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Today's Rundown

Featured Story

ImmunityBio shares data on oral COVID-19 vaccine, plans phase 1

The pairing of a subcutaneous prime shot with two oral boosters protected nonhuman primates against the coronavirus, setting Patrick Soon-Shiong’s ImmunityBio up to expand its clinical development program.

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Top Stories

EMA backs Xeris' ready-to-use glucagon for approval, setting up showdown with Novo and Lilly

Xeris Pharmaceuticals has taken a big step toward receiving approval for its ready-to-use formulation of glucagon in the EU. The injectable formulation, branded Ogluo, received a positive opinion from the European Medicines Agency’s drug review committee. 

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Altimmune starts testing long-acting rival to AstraZeneca NASH drug

Altimmune has begun a phase 1 clinical trial of its long-acting nonalcoholic steatohepatitis drug ALT-801. The asset, like AstraZeneca’s more advanced cotadutide, is a GLP-1/glucagon receptor dual agonist, but it has a less-frequent dosing schedule and potentially superior tolerability.

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Antibody-directed microbubbles touted as targeted cancer therapy

Researchers have presented preclinical data on the use of antibody-directed microbubbles to get cytotoxic payloads to tumors. The payload remains encapsulated until an ultrasound pulse bursts the bubbles and triggers the release of the therapeutic.

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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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Rani Therapeutics nets $69M to transform injections into its easy-to-swallow 'robotic pill'

Rani Therapeutics has secured $69 million in new funding to move forward with the manufacturing and clinical testing of its “robotic pill”—a small, swallowable capsule that promises to shepherd more delicate drugs past the stomach before releasing them into the bloodstream.

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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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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.

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.

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: 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.

Events