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Today's Rundown

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Novavax pledges to help verify COVID vaccine status for trial participants as the world opens back up to travel

As debate about COVID-19 vaccine passports continues, participants in clinical trials for shots that are yet to be authorized are finding themselves lost in the shuffle. Novavax, which is trying to get its vaccine across the finish line, spoke up Wednesday to say that clinical trial participants should not be disadvantaged in situations where they need to provide proof of vaccination.

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Top Stories

UPDATE: Roche dismisses early filing chatter for its Alzheimer’s drug as speculation, remains focused on phase 3 trial

An analyst report stating that Roche will seek early FDA approval for its Alzheimer’s disease candidate gantenerumab appears to have jumped the gun, according to comments from the Swiss pharma giant. Jefferies stated in a research note that the Swiss Big Pharma had met with FDA regulators last week and would be following in Eli Lilly's footsteps to file the candidate under an accelerated review pathway. 

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CureVac looks to subgroup to save failed COVID-19 vaccine as final analysis confirms sub-50% efficacy

CureVac has highlighted the efficacy of its failed COVID-19 vaccine in adults aged up to 60 years as evidence the jab has a role to play in the response to the pandemic. The German biotech is pushing ahead with a regulatory submission in Europe despite achieving 48% efficacy in its phase 2b/3 trial.

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Sponsored: The Far-Reaching Value of Deeply Understanding the Patient Journey

An experiential learning program where Alexion employees “walk in the shoes” of patients to deepen understanding of the rare disease journey and develop impactful solutions. Learn more about LEAP.

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Nestlé doubles down on Seres partnership, ponying up $175M for rights to C. diff treatment

After a rough couple of years, things are looking up for Seres Therapeutics. The microbiome company’s partner Nestlé Health Sciences is handing over $175 million upfront to help market its lead microbiome treatment in North America.

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Aditum's 5th biotech will take another look at Taisho's failed depression drug

The investment firm Aditum is launching Ancora Bio with the exclusive rights to Taisho Pharmaceutical's depression drug candidate that last year fell short in a clinical trial. Ancora believes a fresh set of eyes could make the difference.

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Apellis, Beam ink $75M deal to bring gene-editing meds to complement diseases

While a couple companies are making waves in gene editing, Beam Therapeutics is swimming in a different direction with the budding technology to help reset the immune system. The company is joining forces with Apellis Pharmaceuticals to create new gene-editing treatments for complement-driven diseases, a broad bucket of ailments caused by an overactive part of the immune system. 

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Roche confirms it could cut 300 to 400 product development jobs

The Swiss Big Pharma is looking at a "new prioritisation" and will likely make the cuts in its clinical development workforce, a Roche spokesperson confirmed.

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Former Sanofi executive joins low price-focused biotech EQRx to lead drug creation

Carlos Garcia-Echeverria, Ph.D., was global head of research platforms at Sanofi and now takes the helm of drug discovery for EQRx, which has gained $750 million since January 2020 to advance its portfolio.

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Elliott fires opening salvo at GlaxoSmithKline, calling for new management to fix 'severe underperformance'

After months of plotting in secret, Elliott Management has finally made its intentions around GlaxoSmithKline known. The activist investment group is calling for drastic changes at the drugmaker to salvage GSK from what it called “years of under-management.”

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Cambridge researchers pinpoint antimalarial, arthritis drugs for COVID-19 repurposing

By using computational analyses, scientists at the University of Cambridge have identified 200 approved drugs as possible candidates for repurposing against COVID-19 and validated two of them in early tests. Given that both drugs are well-established, they should be rapidly advanced into clinical trials to test whether they can prevent or treat the virus, the researchers proposed.

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Hospital CEOs stayed in place during a hectic year for health systems

Nationwide hospital CEO turnover dipped for a second consecutive year to match the lowest rates seen in a decade, according to a recent American College of Healthcare Executives report.

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ASCO and Friends push for more cancer patients in COVID-19 vaccine trials

A larger portion of cancer patients needs to be included in COVID-19 vaccine trials to gain better understanding of the safety and efficacy for the demographic that is more susceptible to the SARS-CoV-2 virus, argue the American Society of Clinical Oncology and Friends of Cancer Research.

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Resources

Whitepaper: Strategies for mitigating supply chain risk in clinical trials

Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget.

Whitepaper: Evaluating current manufacturing platforms for recombinant AAV production

Choose the right AAV platform for your viral vector-based therapy

E-Book: Digital Therapeutics 101

E-book to get newcomers “up to speed” quickly on digital health and digital therapeutics while also addressing key issues important to those already familiar with the topic.

Whitepaper: To De-Risk Your Next Trial, Seek Outside Expertise

Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions.

Report: Cell & Gene Therapy in 2040: Seizing the moment to propel the industry forward

What does the future of Cell & Gene Therapy look like?

Whitepaper: How to Launch a Successful BYOD Strategy in Any Phase

For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink.

eBook: Improving Diversity and Inclusion in Clinical Trials

Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them.

Whitepaper: Closed Cell Processing System Benefits for Cell & Gene Therapy

Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process.

Guide: Your Guide to Overcome Inconsistent Clinical Data Standards

Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials.

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.

Content Hub: Process Intensification Resource Center

A one-stop hub for Cytiva resources to support process intesification

Content Hub: Emerging Biotech Resource Center

A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule

Content Hub: Remarque Systems Resource Hub

Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 

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: 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.

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