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Today's Rundown

Featured Story

Merck takes $170M charge on abandoned COVID-19 drug

Merck has recorded a $170 million charge related to the discontinuation of the COVID-19 candidate it acquired in the takeover of OncoImmune. The action means Merck has taken hundreds of millions of dollars in charges on failed COVID-19 bets in recent months.

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Top Stories

Novavax shares in the red after vaccine sees 51% efficacy against South African COVID variant

While the world (and the biotech’s investors) wait for full data and possible filing for emergency use of Novavax’s NVX-CoV2373, it has dropped more data on how its shot works against a particular variant.

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Bluebird names oncology spinoff, establishes leadership team

Bluebird bio has disclosed the name of its oncology spinoff: 2seventy bio. The spinoff is taking cancer therapies and some executives, including the CEO and chief scientific officer, from bluebird.

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Sponsored: Mitotech brings novel approach to treating eye disorders

Mitotech focuses its clinical development efforts on ophthalmology, hoping to deliver its mitochondria targeted therapies to patients suffering from age-related as well as rare genetic eye diseases.

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Sanofi kicks off new immunology research journey with Stanford pact

Sanofi has signed a new scientific exchange pact with Stanford Medical to research three areas of immunology as part of the French pharma's pivot from the diabetes and cardiovascular disease areas.

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Sponsored: Risk Mitigation in Direct-to-Patient Clinical Trials

The COVID-19 pandemic has made society very aware of the need to be flexible in the approach to daily life. Use and acceptance of DTP has grown due to the pandemic, and sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes.

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Dyno grabs $100M to expand tech, build team, ink more gene therapy partnerships

Dyno Therapeutics emerged last year with a modest seed round and Big Pharma partnerships to fuel its work designing new and improved viral vectors to deliver gene therapy. Now, the company is kicking it up a notch with a $100 million financing to expand its platform into new tissues, build its team and ink more partnerships.

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Biden admin backs proposal to suspend intellectual property on COVID-19 vaccines, angering industry

Bucking the pharma industry on the closely watched issue of patent rights for COVID-19 vaccines, the Biden administration came out in favor of a proposal at the World Trade Organization to suspend intellectual property protections for pandemic shots.

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Medtronic debuts virtual spinal cord stimulation treatment guide

The CareGuidePro program allows healthcare providers to help manage and personalize therapy by collecting real-time feedback.

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A cancer vaccine built from stem cells? Stanford candidate shows promise in pancreatic tumors

A team at Stanford University showed that a cancer vaccine made from induced pluripotent stem cells, together with an immune adjuvant, could protect against pancreatic cancer in mouse models. It induced strong T-cell and antibody responses while dialing down immune suppressor cells.

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Resources

Guide: How to Establish a Successful Clinical Data Standards Program

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.

Whitepaper: Unlocking the True Value of Digital Therapeutics Through Partnerships

As clinical treatment options become more patient-centric, digital therapeutics provide forward-looking biopharma players the opportunity to augment the value of their offerings to stakeholders.

Whitepaper: The Journey to a Global Modular Content Strategy

One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster.

E-Book: 7 Keys to Success in Europe

This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe.

Executive Brief: Seven Secrets to Patient Experience Breakthroughs: Improving the Patient Experience and Study Retention

The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients.

Article: Make the right move at every step of the drug commercialization process

Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success.

eBook: The New Standard: Virtual Study Training in Clinical Trials

The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today.

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

Whitepaper: COVID-19 Survey report: The Lasting Impact on Outsourcing Decisions

How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond?

Content Hub: Emerging Biotech Resource Center

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

Whitepaper: Roche to pick up GenMark Diagnostics in $1.8B infectious disease testing deal

Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously.

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. 

Whitepaper: New Data: A Better Way to Run CHO Cell Culture Experiments

Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly.

Whitepaper: Overcoming the hurdles of Real-World Data Access through a federated global network

Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights.

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.

Executive Summary: Manufacturing Strategies to Effectively Industrialize Autologous Cell Therapies

Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

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.

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.

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