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November 20, 2018

Today's Rundown

Featured Story

LEO Pharma inks $760M rare skin disease R&D deal with PellePharm

LEO Pharma has signed a research collaboration deal with PellePharm that commits up to $760 million for late-stage trials and includes an option for LEO to acquire the small rare disease company outright at some point in the future.

Top Stories

Roivant takes aim at resistant infections with $667.5M Intron deal

Fresh from a $200 million fundraising that pushed its valuation above $7 billion, Roivant Sciences has spent more money on its R&D portfolio, licensing a midstage drug for resistant bacteria from South Korea’s Intron Biotechnology.

Enlivex to merge with BioBlast, bagging Nasdaq listing

Enlivex Therapeutics is set to bag a Nasdaq listing through a reverse merger with BioBlast Pharma. News of the merger comes as Enlivex gears up for a multi-indication phase 2 and 3 trial push for its immunotherapy Allocetra.

[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.

Lilly's Robert Brown to lead Brickell Bio as it eyes phase 3 dermatology trials

Eli Lilly VP Robert Brown is making the jump to serve as CEO of the skin disease-focused Brickell Biotech, as it prepares to move its lead candidate into phase 3 trials for excessive underarm sweating next year.

Synthego expands CRISPR kit reach with Eurofins distribution deal

Synthego has tapped Eurofins Genomics to distribute synthetic single guide RNA products from its CRISPRevolution line of genome-editing kits. The partnership adds Eurofins customers in 44 countries to Synthego’s market.

Stallergenes' allergy immunotherapy hits goal in phase 3

A phase 3 trial of Stallergenes Greer’s treatment for house dust mite-induced allergic rhinitis has met its primary endpoint. The late-phase success sets Stallergenes up to file for FDA approval of oral immunotherapy STAGR320.

FDA delays decision on Sage’s postpartum depression drug by 3 months

The FDA, which expected to approve or deny Sage Therapeutics’ brexanolone next month, has pushed that decision off to March 19 so it can finalize risk evaluation and mitigation strategies to improve the treatment’s safety.

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

[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.

[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.

[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.

[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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