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Today's Rundown

Featured Story

Merck bags solid tumor CAR-NKs from Artiva to push into cell therapy

Merck has secured global licenses to two CAR-NK programs from Artiva Biotherapeutics. The deal gives Merck control of two off-the-shelf solid tumor cell therapies in return for $30 million upfront and potentially many times that in milestones. 

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

Top Stories

Medigene shares sag as it axes TCR-T blood cancer drug, with COVID-19 partly to blame

German biotech Medigene saw its shares down 7% Thursday after it decided to cull one of its TCR-T cancer assets after delays by COVID-19 restrictions hampered its efforts.

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Lilly lands clinical-phase pain drug via deal with Asahi Kasei

Eli Lilly has struck a deal to buy the near-global rights to a P2X7 receptor antagonist from Asahi Kasei Pharma. The agreement will give Lilly control of a treatment for neuroinflammatory pain conditions that recently completed phase 1 studies. 

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WCLC: Takeda's new kinase inhibitor curbs 78% of lung cancers with rare EGFR mutation

EGFR inhibitors like AstraZeneca’s Tagrisso and Genentech’s Tarceva have been on the market for years to treat patients with lung cancer. But those drugs are designed to treat patients with specific mutations and one patient group with a rare type of EGFR mutation has fallen through the cracks. With promising phase 1/2 data, Takeda is one step closer to providing those patients with a targeted treatment.

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Roche joins Sofinnova, AbbVie in Enthera's €35M venture round

Roche’s venture arm is joining the likes of Sofinnova Partners and AbbVie in backing Italy’s Enthera Pharmaceuticals, bringing the diabetes-focused biotech’s series A round to €35 million ($42 million). The funding will bankroll the company's lead program, Ent001, to clinical proof of concept.

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AstraZeneca, BenevolentAI home in on computer-generated target for chronic kidney disease drugs

After launching a collaboration nearly two years ago to bring artificial intelligence to kidney drug design, AstraZeneca and BenevolentAI believe they’ve discovered a winner.

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Cancer drug derived from sea squirts outperforms remdesivir in COVID-19 preclinical models

The search among existing drugs for potential COVID-19 treatments has pointed to another promising candidate—PharmaMar’s myeloma drug plitidepsin. In preclinical studies, it performed better than Gilead Sciences’ FDA-approved remdesivir against the SARS-CoV-2 virus behind the disease and was even effective against a more contagious variant.

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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