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Today's Rundown

Featured Story

AACR: Sanofi's engineered IL-2 clears safety hurdles in early phase 1 data

Sanofi bet big on engineered IL-2 in 2019, dropping $2.5 billion to acquire Synthorx and its lead program, THOR-707. Now, the French pharma is reporting early phase 1 data showing the treatment could deliver the promise of cytokines for cancer treatment without their nasty side effects.

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Top Stories

Sanofi pays $160M for mRNA tech to reprogram T cells in vivo

Sanofi has paid $160 million upfront to buy a preclinical biotech that is using mRNA to reprogram immune cells inside the human body. The technology could enable patients to make their own CAR-T cells, eliminating the complex cell therapy supply chain while improving safety and dosing.

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Vaccitech, the company that developed the AstraZeneca COVID-19 shot, files for a Nasdaq IPO

U.K. vaccine and cancer biotech Vaccitech, now famous (and perhaps in some quarters, infamous) for its tech that delivered the AstraZeneca-University of Oxford vaccine, is gunning for an IPO.

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Sponsored: MyData-TRUST is becoming the undisputed world leader in Data Protection for Health Research

34.4% of worldwide data breaches come from the healthcare sector. Data Protection is no longer just a compliance issue, but a strategic topic. MyData-TRUST was created to support the sector.

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COVID player and Pfizer-partnered Valneva eyes $100M Nasdaq IPO

French biotech Valneva, which has developed a lineup of traveler vaccines and is starting a late-stage COVID vax effort, is seeking to level up to the Nasdaq with a $100 million IPO.

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Sage, Biogen's tremor drug hits goal, but 38% of people drop out 

A phase 2 clinical trial of an essential tremor drug candidate in development at Biogen and Sage Therapeutics has met its primary endpoint. The trial linked SAGE-324 to the hoped-for improvement on an upper limb tremor score, but the side effects proved to be intolerable to some patients.

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AACR: Zentalis' WEE1 inhibitor shows promise in phase 1, with potential for combos down the line

PARP inhibitors such as Merck and AstraZeneca’s Lynparza have changed the game for patients with ovarian cancer, but they’re still not a cure, as cancers can outsmart these drugs and develop resistance. Zentalis Pharmaceuticals is developing a WEE1 inhibitor that it hopes to combine with PARP inhibitors and other cancer medicines to boost their efficacy—and its early phase 1 data are promising.

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AACR: OncoMyx's engineered rabbit pox virus shows promise in lung cancer model

OncoMyx Therapeutics showed its armed rabbit pox virus could stimulate several inflammatory pathways relevant to an anti-tumor immune response. The therapy slowed tumor growth in a mouse model of non-small cell lung cancer.

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FDA joins Europe in probing rare blood clots after Johnson & Johnson's COVID-19 vaccine

Drug regulators in Europe last week flagged rare but “serious” cases of blood clots in people who had received Johnson & Johnson’s COVID-19 vaccine. But it’s not just European regulators taking a close look at the shot’s safety profile—the FDA is, too. 

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The top 10 medtech M&A deals of 2020

Outside of unceasing demand for protective equipment, ventilator hardware and diagnostic tests, the COVID-19 pandemic brought many medical procedures to a standstill and slowed the rate of medtech mergers and acquisitions to a crawl. But last summer the dam burst, and money flowed like it could make up for lost time.

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Resources

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.

Annual Report: Why do US pharma come to Russia for clinical trials.

Find out why more than 400 clinical trials annually are initiated in Russia by US and EU pharma in the free annual report by OCT Clinical.

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.

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.

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: 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