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November 26, 2018

Today's Rundown

Featured Story

FDA hits Zafgen’s beloranib successor with clinical hold

The FDA has placed a clinical hold on Zafgen’s ZGN-1061. Zafgen suffered the blow after failing to allay the FDA’s concerns that ZGN-1061 will face similar cardiovascular safety problems to its predecessor, beloranib.

Top Stories

After gene therapy pivot, Axovant bolsters its executive ranks

After switching its focus midyear from Alzheimer’s disease to gene therapy, Axovant is appointing a slew of new executives, including a pair of Novartis alums and several biotech veterans, to posts ranging from clinical development to commercial operations.

Vir starts trial of RNAi drug for hep B seeking functional cure

Vir Biotechnology has started a phase 1/2 trial of its gene-silencing drug for hepatitis B virus, the first clinical candidate from its partnership with Alnylam Pharmaceuticals.

[Sponsored] Minimal Residual Disease: Application in Blood Cancers

A diagnosis of chronic lymphocytic leukemia (CLL) can mean a long road with many twists and turns as patients try to achieve long-term remission from this chronic, complex and progressive form of blood cancer.

Vectura cans VR475 after it fails phase 3 asthma test

A phase 3 trial of Vectura’s VR475 in patients with severe uncontrolled asthma has missed its primary endpoint. The blow prompted Vectura to halt work on the nebulized formulation of the budesonide.

Illumina leads €16M round for digital PCR firm Stilla Technologies

Illumina’s venture arm led a €16 million ($18 million) series A round for Stilla Technologies, a Paris-based developer of digital PCR solutions for genetic analysis.

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

[Webinar] Becton Dickinson’s Digital P2P Solution Simplifies Spend Management

Learn how Becton Dickinson implemented Coupa to create an easy-to-use purchase to pay process that increased efficiency across the organization.

[Whitepaper] Evaluation of the claraT Total mRNA report in an RNA- Sequencing dataset from malignant melanoma cancer patients treated with Ipilimumab

Download the whitepaper to learn more.

[Whitepaper] Putting the Researcher in the Driver’s Seat

Learn how to fast-track your research workflows!

[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.

[Webinar] QSP Approaches to Determine Best in Class Properties for Targeted Anabolic Growth Factor to Arthritic Joints

This on-demand webinar introduces a quantitative systems pharmacology (QSP) model of targeted anabolic growth factors for intra-articular injection for the treatment of diseased joints.

[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 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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