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Today's Rundown

Featured Story

It's official: Pfizer, BioNTech COVID-19 shot grabs emergency FDA nod, clearing way for first U.S. vaccinations

That was fast. Just over 24 hours after an FDA advisory panel recommended emergency use of Pfizer and BioNTech’s COVID-19 vaccine, the agency responded, making the candidate the first pandemic shot to score emergency use authorization in the U.S.

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Top Stories

The top 10 R&D programs laid to rest in 2020

There is a wide range of drug programs that saw the final nail in the coffin in 2020, ranging from autism, dermatitis, and dry eye disease, to respiratory, gastrointestinal, and cancer therapies. Check out their obituaries.

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Genentech pays Relay $75M for cancer drug, plans KRAS combo

Genentech has struck a deal to license Relay Therapeutics' SHP2 inhibitor for $75 million upfront. The Roche subsidiary plans to combine the drug with its KRAS G12C inhibitor, reflecting evidence targeting SHP2 counters adaptive resistance to the red-hot approach to treating cancer.

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Sponsored: Vida Ventures: Powering Breakthroughs in Biopharma

RBC Senior Biotech Analyst Luca Issi interviews Co-Founder of Vida Ventures Arjun Goyal on passion for investing, company purpose, and emerging modalities and investor trends in today’s unique market.

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CureVac starts late-phase clinical trial of COVID-19 vaccine

CureVac has begun a phase 2b/3 clinical trial of its COVID-19 vaccine candidate CVnCoV. The study will enroll 36,500 participants in Europe and Latin America with a view to generating data to support approval of the mRNA vaccine next year.

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Arvinas eyes a busy 2021 as protein degraders gather steam in breast, prostate cancers

Just in time for the holiday season, Arvinas’ lead protein degraders delivered promising early results in patients with hard-to-treat breast or prostate cancer. As the company continues those phase 1 trials, it’s gearing up for new trials in 2021, including dose-expansion and combination studies.

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Gene therapy player InnoSkel debuts with €20M for rare skeletal diseases

Elvire Gouze Ph.D., a serial entrepreneur and expert in skeletal disorders, has formed another company—InnoSkel—after agreeing to sell her first venture Therachon to Pfizer for $340 million upfront last year.

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COVID-19 nasal spray from Eureka Therapeutics protects mice against infection

The respiratory airway, as the primary entry point of the novel coronavirus, could be a good target for delivery of drugs that aim to protect people against the disease. An antibody nasal spray designed by Eureka Therapeutics protected mice against the virus for at least 10 hours, even at the lowest concentrations tested.

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AstraZeneca snaps up Alexion for $39B in a leap toward CEO's $40B revenue goal

Just when Gilead's $21 billion acquisition of Immunomedics looked to be 2020's biggest biopharma deal, AstraZeneca came up with an even larger one—and it involves one of the industry’s top takeover targets, Alexion. But one analyst argues the British pharma isn't paying enough for a "scarce and high-quality asset."

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Resources

Infographic: 6 Ways Phenotypic Data Improves Decision-Making in Your Drug Development Program

Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline.

Case Study: Aerie fuels new product launches with ZS's REVO analytics platform

Learn how Aerie fueled their product launches with advanced analytics.

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

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

Whitepaper: Enabling Fast And Appropriate Drug Product Supply for Phase 1 Clinical Trials

Lack of resources to move from lab concept to the manufacture/delivery of GMP clinical supplies to patients, key milestones can be missed.

Article: Process development and scale-up of pluripotent stem cell manufacturing

Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand.

Whitepaper: The Future of Pharmacovigilance

Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Whitepaper: Survey Reveals Demand for Clinical Trial Innovation in the Wake of COVID-19

The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement.

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.

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.

Research: Premier Research Resource Hub

Browse the latest learnings and insights from our clinical development professionals.

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.

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: 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: 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.

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: 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