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Today's Rundown

Featured Story

Patient death casts a shadow on AstraZeneca's COVID-19 trial: report

A patient has died in the global study of AstraZeneca’s COVID-19 vaccine, Brazil’s health authority, Anvisa, announced on Wednesday. Despite the death, the study will carry on as normal, Reuters said.

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Top Stories

Roche to pay Atea $350M for ex-U.S. rights to COVID-19 antiviral

Roche is paying Atea Pharmaceuticals $350 million upfront for the ex-U.S. rights to COVID-19 antiviral AT-527. The oral direct-acting antiviral is set to enter a phase 3 trial in non-hospitalized patients early next year, giving Roche and Atea a shot at establishing it as the go-to early treatment for COVID-19.

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Fresh from early successes, RA Capital bags $461M for new fund

RA Capital Management has raised another $461 million to invest in private biotechs. The closing of the fund comes 15 months after RA Capital set up an inaugural venture fund that has already seen 25% of its portfolio companies IPO or be acquired. 

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Pandemic vaccine programs cannot tell us whether they will save lives: Doshi

Highly respected Professor Peter Doshi has penned an opinion piece in the BMJ pointing out that current COVID-9 vaccine tests are not set up to tell us whether they can save lives.

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Pfizer snaps up antibiotics maker Arixa and its oral Avycaz follow-up

This summer, Pfizer teamed up with other Big Pharmas on a $1 billion fund to bolster struggling antibiotics makers. Now, the company is adding a new antibiotic candidate to its pipeline through its acquisition of Arixa. If approved, the prospect could be the first new drug of its kind in more than 35 years.

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Be Biopharma debuts with $52M to advance engineered B-cell therapies

You may have heard of T cells before, but Aleks Radovic-Moreno, Be Biopharma’s co-founder, president and director, is betting on B cells as the future of cell therapies.

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New CEO, major Roche biobucks pact: Now, Rheos nabs ex-Biogen R&D exec as CSO

Dania Rabah, Ph.D., has become the new chief scientific officer at startup Rheos Medicines, coming off a stint as the head of the drug discovery incubator, research and early development at Biogen.

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Azura Ophthalmics bags $20M to tackle root cause of dry eye

Doctors may prescribe steroids or eye drops for patients with dry eye disease. But Azura Ophthalmics wants to do one better with a drug that tackles the root cause of the disease. To that end, it’s raised $20 million, which will bankroll a pivotal trial in the first quarter of 2021.

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Quest Diagnostics ups guidance, notches major sales growth and gives back CARES Act cash

There are many companies losing out over the economic impact of the pandemic, but Quest Diagnostics is one that is booming as a result.

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How a drug derived from antiparasitic might combat blood cancer

Scientists at the University of Alberta have found that a new drug derived from antiparasitic compound could kill off blood cancer in mice by targeting a survival-related signaling pathway in B cells. A startup called Pacylex Pharmaceuticals is gearing up for a phase 1 trial later this year.

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Resources

Whitepaper: Patient Affordability Legislation: How This Frontier in the Pharmaceuticals Industry May Shape Your Business

This white paper outlines how one such law, Minnesota’s Alec Smith Insulin Affordability Act, has impacted the pharmaceutical industry and provides guidance about strategies businesses can employ to rapidly add support.

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

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.

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.

Whitepaper: COMPLIANCE –THE COMPETITIVE DIFFERENTIATOR TO COMMERCIALIZATION: An Integrated Model Setting the New Global Standard

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