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Today's Rundown

Featured Story

Merck cans both its COVID-19 vaccines due to weak clinical data 

Merck has stopped development of its two COVID-19 vaccine candidates after getting a look at phase 1 data. The vaccine powerhouse said neither candidate triggered immune responses comparable to those achieved by rival jabs, leading Merck to cut its losses and focus on COVID-19 therapeutics. 

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Thank you to Catalent for sponsoring this year's JPM 2021 coverage.

Top Stories

Roche eyes FDA filing after bispecific matches Eylea again

Roche’s bispecific faricimab has matched Regeneron’s Eylea in another pair of phase 3 clinical trials. The top-line results suggest the VEGFxAng2 bispecific antibody faricimab performs as well as Eylea in people with “wet” age-related macular degeneration even when it is dosed half as often.

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2020’s top 10 clinical trial flops

While big companies can shrug off a failure, the wasted investment and missed commercial opportunities can still be damaging. For smaller companies, flunking a trial can jeopardize the future of the business.

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Faze Medicines nabs ex-Northern Biologics chief, Shire alum as new CEO

Faze Medicines has a new CEO: Philip Vickers, Ph.D., a Shire alum who most recently led cancer-focused Northern Biologics. Vickers takes over from interim CEO Cary Pfeffer six weeks after Faze emerged with $81 million to pursue medicines targeting biomolecular condensates.

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After selling off most of the Vants, Roivant CEO Ramaswamy moves upstairs to executive chair

Roivant CEO and founder Vivek Ramaswamy is to become the biotech builder’s executive chairman as he promotes Chief Financial Officer Matt Gline to the chief’s role. There’s less to manage these days after Roivant sold off five Vants—Myovant, Urovant, Enzyvant, Altavant and Spirovant—to Sumitomo Dainippon, which now runs them under a new company, Sumitovant.

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TScan adds another $100M to the pot to as it plots new TCR cancer trials

TScan Therapeutics has raised a cool $100 million in a series C to start 2021 on the positive notes it rang throughout 2020.

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Aurinia snags FDA approval for lupus nephritis med Lupkynis, its first drug launch

Aurinia has nabbed its first FDA approval with an OK for Lupkynis (voclosporin) to treat lupus nephritis, or kidney inflammation caused by systemic lupus erythematosus. And now it'll look to its newly bolstered commercial team to take the drug into a wide-open market.

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Gut bacteria point to novel strategies for combating asthma, COVID-19

Australian researchers studied the microbiome in mouse models of asthma and were surprised to discover that the molecules L-tyrosine and p-cresol sulfate protected against lung inflammation. Now they're planning to fast-track L-tyrosine into clinical trials in asthma, and they believe it might also be effective against acute lung disease in COVID-19.

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FDA approves Boston Scientific's newest deep brain stimulator for Parkinson's disease

Boston Scientific has obtained approval from the FDA for the fourth generation of its Vercise Genus deep brain stimulation system, allowing conditional use while within an MRI scanner.

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Resources

Content Hub: Access resources to guide your molecule from lab to clinic

It’s an exciting time to pioneer what could be a life-changing medicine. Clear the path to the clinic with pro tips and expert insights from industry leaders.

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.

Whitepaper: Success in Rare Diseases: Understanding the Rare Disease Ecosystem

Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.”

Content Hub: Emerging Biotech Resource Center

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

Whitepaper: Accelerate innovation and manufacturing to better serve patients

A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields.

Survey: Cell and Gene Clinical Supply Needs Market Research Survey

Cell and gene therapies hold the promise to offer novel therapeutic avenues for individuals facing serious medical conditions, but bringing them through the clinical trial process introduces a level of supply chain risk and complexity.

Whitepaper: Gene and Cell Therapy: A New Age of Medicine

Gene and cell therapy are shifting paradigms for manufacturers, patients, healthcare providers and pharmacies. We invite you to learn more by reading Gene and Cell Therapy: A New Age of Medicine.

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.

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.

Research: Premier Research Resource Hub

Browse the latest learnings and insights from our clinical development professionals.

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.

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.

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