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Today's Rundown

Featured Story

The top 15 biopharma licensing deals of 2020

Oncology, specifically immuno-oncology, was the dominant theme in biopharma licensing last year, as cancer drugs accounted for half of the top deals.

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Top Stories

Biogen, under increasing public pressure, to offer early access to experimental ALS med

After months of holding its ground on not offering an experimental ALS drug to patients outside of clinical trials, Biogen is laying out a plan to do just that. In the two-part program, Biogen will begin with patients with a genetic form of ALS whose diseases is worsening the fastest in mid-July, before expanding into the broader population of patients with this type of ALS.

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Lilly scraps IL-23 psoriasis program despite phase 3 success, focuses on IBD race against AbbVie, J&J

Eli Lilly has scrapped plans to seek approval for mirikizumab in psoriasis. Lilly chose not to enter the crowded market despite the anti-IL-23p19 antibody outperforming Novartis' Cosentyx in a phase 3 trial last year.

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Sponsored: Look before you leap: How a joined-up development strategy pays off for early-stage biotechs

A well-thought-out strategic development plan that brings together nonclinical, clinical, regulatory and commercial experts can improve efficiencies, cut costs, shorten timelines, and increase the chances of success for a new drug program.

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Pyxis debuts next-gen cancer ADCs from under Pfizer's wing

Cambridge, Massachusetts-based Pyxis is developing three antibody-drug conjugates called PYX-201, PYX-202 and PYX-203 for difficult-to-treat cancers. Each therapy could be effective against a number of malignancies with similar traits.

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Ex-Lilly R&D lead Bilenker launches new cancer biotech with Novartis' oncology R&D head Engelman

Josh Bilenker, M.D., and Jeff Engelman M.D., Ph.D., have joined forces to create a new cancer biotech, tapping their combined considerable experience to find new solutions to old oncology research problems.

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Sanofi to divest Pennsylvania R&D site, cut 75 employees

Sanofi will divest an R&D facility in Malvern, Pennsylvania, where investigational medical products are packaged and distributed as the French pharmaceutical giant undergoes a strategic transformation.

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Astellas takes $540M impairment charge over Audentes' gene therapy trial hold

Astellas paid $3 billion to snap up biotech Audentes in 2019 but is still paying for the biotech more than a year down the line.

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GV hires industry veteran Lynch to coach biotech CEOs, identify new investments

GV has hired serial biotech chairman Dan Lynch as its first executive venture partner. The appointment positions Lynch to serve as a coach and adviser to executives at GV’s portfolio companies.

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Verily, LivaNova kick off study of nerve stimulation for treatment-resistant depression

The Uncover study will collect a range of daily mental and physical health data from patients who are using vagus nerve stimulation therapy to relieve the symptoms of major depressive disorder.

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Insights into how COVID outsmarts the gut's immune response could point to new treatments

European researchers used 3D tissue models, or organoids, of the human gut to determine that a particular subpopulation of cells is most affected by SARS-CoV-2. The enhanced understanding of those cells mount an immune response to the virus could enhance the search for new COVID-19 therapies, they said.

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Resources

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: Top 5 Benefits of a Cloud ELN

Discover the benefits of a cloud-native ELN that delivers better performance, security, connectivity, total cost of ownership PLUS sub-second search results through even the largest data volumes.

Special Report: The Marketer’s Guide to Taking the Vaccine Viral

Access this guide for the latest insights into how marketers can use data, technology, and personalized messaging to build vaccine confidence and drive successful immunization efforts.

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.

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