To view this email as a web page, click here

Today's Rundown

Featured Story

Data for Biogen's Alzheimer's hopeful aducanumab 'highly persuasive': FDA briefing documents

A drug that was very nearly culled and needed some serious data digging to find glimmers of efficacy has been broadly backed as “highly persuasive” from the FDA’s briefing documents out Wednesday morning.

read more

Top Stories

Trial chief tips AstraZeneca COVID-19 vaccine for 2020 data drop

AstraZeneca has a good chance of delivering late-phase data on its COVID-19 vaccine this year, the chief investigator of the Oxford Vaccine Trial said. The timing gives AstraZeneca a “small chance” of being able to start distributing the AZD1222 vaccine in the U.K. before Christmas.

read more

Fosun follows BioNTech in changing COVID-19 vaccine, plans bridging study for Chinese filing

Fosun Pharma has stopped development of BioNTech’s first COVID-19 vaccine, following the lead of its German partner by picking BNT162b2 as the candidate to take to market. 

read more

Sponsored: Best Practices for Research Sites: Effectively Using Patient Recruitment Advertising Dollars

Are you looking to optimize your site’s patient recruitment advertising dollars? WCG’s experienced team of patient recruitment experts can help your site efficiently use your advertising funds by creating customized recruitment campaigns for any of your studies, and we’ve also curated a list of best practices to ensure your spend sees the best ROI.

read more

JW Therapeutics rakes in $300M Hong Kong IPO to bring CAR-Ts to China

As it gears up to launch a new CAR-T therapy in China, JW Therapeutics pulled off a $300 million (HK$2.325 billion) IPO on the Hong Kong Stock Exchange. The bulk of the funds will bankroll R&D and commercialization for its lead program, while the rest will fund the company’s earlier-stage programs.

read more

BioMarin nabs FDA review for dwarfism drug vosoritide, forgoes AdComm as it eyes 2021 approval

The FDA will hand down a decision on BioMarin’s rare disease drug vosoritide by Aug. 21 as it says there's no need for an advisory committee.

read more

Inhibikase Therapeutics slahes deal size ahead of IPO

Twelve-year-old early-stage neuro biotech Inhibikase Therapeutics has nearly halved its shares offering ahead of a now lowered IPO.

read more

FDA greenlights Boston Scientific's paclitaxel-coated Ranger balloon for peripheral artery disease

Boston Scientific has secured FDA approval for its Ranger paclitaxel-coated balloon, designed to help limit a patient’s systemic exposure to the chemotherapy used to slow the closure of reopened arteries.

read more

Resources

eBook: THE NEED FOR TRIAL VIRTUALIZATION

Responding to site challenges. Approaching virtualization. Leveraging real-time data. Medidata shares 8 parameters to implement your virtualization strategy during COVID-19 and beyond. Download Now.

Whitepaper: CRCs Equip Sites to Navigate the New Normal

Need additional site resources for your current or upcoming clinical trial?

Q&A: The Road to a COVID 19 Treatment Launch

How pharma's supply chain partners are paving the way for coronavirus therapies.

Whitepaper: Liquid-Filled Capsules for Highly Potent Drug Compounds

Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives.

Whitepaper: Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation

Anticipate early development challenges to avoid rework and costs.

Article: Strategies to address the viral vector manufacturing shortage

Accelerating the production of viral-vector based therapy requires both understanding of strategies to address viral vector manufacturing and how to select the most cost-effective solution for your therapeutic. Read more in this article.

Whitepaper: How to Leverage IDN Data – Everything You Need to Know

Get insights into healthcare decision-makers networks.

Webinar: Elevate Your Digital Events Strategy

Learn how to plan immersive digital event experiences

Whitepaper: Gene and Cell Therapy: Planning for Manufacturing Success Early

Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience.

Whitepaper: COVID-19 Vaccine Clinical Trials in Children: Challenges on the Horizon

Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper

Whitepaper: Companies Need An Effective Remote Workforce Cloud Strategy To Survive

A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Whitepaper: Go from Process R&D to Clinical APIs Quickly and Effectively

Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success.

Q&A: Planning Successful Launches

Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools.

eBook: CMC Considerations for Successful Early Drug Development

This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success.

Webinar: Phase Appropriate Expertise and Technologies to Accelerate Product Development to Commercialization

In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site.

Whitepaper: How to Achieve Time and Cost Reductions in Clinical Trial Design and Build

Learn how to save time and reduce costs and complexity by streamlining the clinical trial process.

Whitepaper: Why Your Business Needs a Ransomware Strategy To Avoid Being Hacked!

Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now!

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Executive Summary: Keys to a Successful Rapid Commercial Launch

Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

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.

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.

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.

Events