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November 16, 2018

Today's Rundown

Featured Story

AstraZeneca’s Mystic OS analysis paints tremelimumab as a dud in NSCLC

Overall survival data from AstraZeneca’s phase 3 Mystic trial have cast more doubts on the prospects of anti-CTLA4 antibody tremelimumab. The readout suggests that, if anything, adding tremelimumab to PD-L1 drug Imfinzi results in worse outcomes in metastatic non-small cell lung cancer (NSCLC).

Top Stories

Lori Kunkel takes acting CMO role at gene therapy firm Tocagen

Tocagen has named Lori Kunkel as its acting chief medical officer following the departure of Asha Das, who is leaving because of “unforeseen and immediate personal matters.”

MorphoSys partners anti-C5aR I-O antibody with I-Mab

MorphoSys has partnered with I-Mab to support development of anti-C5aR antibody MOR210. The deal sees I-Mab agree to take the immuno-oncology candidate up to clinical proof of concept.

[Sponsored] Global Life Science Services Platform Unites Under New Name, EVERSANA

EVERSANA delivers a fully-integrated service portfolio to help life science leaders create value for key constituents across the product lifecycle.

Belgium’s Camel-IDS reels in €37M to push breast cancer radiotherapy

Camel-IDS raised €37 million ($42 million) in series A financing to run a phase 1b/2 trial of its lead program, a radioactive compound dubbed CAM-H2, in HER2-positive breast cancer that has spread to the brain.

[Sponsored] Mining Real-World Data With Cutting-Edge Analytical Tools

In 1848, the most famous Gold Rush in American history began at Sutter's Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for many, a shattered dream.

EuroBiotech Report—UniQure hemB data, Themis scraps IPO, Boehringer backs Amal and more

In this week's EuroBiotech Report, uniQure clears a hemophilia B test, Themis scraps its planned IPO, Boehringer backs Amal and more. 

FiercePharmaAsia—Samsung BioLogics' crisis; Merck's Gardasil supply; China’s vaccine solution

Samsung BioLogics faces potential delisting and CEO dismissal over accounting fraud; Merck promises quadrupled Gardasil supply to China; Chinese regulators seek to tighten regulation of the vaccine market on the back of a high-profile scandal; and more.

Chutes & Ladders—Dermavant hires Todd Zavodnick as CEO

Dermavant has hired Todd Zavodnick as CEO; Bayer VP Alan Westwood will lead antimicrobial firm Matoke Pharma; Genentech I-O leader Wei Lin will head up Nektar's oncology work; and Google is bringing on Geisinger’s CEO to direct its healthcare efforts. Those moves plus more hirings, firings and retirings throughout the industry.

Enrollment Showcase

BioBasics Dec. 5-6

BioBasics is an intensive two-day course starting with a review of the healthcare sectors and the scientific concepts required for understanding the biopharma industry, then delves into the cause of genetic and infectious disease, diagnostics and strategies used to mitigate disease and finally the latest innovations in biopharma are explained. Register today!

Resources

[Report] Clinical Operations Report: Learn the Top Industrywide Priorities

Industry Research: Read the 2018 Unified Clinical Operations Report to find out how pharmas and CROs are evolving clinical trial processes.

[Research Report] Challenges And Opportunities In Clinical Data Management

New research reveals more than 50% of clinical data management professionals surveyed, are not confident in the quality and completeness of their clinical trial data.

[Whitepaper] Migraine Treatment and Calcitonin Gene-Related Peptide Inhibitors: Real-World EHR Case Study

New Case Study – Leveraging Real-World Evidence From EHR to Assess Migraine Management

[Whitepaper] The Future of Cell & Gene Therapy

What does data tell us about the future of cell & gene therapy?

[Whitepaper] Choosing the Best Sterile Dosage Form for Your Clinical Supply Needs

Download the whitepaper to learn more.

[Whitepaper] Why Life Sciences Companies Leverage Managed Regulated Infrastructures

Outer Edge Technology specializes in designing and managing regulated cloud-based infrastructures for the Life Sciences Industry – typically leveraging the AWS and Microsoft Azure platforms.

[Infographic] Accelerate Your Early Drug Delivery Journey

In the United States, it takes an average of 12 years for an experimental drug to travel from the laboratory to a patient’s medicine cabinet. The average cost to research and develop a successful drug is approximately $2.6 billion.

[Workshop] Smart Drug Development & Design from Candidate to Phase I

Today’s scientists are under significant time pressure to accelerate their compound from discovery to the clinic. Such pressure can often lead research organizations to adopt short-term thinking and overlook the downstream realities of drug development.

[Executive Summary] From Candidate to Clinic

What is the fastest way to success? It is critical that drug developers execute several elements related to planning, investment, and understanding of the risks, risk tolerance, and pitfalls inherent in the drug development program.

[eBook] 2018 State of Technology in Clinical Research

Discover what over 800 of your peers think about technology's impact on clinical trial operations.

[eBook] 2018 Weekly Compendium

The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry.

[eLearning] BIOAVAILABILITY 101

Develop a basic understanding of principles and concepts of bioavailability of oral drugs.

Events

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