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Today's Rundown

Featured Story

Alnylam's next-gen ATTR amyloidosis drug hits goals in phase 3, teeing up approval filing

A phase 3 clinical trial of Alnylam’s subcutaneous, long-acting treatment for transthyretin-mediated (ATTR) amyloidosis has met its primary endpoint. The success sets the RNAi specialist up to file for FDA approval early this year, although a lack of data comparing the experimental vutrisiran to Alnylam’s own ATTR incumbent Onpattro make it impossible to tell just how good the results are.

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

Top Stories

Scorpion Therapeutics strikes major $162M funding round for 'precision oncology 2.0'

Less than three months after breaking cover with an impressive $102 million series A, Scorpion has whipped up another major funding round, nabbing $162 million for its next-gen cancer drugs.

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Werewolf banks $72M to shepherd shape-shifting cancer meds into phase 1

A year after coming out of the shadows, Werewolf Therapeutics is kicking it up a notch. With $72 million in new financing, the company will push two shape-shifting cytokine drugs into the clinic and ramp up its discovery and preclinical work.

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Sanofi-backed Abcuro bags $42M to trial KLRG1 immunotherapy

Abcuro has raised $42 million in a Sanofi Ventures co-led series A to advance anti-KLRG1 treatments for autoimmune diseases and cancers. The financing positions a leadership team featuring David de Graaf and John Edwards to run a proof-of-mechanism clinical trial in sporadic inclusion body myositis patients. 

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BioGeneration Ventures closes 4th fund, with $170M in tow for early European biotechs

BioGeneration Ventures has closed its BGV IV fund with help from some major pharma VC players as it becomes one of the largest biotech investors in early-stage ventures and company creation in Europe.

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Lexeo Therapeutics emerges with $85M, 18 gene therapy programs and a star-studded team

Founded with NIH small business grants in early 2018, Lexeo is coming out of stealth with $85 million in series A cash, 18 preclinical and clinical programs primarily developed at Weill Cornell Medicine and a star-studded team to move it all forward.

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UC San Diego deploys COVID-19 test vending machines for returning students

As universities nationwide begin a new semester under the COVID-19 pandemic, the University of California, San Diego is making diagnostic screening a more ubiquitous fixture of day-to-day life by offering tests in sidewalk vending machines.

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Pharma condemns pro-Trump 'thugs' and riots—and backs manufacturing group's call for consequences

Pharma executives and trade groups joined the chorus of voices condemning the pro-Trump insurrection on Capitol Hill yesterday. Speaking up on social media and issuing statements against the mob chaos—as Congress worked to certify President-elect Joseph Biden's election—industry reps went so far as to support a call to consider removing President Donald Trump from office.

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Resources

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.

Infographic: 6 Ways Phenotypic Data Improves Decision-Making in Your Drug Development Program

Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline.

Article: Process development and scale-up of pluripotent stem cell manufacturing

Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand.

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.

Whitepaper: Survey Reveals Demand for Clinical Trial Innovation in the Wake of COVID-19

The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement.

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.

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: 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.

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: 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