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Today's Rundown

Featured Story

AstraZeneca tipped to restart COVID-19 vaccine trial this week: report

AstraZeneca could resume the U.S. clinical trial of its COVID-19 vaccine this week, according to a Reuters report. The trial has been paused since early September while the FDA reviews the safety of the vaccine in light of a reported case of a rare spinal inflammatory disorder in the wider program.

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Top Stories

Biogen finally culls MS dud opicinumab, adds SMA gene therapy to the garbage heap

Biogen is cutting its experimental multiple sclerosis drug opicinumab as well as an spinal muscular atrophy candidate amid a third-quarter clear-out.

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CRISPR stock slides as CAR-T death overshadows signs of efficacy

One of the first 11 patients to receive CRISPR Therapeutics’ anti-CD19 allogeneic CAR-T cell therapy has died. The patient was hospitalized with febrile neutropenia in the weeks after receiving the drug and died 52 days post-treatment with the CAR-T therapy.

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GSK sees 'robust immune response' from RSV vaccine hopefuls

Cold viruses often don’t get much of a look when it comes to R&D; they are annoyances, but ones that usually make us feel miserable for a few days, then clear up.

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Anatomy of a deal: How Myokardia got BMS to bump up its buyout to $13B

MyoKardia wasn’t looking for a buyout when it started discussing potential partnerships with Bristol Myers Squibb last year. But when the Big Pharma came knocking in September to ink a quick acquisition, the biotech’s executives made sure they wrung as much as they could out of the deal.

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SparingVision raises €44.5M to develop mutation-agnostic gene therapy

SparingVision has raised €44.5 million ($52.5 million) to develop its mutation-agnostic gene therapy treatment for retinitis pigmentosa (RP). The financing positions SparingVision to fund clinical trials of an AAV gene therapy that could stop vision deterioration in the 2 million RP patients.

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BridgeBio, with 21 programs underway, keeps an eye out for more prospects in new academic deals

BridgeBio Pharma may be gearing up for its first approvals, but it’s not taking its foot off the gas in early-stage research. The company inked a pair of R&D deals with the University of Colorado and the Salk Institute—its third and fourth academic collaborations of the year.

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InCarda raises $30M to reimagine afib treatment with drug-device combo

The drug that treats atrial fibrillation, flecainide, has been around since the '80s. Grace Colón, CEO of InCarda, thinks it needs a face-lift. With a $30 million initial round of series C financing led by Innoviva and existing investors Deerfield Management, HealthCap and Morningside Ventures, InCardia is hoping to make flecainide available as an at-home inhalable treatment.

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One pandemic, $2 billion, 3 months: Top COVID-19 player Thermo Fisher posts hefty Q3 revenue

As a top producer of diagnostic test kits, laboratory hardware and supplies, Thermo Fisher Scientific has been a major player in the global response to the COVID-19 pandemic almost from the start—and now, the company has shown exactly how major.

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Inhaled antibody drug for COVID-19 clears coronavirus in animals

An inhaled neutralizing antibody cleared the novel coronavirus from infected hamsters at a far lower dose compared with other experimental monoclonal antibodies. The drug is now being developed by Aridis Pharmaceuticals and could offer a self-administered option for COVID-19 if it succeeds in human testing.

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Resources

eBook: Navigating the Insulin Affordability Act

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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

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Whitepaper: Exploring the patient dynamic from different perspectives

The culture of clinical research is evolving from one directed by researchers to one driven by the needs of patients and those who care for them.

Whitepaper: High Content Screening in 3D: Faster 3D Image & Multi-Parametric Data Analysis

Creating integrated HCS workflows in a single platform increases accuracy; reduces time and helps to identify the most appropriate hits or drug candidates. Learn more about a reliable method for creating a more efficient, faster, 3D image and multi-parametric data analysis workflow.

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.

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An integrated compliance model can be the competitive differentiator to commercialization and move the needle from cost center to value. Learn How.

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: Position Your Pharmaceutical Lab for Success

Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions.

Whitepaper: Technology Transfers: Reaping Rewards, Reducing Risks

Learn how to safeguard supply, improve distribution and reduce program costs and risks

Whitepaper: Making Data Central to Your CNS and Pain Trials

Learn how the right data capture solution can prompt the patient to follow the correct procedures and automatically sort the responses, according to protocol.

Whitepaper: Research Reveals New Launch Standards for First-to-launch Pharma and Biotech Companies

While COVID-19 has shifted the rules of the healthcare industry, research shows there was already progress on changes being made for how pharma companies are launching products.

Whitepaper: 16 Biopharma Leaders Tell How COVID-19 Will Change Customer Engagement

Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers.

Report: State of Life Sciences | 2020 Trends Report

A complete Life Science Industry Snapshot in One Report

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