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May 11, 2018

Today's Rundown

Featured Story

Celldex plans life after glembatumumab, cutting 2 more drugs from pipeline

Still reeling from the failure of its lead breast cancer candidate glembatumumab vedotin last month, Celldex has culled another two pipeline projects and now says it will focus its R&D efforts mainly on two cancer antibodies.

Top Stories

In split vote, FDA advisory committee backs Akcea/Ionis’ volanesorsen

An FDA advisory committee voted 12-8 on Thursday to recommend the approval of Akcea Therapeutics’ volanesorsen, an RNAi drug for rare lipid disorder familial chylomicronemia syndrome.

Ziopharm hits pause on planned pivotal brain cancer trial

Ziopharm Oncology has hit pause on a planned pivotal trial of Ad-RTS-hIL-12 in brain cancer patients. Management took the action after technical issues slowed progress of the inducible adenoviral vector.

[Sponsored] Optimize Human Gene Transfer Trials: Create Efficiencies with Coordinated IRB & IBC Review

Avoid delays in gene transfer trial start-up with tips from leading IRB and IBC experts.

Faron fingers low bioactivity as possible cause of phase 3 flop

Faron Pharmaceuticals has zeroed in on low levels of interferon-beta bioactivity to explain why its phase 3 traumakine trial failed comprehensively. The biotech is now testing product batches to assess whether the formulation is to blame for the lackluster data.

Semma names former Novartis, Magenta executive as new CEO

Regenerative medicine developer Semma Therapeutics is bringing on Bastiano Sanna, formerly of Novartis’ cell and gene therapy unit and Magenta Therapeutics, to serve as its president and CEO following a $114 million funding round late last year.

Mayo Clinic and AliveCor use AI to detect ‘invisible’ heart condition

Investigators from the Mayo Clinic and AliveCor demonstrated that a trained artificial intelligence network can help identify people at increased risk of arrhythmias and sudden cardiac death, despite displaying a normal heart rhythm on their electrocardiogram.

EuroBiotech Report—Autolus IPO, Abcam-Horizon, Faron fail, Promore and Pluristem

In this week's EuroBiotech Report, Autolus files for a $100 million IPO, Abcam drops its Horizon buyout plan, Faron drug flunks phase 3 and more. 

FiercePharmaAsia—Takeda-Shire reach finish line, Hong Kong prerevenue IPO, AstraZeneca’s asset sale

After shaking hands with Shire on a $62 billion merger deal, Takeda lays out a plan for major cuts; Ascletis becomes the first company to file for an IPO under Hong Kong Exchange's revised listing rules for prerevenue biotechs; AstraZeneca offloads Seroquel rights to China's Luye Pharma; and more.

Chutes and Ladders—Atara hires ex-Genentech SVP to lead R&D

Atara hires ex-Genentech SVP to lead R&D, Semma names former Novartis CAR-T developer as CEO and GSK's CFO heads for the exit. Read about those moves plus more hirings, firings and retirings throughout the industry.

Resources

[Whitepaper] Compliance Certificate and Training for Life Sciences Professionals

4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics.

[Whitepaper] 2018 Life Sciences Trends

What are the biggest trends in life sciences this year?

[Whitepaper] Choosing the Best Steriles Dosage Form for Your Phase I Clinical Supply Needs

There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. In this article, the author discusses the choices available and strategies which can be employed at the different stages of development.

[Whitepaper] The Future of Life Sciences Events Management

Explore a new model for events management, and learn how to deliver more value.

[Whitepaper] Leveraging Scientific Insights for Better Healthcare Engagement

To deliver value to key opinion leaders, medical affairs needs to tailor their engagement with deeper analytics and insights.

[Whitepaper] MSL Outlook: What is the Future of Field Medical Affairs?

Learn how leading companies, from the world’s top pharma to emerging biotechs, are empowering their medical affairs teams.

[Whitepaper] Risk-based Approach to Change Management of GxP Systems

Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems.

[Whitepaper] Regulatory Transformation at UCB

UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off.

[Whitepaper] Five Tracking Spreadsheets it’s Time for Regulatory to Retire

Find out how to eliminate regulatory’s tracking spreadsheets for good.

[Whitepaper] A Simpler Approach to RBM in Clinical Trial Management

Learn how cloud-enabled solutions provide real-time insights and actionable analytics to improve clinical trial safety and performance in this short presentation.

[Whitepaper] Digitizing the Global Life Sciences Supply Chain: The Critical Role of Digital Transaction Management

Life science companies are experiencing a significant transformation in how they bring new products to market.

Events

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