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Today's Rundown

Featured Story

J&J seeks European approval for twice-yearly schizophrenia drug

Johnson & Johnson has filed for European approval of a six-month injectable version of its schizophrenia drug Invega. J&J is seeking approval for the longer-acting injectable on the strength of data showing it is as effective as the existing three-month formulation.

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Top Stories

ShapeTX claims breakthrough in tissue-specific gene therapies

Shape Therapeutics has unveiled a capsid discovery platform designed to improve the delivery and safety of gene therapies. The platform is designed to generate adeno-associated virus (AAV) vectors that home in on specific tissues, thereby enabling gene therapy developers to achieve the desired effect without causing intolerable toxicity.

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FDA lets Toralgen's insulin-delivering nanopill into tech scheme

The FDA has accepted Toralgen’s polybile nanopill into its Emerging Technology Program. Getting into the program sets Toralgen up to meet with the FDA’s emerging technology team to resolve potential technical and regulatory issues that could slow the progress of its nanopill.

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Lexaria posts data on enhancing oral antiviral delivery

Lexaria Bioscience has released preclinical data on technology intended to enhance oral delivery of antiviral drugs. The data cover the use of application of DehydraTECH to HIV drugs, but Lexaria is also exploring its use in the enhancement of antivirals against the pandemic coronavirus. 

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ASH: Johnson & Johnson shores up Darzalex's myeloma lead with another subcutaneous win

With Sanofi’s Sarclisa hitting multiple myeloma star Darzalex with its first in-class competition, Johnson & Johnson is working to convert patients to a newer, more convenient subcutaneous version of the med. And some new data just gave that mission a boost.

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The top 10 manufacturers in the fight against COVID-19

Given the enormous manufacturing challenges posed by COVID-19, big biopharma players have increasingly leaned on contract manufacturers to help out. In anticipation of what could be multiple successful COVID-19 vaccines in the near future, Fierce Pharma has assembled its list of the top 10 contract manufacturers in the fight against COVID-19.

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Resources

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.

Research Report: 2020 North America Customer Reference Data Survey

New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress.

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.

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