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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

Good news from Pfizer and BioNTech spread across the world this week, with early COVID-19 vaccine data showing 90% effectiveness. And though that could drop as studies continue, it’s still far ahead of the 50% bar the FDA said any shot would have to clear. But the mRNA-based vaccine’s cold chain needs—stored at a brisk 94° F below zero—could hamper a global rollout, and Sanofi, GSK, J&J and Novavax are waiting in the wings with their doses that can survive in a common refrigerator. Those stories plus 10 Chinese biotechs to keep your eye on, and the rest of our top reads of the week, follow below.

Featured Story

Pfizer, BioNTech see stock, hope soar as they say COVID-19 vax 90% effective, plot November EUA

Pfizer and German mRNA biotech partner BioNTech have released an early look at their experimental pandemic vaccine, and the news is good.

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Top Stories Of The Week

Pfizer's COVID-19 vaccine looks impressive, but Sanofi, J&J and Novavax shots eye a logistics edge

Pfizer's COVID-19 vaccine this week set high efficacy expectations, but the vaccine has stringent storage needs and requires two doses, creating significant challenges for a massive vaccination campaign. If they prove themselves in the clinic, later-arriving shots from the likes of Sanofi, J&J and Novavax may be better suited for global distribution.

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Special Report—10 biotechs to know in China

China has witnessed a biotech boom over the past decade, and the first crop just started to bear fruit. Here, we spotlight 10 companies that we think everyone who takes an interest in China’s biotech industry should know about since they'll likely compete on the global stage one day. What sets them apart is that all but one of them have attracted foreign Big Pharma companies buying into their R&D.

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FDA panel slams Biogen's controversial Alzheimer's med

Biogen shocked the biopharma world last year when it resurrected its once-failed Alzheimer’s drug based on findings from a post hoc analysis. But its hopes for a speedy FDA nod look dashed as a panel of outside experts picked apart the data supporting the new drug application, panning it in multiple votes.

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FDA reputation takes another hit after scathing aducanumab advisory panel meeting

It's been a tough year for the FDA's reputation already, and Friday's advisory committee meeting for Biogen's aducanumab just made it worse. The outside experts slammed FDA for its rose-colored-glasses view of the Alzheimer's candidate—and even as the panel gave the drug a resounding "no" vote, the fallout continued in public.

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Lucky Pfizer CEO Bourla cashes out $5.6M worth of stock—perfectly legally—as COVID vaccine data lifts market

On Monday, the same day that Pfizer announced that its COVID-19 vaccine was 90% effective in a clinical trial, CEO Albert Bourla sold 132,508 shares in a transaction that was set up months ago. It was the latest stroke of good fortune for a CEO who has already seen his pay skyrocket on R&D successes.

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Pfizer faces DOJ, SEC foreign bribery probes for China, Russia operations

Big Pharma's operations abroad are a common punching bag for U.S. anti-corruption watchdogs, which have snared a series of high-profile settlements in recent years. Now, Pfizer will take its turn under those watchdogs' withering eyes for its business in Russia and China. 

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FDA greenlights first diagnostic test for COVID-19 antibodies that block the virus from entering cells

The diagnostic developed by GenScript is designed to provide a test result within one hour.

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Decibel scores $82M to push hearing loss gene therapy into the clinic

Launched in 2015 to tackle hearing loss broadly, Decibel Therapeutics kicked off 2020 with a new CEO and an R&D makeover. Now it’s grabbing $82 million to propel its lead programs, including a gene therapy for children with congenital deafness and a program left over from its early days designed to protect hearing in cancer patients undergoing chemotherapy.

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Merck scraps Keytruda lung cancer trial adding Bristol Myers' Yervoy. What about the Opdivo combo?

Merck’s Keytruda is without doubt the king in previously untreated non-small cell lung cancer, but the company wanted to see whether adding another immuno-oncology agent from rival Bristol Myers Squibb would offer additional benefit. Turns out, doing that adds more harm and no good.

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Attacking pancreatic cancer with a novel immuno-oncology drug conjugate

Researchers at Boston Children’s Hospital engineered an antibody-drug conjugate to home in on pancreatic tumors and deliver a cancer-killing compound to them. Two doses of the drug shrank tumors and prevented metastasis in mouse models of the disease.

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FDA clears Apple Watch sleep app that intervenes to stop nightmares caused by PTSD

The FDA has cleared an app for the Apple Watch to help people suffering from nightmares or post-traumatic stress disorder get a better night’s sleep.

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Resources

Whitepaper: How sites can navigate the COVID bandwidth crunch

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

Research Report: 2020 North America Customer Reference Data Survey

One sentence that will be displayed in the newsletter and should be written to grab the interest of your audience to want to read more.

eBook: Mass Spectrometry-based Host Cell Protein Analysis in Biologics Development

Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics.

Whitepaper: Defining A New Standard of Care: Leading Change from the Front Line

With COVID-19 as the catalyst, empowered clinician leaders are creating solutions to challenges they face every day. Get white paper.

Webinar: Using SPOT™ & CHO-BC® During Cell Line Development for Titers up to 9 g/L

Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards.

Infographic: Reducing Time to Clinic for Your Biomedical Applications

This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments.

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: 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: 6 API Challenges That Could Slow Your Development & How to Avoid Them

One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline.

Whitepaper: Rapid BYOD Build Timelines

This white paper covers a Phase III case study; BYOD advantages and misconceptions; and regulatory, copyright, and equivalency considerations.

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: 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.

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.

Presentation: Flexible Manufacturing Strategies

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

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.

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.