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Editor's note: This will be the last issue of Fierce Drug Delivery in 2020. We'll be on a publishing break until Jan. 6, but check our websites for breaking news in the meantime. And have a safe, happy holiday season.

Today's Rundown

Featured Story

GSK's ViiV gets EU approval for long-acting HIV injectable

ViiV Healthcare has won approval for its long-acting injectable HIV treatment Vocabria in Europe. The authorization clears ViiV to sell a drug that could reduce the number of doses patients need to take a year from 365 to six.

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Top Stories

Codagenix, Serum Institute take nasal COVID-19 vaccine into clinic

Codagenix and the Serum Institute of India have begun a first-in-human clinical trial of their single-dose intranasal COVID-19 vaccine. The partners are assessing the live attenuated candidate, COVI-VAC, in a 48-subject phase 1 clinical trial in the U.K.

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2021 forecast: Targeted delivery, oral vaccines and mRNA 2.0: The next generation of drugs and prophylactics in the fight against COVID-19

As the chapter closes on the first year of the COVID-19 pandemic, drugmakers are hard at work bolstering the defenses mounted in 2020—and they're looking at new formulations and delivery methods to bring vaccines and therapies to more people around the world.

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BARDA backs Opiant push to develop nasal opioid overdose drug

Opiant Pharmaceuticals has secured up to $3.5 million from the U.S. government to advance clinical development of its nasal opioid overdose drug OPNT003. The nasal drug delivery specialist is taking the candidate forward in the belief nalmefene has advantages over the currently used naloxone. 

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MedinCell advances long-acting COVID-19 injectable program 

MedinCell has shared phase 1 data on the continuous daily administration of ivermectin. The results are an early step in a program that could lead to the use of a long-acting injectable formulation of the molecule.

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Yea, Verily: Google's health-focused sibling secures $700M to rapidly scale up commercial work

Google’s life science-focused sibling company Verily has raised a mammoth $700 million investment round to help rapidly expand its commercial reach.

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The top 10 M&A targets in medtech

Many of our top M&A targets offer unique solutions through AI, sensors and the cloud to make medical technologies more portable, so providers can go to where the patients are and not the other way around—which may be essential as COVID-19 continues to change the landscape.

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Pharma's edition of the 2020 story, as told by Fierce readers

To look back at Fierce Pharma’s top stories of 2020 is to see the COVID-19 pandemic in miniature. The early desperation for treatments that spawned hydroxychloroquine hype. The first authorized antiviral—and the debate about its price. And the vaccine journey, from preliminary hints through the autumn's vaccine politics and beyond.

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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.

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