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February 15, 2019

Editor’s Note: FierceBiotech will not publish on Monday next week due to the Presidents Day holiday, but we’ll be back in your inbox on Tuesday, Feb. 19.


Today's Rundown

Featured Story

FDA funding set to jump as Congress votes to avert shutdown

Congress has approved a budget deal to avert another government shutdown. The deal, which is due to be signed into law by President Trump, includes the biggest increase in FDA funding in several years.

Top Stories

Nimbus brings on Janssen discovery head as CSO with plans to expand its portfolio

Digital drug miner Nimbus Therapeutics has brought on Janssen’s global head of lead discovery, Peter Tummino, Ph.D., to serve as its chief scientific officer.

India’s Glenmark spins out NMEs into U.S. company

India’s Glenmark is rolling all of the new molecular entities (NMEs) in its pipeline into a separate U.S. company in an effort to speed the programs to market.

[Sponsored] Invert to Convert: Rethinking Patient Recruitment & Enrollment Strategies

90% of clinical trials will meet their enrollment goals if their original timelines are doubled. WCG breaks down the barriers to ramping up and meeting patient enrollment goals. A new approach addresses root causes and accelerates study timelines by 33%.

TCR2 IPO hits midpoint, setting stage for trials of CAR-T rivals

TCR2 Therapeutics has priced its IPO at the midpoint of the target range. The offering stands to net TCR2 $67 million, setting it up to move cell therapies designed to better CAR-Ts through early-phase development. 

Passage Bio to tackle CNS diseases with $115M and UPenn gene therapy programs

Passage Bio reeled in a $115.5 million series A on Thursday, which will support the development of five programs aimed at treating rare monogenic central nervous system (CNS) diseases. Passage Bio is working on those five under a research, collaboration and license agreement with the University of Pennsylvania.

EuroBiotech Report—AstraZeneca clear-out, uniQure data, Grey Wolf, Pathios and CureVac

In this week's EuroBiotech Report, AstraZeneca clears out cancer projects, uniQure's hemophilia B drug clears another test and Grey Wolf raises £10 million.

FiercePharmaAsia—AstraZeneca’s China business; Pfizer Japan valsartan recall; Xofluza resistance

AstraZeneca's China business soared 25% in 2018 as cancer and respiratory drugs pulled through; Pfizer Japan is recalling valsartan combo drugs made using Mylan's tainted API; Japanese doctors recorded resistance to Shionogi and Roche's novel flu drug Xofluza; and more.

Chutes & Ladders—Sanofi's CMO takes on chief digital officer role

Sanofi's new chief digital officer joins executives looking to leverage tech; Parexel nabs four high-profile FDA staffers; and Nimbus brings on Janssen's discovery head as CSO. Those moves plus more hirings, firings and retirings throughout the industry.

Enrollment Showcase

Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

Resources

[Whitepaper] Better Market Intelligence With Smart Search

It’s never been more challenging to stay on top of trends and innovation shaping the future of healthcare. Discover how AI can help competitive intelligence teams achieve more proactive strategies.

[Webinar] Biostatistics for Non-Statisticians: Understanding Different Types of Analyses and When to Use Each

If commonly used statistical phrases like two-sample t-test, difference in proportions, or hazard ratio intimidate you, join this webinar for an introduction to statistical analyses in clinical trials.

[Whitepaper] Managing Demand Uncertainty in Biologics Production

When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need, factoring in its estimate of the size of future sales, the timing of the launch, the dosage of the product, its strategy for building its market and a host of other variables.

[Whitepaper] RTSM/IRT: A Roadmap For Developing Systems That Address Current Frustrations

92% of survey respondents make changes to their RTSM/IRT systems due to study changes. See what else puts a strain on their clinical trials. Download the Research Whitepaper.

[Whitepaper] Six API Challenges That could be Slowing your Development

Download this whitepaper to learn more.

[Whitepaper] Engaging Organized Customers in the Era of the Quadruple Aim

Explore how the pharma industry can adapt its approach to the changing healthcare marketplace in the era of the Quadruple Aim

[Whitepaper] Clinical Validation of a Powerful Immune Assay for Patient Selection

Learn how Health Expression Models provide increased sensitivity, specificity, and accuracy for characterizing immune response in solid tumor specimens.

[Whitepaper] Host Cell Protein Analysis in Biologic Drug Development

This whitepaper reviews fundamental aspects of HCPs that pertain to biologic drug development and presents current and emerging approaches to HCP analysis.

[Whitepaper] Integrating clinical research at the Point of Care—A New Operating Model

Clinical trials take too long and cost too much—here's what needs to change.

[POCKET GUIDE] 3 Steps To Supercharge Your Literature Search

Go from Search to Full-Text Scientific Papers in a Single Click!

[Whitepaper] Achieving launch excellence in the challenging healthcare markets of today

This white paper consists of original data and expert interviews. Download it today for exclusive tools, tips and analysis on achieving launch excellence in challenging pharma markets.

[Whitepaper] Accelerate Time To Market Working With Industry Specialist MSP

With FDA approval imminent, start-up Life Sciences company partners with an industry focused MSP to design and manage its regulated cloud-based infrastructure to speed time to market.

[Whitepaper] Liquid Biopsy Investor Toolkit

With the liquid biopsy market maturing and >80 companies still competing with liquid biopsy offerings, it is crucial for investors to be able to cut through the noise and identify the winners.

[Survey] Veeva 2019 Unified Clinical Operations Survey

Share your thoughts on the life sciences industry's progress in improving study execution.

[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.

Events