healing

  5. EuroBiotech Report—U.K. EMA hopes crushed, Roche phase 3 data, Circassia fails again and CRUK, NCI sign Ras deal

  6. FiercePharmaAsia—China pharma market prospect, Hanmi’s negligence, Celgene’s Asia-Pacific collaboration

  7. Chutes & Ladders—Embattled Juno taps new R&D head

Featured Story

XBiotech slumps on likely EMA rejection of cancer drug

The European Medicines Agency’s (EMA) drug approval committee has indicated it is likely to reject XBiotech’s metastatic colorectal cancer candidate when it holds a formal vote next month. Shares in XBiotech slumped following the news.

Top Stories

Gilead says first data on Nimbus NASH candidate are positive

Gilead Sciences has unveiled the first proof-of-concept data for its novel drug candidate for nonalcoholic steatohepatitis (NASH) as it tries to rebuild confidence in its R&D pipeline.

Vernalis falls after FDA knocks back cough-cold drug filing

The FDA has knocked back Vernalis’ filing for approval of CCP-07. The setback wiped 12% off Vernalis’ stock price in early trading as investors weighed the impact of the at-best-delayed approval of a cough-cold drug projected to generate peak sales of $150 million (€140 million) to $500 million.

'Priming' protein boosts stem cell response to injury, promotes healing

Stanford University scientists have identified a protein that, given before an injury, boosts stem cell response and improves healing. “Priming” with this protein could eventually speed recovery in cases where injury is expected, such as patients undergoing surgery.

EuroBiotech Report—U.K. EMA hopes crushed, Roche phase 3 data, Circassia fails again and CRUK, NCI sign Ras deal

In this week's EuroBiotech Report, EU crushes U.K.’s EMA hopes, Roche shares look at hemophilia A data, Circassia fails again and more.

FiercePharmaAsia—China pharma market prospect, Hanmi’s negligence, Celgene’s Asia-Pacific collaboration

Novartis' CEO said China's pharma market will surpass $300 billion by 2020, Hanmi was found breaking two medical laws when it failed to disclose olmutinib trial side effect on time, Celgene tapped Antengene as its first Asia-Pacific partner.

Chutes & Ladders—Embattled Juno taps new R&D head

Juno tapped Genentech alum Sunil Agarwal as new R&D chief, Merrimack promoted Onivyde scientist Daryl Drummond as head of research, and Mitch Gold leads the newly merged and soon-to-be-public Alpine. Plus more hirings, firings and retirings throughout the industry.

News of Note

The Medicines Patent Pool has penned a new license and tech transfer deal with Egypt's Pharco Pharmaceuticals for its pan-genotype hep C candidate ravidasvir. Release

Former Monsanto and Synergy Pharmaceuticals exec Kunwar Shailubhai has been named as the new CEO at blood cancer biotech Rasna Therapeutics. Statement

Bloomberg data show that biopharma M&A has yet to pick up, with pharma and biotech acquisitions just $44 billion last quarter, down 13% from a year earlier, and 35% below the first quarter of 2015. Bloomberg story

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The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company.

[Survey] Veeva 2017 Unified Clinical Operations Survey

Share your thoughts on the life sciences industry’s progress in reducing system and process complexity to improve study execution. The first 50 qualified respondents will receive a $10 Amazon gift card, as well as a $10 donation made to Doctors Without Borders in their name. Finish the survey today!

[Whitepaper] A Dose of Shared Services: Why Big Pharma is Turning South

As life sciences companies decide to implement shared services, a major concern is real estate costs for a facility. Download this Whitepaper to learn why Florida is gaining traction as a prime location for shared services.

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