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May 13, 2020___

Today's Rundown

Featured Story

Pfizer, BioNTech to ramp up COVID-19 vaccine tests, plot major trial boost in fall

U.S. Big Pharma Pfizer and German biotech partner BioNTech are looking to ramp up trials of its vaccines against COVID-19 with a major scaled-up test plotted for the fall.

Top Stories

Sunovion ditches once-rejected ADHD, binge eating program

Sunovion Pharma is calling it quits on dasotraline, a dopamine and norepinephrine reuptake inhibitor it was developing for binge eating disorder and attention deficit hyperactivity disorder (ADHD). It withdrew New Drug Applications for both indications and stopped development of the program.

Wellcome Leap nabs $300M, ex-DARPA, Illumina execs to battle global health problems

The U.K.’s Wellcome Trust has spun out a new nonprofit with a hefty seed fund and some big names to battle against “the most pressing global health challenges of our time.”

[Sponsored] The COVID-19 crisis: Five ways pharmaceutical leaders can rise to the challenge

Amid the COVID-19 crisis, Takeda leaders share five ways to adjust to protect people’s families, colleagues and community, while maintaining a commitment to the people who need Takeda’s medicines.

Avrobio posts 22-month update on Fabry gene therapy trial

Avrobio has provided interim data from a phase 2 trial of its Fabry disease gene therapy AVR-RD-01. The update shows the positive effects on biomarkers seen early in the trial have now persisted for up to 22 months, leading Avrobio to talk up the durability of its one-time treatment.

QurAlis nabs $42M funding round for ALS, frontotemporal dementia

QurAlis has officially launched under a $42 million series A round with a focus on new therapies for amyotrophic lateral sclerosis and genetically related frontotemporal dementia.

LabCorp, Quest broaden availability of COVID-19 tests nationwide

The U.S. clinical testing giants Quest Diagnostics and LabCorp are broadening the availability of their COVID-19 diagnostic tests, opening up their use nationwide.

Gilead inks deals with generics makers to supply COVID-19 therapy remdesivir for 127 countries

After scoring an early authorization for its COVID-19 therapy remdesivir, Gilead Sciences has been on the hunt for manufacturing partners to help boost production for the in-demand drug. Through a series of licensing agreements, Gilead has taken the first steps to build that network. 

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] The great data transition: Making the move from claims to EHR data

The immediacy of EHR data availability can be significantly impactful, particularly as the health care system works to address COVID-19. Download this whitepaper to learn more.

[Whitepaper] Continuous Manufacturing vs Batch: Deciding on the Best Solution for your Oral Solid Dose Product

Continuous Manufacturing vs. Batch for Oral Solid Dose

[Whitepaper] Flexible Design for Novel Trials

Download this case study to read about how Cenduit navigated these challenges, and successfully supports the trial sponsor to execute the umbrella trial with agility.

[Whitepaper] Critical API Attributes and the Major Impact They Can Have on Drug Product Development

Download this whitepaper to learn more about the importance of an integrated approach to formulation.

[Case Study] More Powerful Analytics Capabilities

Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI.

[Case Study] Precision Analytics for Product Launch and Growth

Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights. 

[Whitepaper] Is Wurster Processing the Right Choice for My Multiparticulate Modified Release Dosage Form?

Wurster processing is a versatile technique for developing and manufacturing multiparticulates for modified release dosage forms. Read this whitepaper to determine whether Wurster processing is the right option for your project.

[Webinar] Chemistry Through Biology: Translating Molecular Biology Technologies into Practical Processes for API Production

In this webinar, the featured speaker will explore the key advances and critical hurdles for translating these emerging molecular biology technologies into real-world applications and commercial processes.

[Whitepaper] Assessing the Financial Impact of Translational Pharmaceutics®

Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug. Download the whitepaper.

[Magazine] Perspective: the patient edition

Report: Think you’re patient-centric? Think again. Find out how patients really feel about patient-centricity. Learn what they would like to experience along with tools and tips for maximising patient engagement across the product life cycle¬ – from clinical trials to service design and creative campaigns.

[Whitepaper] New Lonza Whitepaper on Modulating lgG Effector Function

This whitepaper summarises approaches for modulating antibody effector functions and pharmacokinetics, and provides examples of antibodies in clinical studies.

[GUIDE] Managing Clinical Trial Patient & Site Engagement During COVID-19

Leverage strategic solutions to respond to immediate challenges to patient and site engagement from COVID-19, and learn to maximize the FDA guidance on the conduct of clinical trials during a pandemic.

[Guide] Pandemic Survival Guide --- IT Solutions for Business Continuity

To survive in these challenging conditions, companies need to promptly address business continuity issues - especially the remote delivery of data and voice solutions. See how Outer Edge can help.

[Whitepaper] Ensuring the Greatest Return From Your Poorly Soluble Molecule

Poorly soluble molecules hindering your workflow?

[On Demand] Tufts-eClinical Solutions Data & Analytics Survey Results

Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor.

[eBook] Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study.

[Fact Sheet] Forecasting to Optimize Clinical Trial Supply Management

Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study.

[Case Study] Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

[Executive Summary] Strategies for Flexible Manufacturing

This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market.

[Presentation] Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

[Executive Summary] Overcoming Manufacturing Challenges for Accelerated Drug Development

Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project.

Events