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Today's Rundown

Featured Story

After setback, Sanofi, GSK take tweaked COVID-19 vaccine into phase 2

Sanofi and GlaxoSmithKline have begun a phase 2 clinical trial of a new version of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. The study start comes around two months after weak clinical data forced the partners to rethink the antigen formulation.

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Top Stories

Daiichi Sankyo poaches Kite's research lead Takeshita from parent Gilead

As Daiichi Sankyo looks to cement its place as a major cancer R&D player, the Japanese Big Pharma is boosting its C-suite by nabbing a cell therapy veteran as its new global head of research and development.

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Otonomy fails phase 3, adding another twist to ear disease saga

A phase 3 clinical trial of Otonomy’s Otividex in inner ear condition Ménière's disease has missed its primary endpoint. The setback comes almost four years after the generation of mixed data from two earlier phase 3 studies persuaded Otonomy to roll the dice on another pivotal clinical trial.

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In Partnership: Commercialization in Canada: Navigating Complex Requirements to Drive Product Success

The Canadian pharmaceutical market, which is among the 10 largest worldwide, has long been viewed as a top-tier launch destination.

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Novellus becomes Fore Biotherapeutics as it completes pivot from diagnostics to precision oncology

NovellusDx started out as a diagnostics company but has been making moves toward becoming a cancer therapeutics biotech in recent months. Now, it’s wrapping its transformation up with a new name and a new CEO: Fore Biotherapeutics and Usama Malik, a former Immunomedics executive who orchestrated the company’s $21 billion buyout by Gilead.

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Genmab creates new CMO, head of experimental medicines role for Ahmadi

Hoping to boost indications for its blockbuster cancer med Darzalex and create a new line of pipeline meds, Genmab has promoted its head of oncology Tahamtan Ahmadi, M.D., Ph.D., to run its research.

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Amping up the immune system's T cells to improve their cancer-killing prowess

A team led by the Princess Margaret Cancer Centre in Toronto discovered that chemotherapy drugs known as DNA hypomethylating agents directly affected the anti-tumor response of a specific type of T cell in several tumor types, including melanoma and breast cancer. They believe their findings could inspire new immuno-oncology combination treatments.

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The 10 most-anticipated drug launches of 2021

Fierce Pharma rounds up the top 10 of who’s who in anticipated drug launches for 2021, ranked by Evaluate consensus sales estimates for global sales in 2026.

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Enrollment Showcase

Specialize Your Career in Pharmaceutical Outcomes

Learn about the Top 5-Ranked UF College of Pharmacy’s online graduate programs in pharmaceutical outcomes & policy. Select from five specializations, including the new pharmaceutical value assessment & communication option. Over half of graduates progress to a new role within one year. Register now.

Resources

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: How to improve the virtual work you do every day

We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met.

eBook: Your Path to Virtualization: Eight parameters to accelerate and optimize your technology strategy

8 parameters to optimize your “Path to Virtualization” across site- and patient-centric capabilities in this Sponsor Edition eBook.

Whitepaper: Navigating the Digital Transformation Journey

Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem.

Whitepaper: A Single Source of Truth: Acorn AI's Commercial Data Model

Acorn AI has developed a flexible and scalable Commercial Data Model that provides pharmaceutical companies with the data-driven insights required to respond to the industry’s ever-changing landscape. Download the whitepaper to learn how Acorn AI’s intuitive data model enables launch success and more. 

Sponsored: Lessons Learned: Best IT Practices to Secure Your Remote Workforce Now

Criminals Are Actively Exploiting The CV-19 Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become A Cybercrime Statistic -- Make These Cost-Effective IT Changes Now!

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.

Content Hub: Emerging Biotech Resource Center

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

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.

Research: Premier Research Resource Hub

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

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