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June 23, 2017

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Today's Rundown

  1. Bluebird Bio rebuilds case for blood disorder gene therapy

  2. Aveo soars as long-beleaguered cancer drug nears approval

  3. Novartis-backed GenSight gets cash for gene therapy launch

  4. [Sponsored] PAREXEL’s Connected Journey™ of Data-Driven Services

  5. FDA rejects Pfizer's Epogen biosimilar for a second time

  6. EuroBiotech Report—Johnson & Johnson’s $1B spinout, Prostvac trial delay, Woodford invests in dementia, Cell Medica and ElexoPharm

  7. FiercePharmaAsia—China’s ICH membership, Takeda’s $111M plant, Ipca ban

  8. Chutes & Ladders—BIO elects John Maraganore as new chair

Featured Story

Bluebird Bio rebuilds case for blood disorder gene therapy

Bluebird Bio reported encouraging data on its revamped gene therapy for sickle cell disease and beta thalassemia this morning, but shares slipped 6% premarket on some unresolved issues.

Top Stories

Aveo soars as long-beleaguered cancer drug nears approval

Aveo Pharmaceuticals’ troubled tivozanib is on the cusp of winning approval in Europe. Drug assessors in the region gave the thumbs-up to the tyrosine kinase inhibitor in kidney cancer, sending Aveo’s stock on a tear and teeing up its partner to bring the drug to market.

Novartis-backed GenSight gets cash for gene therapy launch

GenSight Biologics has raised €22.5 million ($25.2 million) to prepare to bring gene therapy GS010 to market in the U.S. and Europe. The financing gives the Novartis-backed biotech enough cash to deliver data from two phase 3 trials next year and gear up for anticipated approvals on both sides of the Atlantic.

[Sponsored] PAREXEL’s Connected Journey™ of Data-Driven Services

How PAREXEL's New Ecosystem of Technology, Processes and Expertise is Transforming Drug Development

FDA rejects Pfizer's Epogen biosimilar for the second time

Just a month after FDA staff and an advisory committee gave a ringing endorsement to Pfizer's biosimilar for Amgen's blockbuster Epogen, the agency has rejected the drug for the second time.

EuroBiotech Report—Johnson & Johnson’s $1B spinout, Prostvac trial delay, Woodford invests in dementia, Cell Medica and ElexoPharm 

In this week's EuroBiotech Report, Johnson & Johnson spins out Idorsia, Bavarian Nordic delays data, Woodford backs dementia fund and more.

FiercePharmaAsia—China’s ICH membership, Takeda’s $111M plant, Ipca ban

China’s FDA joined ICH as a regulatory member, Takeda wrapped up construction of new solid dosage plant in Germany, the FDA bans imports of Ipca Lab drugs.

Chutes & Ladders—BIO elects John Maraganore as new chair

BIO elected Alnylam CEO Maraganore as new chair, Neon tapped ex-Merrimack CFO Yasir Al-Wakeel, Biogen hired ex-Shire exec Ginger Gregory to lead human resources. Plus more hirings, firings and retirings throughout the industry.

News of Note

CSL Behring won FDA approval for its rival to Shire's hereditary angioedema franchise. Statement

AbbVie and Gilead picked up regulatory nods in Europe, opening a new phase of their hepatitis C scrap. Release (PDF)

Shares in Cara Therapeutics rose after the FDA bestowed breakthrough status on CR845. Statement

Resources

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[Webinar] Going Digital: Connecting Submission Documents and Regulatory Data

Hear three innovative leaders explain how regulatory can “go digital” in their operations by leveraging the data-handling capabilities in their RIM systems.

[Webinar] Outsourcing complex microsurgeries – is it worth the risk?

Performing a sophisticated surgery to create a myocardial infarction model. Join us on June 7th at 11:00 AM EDT.

[Webinar] Within-Subject Clinical Trials: Intro to New Methods & Stat. Models

In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods.

[Webinar] Leveraging Medical Insights for Better Healthcare Engagement

Join this global webinar to learn a new approach for demonstrating medical affairs' impact with better metrics - beyond reach and frequency, enabling launch success and better engagement with strategic KOL insights, and increasing your organization's share of voice in the healthcare landscape.

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[Whitepaper] DocuSign Life Sciences eBook: Reducing Cycle Time with Digital Transaction Management

The patients who rely on your scientific leadership are expecting more.

[Whitepaper] Streamline Regulatory Compliance in Life Sciences with Digital Transaction Management

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.

Events

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