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Today's Rundown

Featured Story

Sanofi drops 'intriguing' data on rival to Bristol Myers' bempeg

Sanofi has posted early-phase data on its recombinant IL-2 molecule in solid tumor patients. Analysts at Jefferies called the data “intriguing” while noting it is currently hard to tell whether the drug improves on the IL-2 pathway agonist Bristol Myers Squibb is developing in partnership with Nektar Therapeutics. 

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Top Stories

Life sciences pumping more cash than ever into R&D, but drug pricing limits could stymie that tide: report

As a Democrat-led U.S. government is looking to once again up the pressure on drug pricing, a new report has shown biopharmas are in fact reinvesting more and more sales revenue into R&D.

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Biotech internships in a pandemic? Diversity-boosting Project Onramp adjusts to COVID-19, moves into Philadelphia, plots further expansion

Project Onramp kicked off in 2019 to connect low-income students across Massachussetts to well-paid summer internships at local biotech companies. Since then, the internship program has weathered the COVID-19 pandemic, connected students and companies outside of Massachusetts through virtual internships and expanded into a new city: Philadelphia.

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Sponsored: NAFLD & NASH: Emerging In Vitro Models Aid Drug Discovery

Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are common pathologies without specialized therapeutics, but new models may provide opportunities for drug discovery.

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Provention warns FDA requests could delay diabetes approval

Provention Bio has warned the approval of teplizumab in Type 1 diabetes is likely to be delayed by a request for more information from the FDA. The advisory committee meeting is still scheduled to go ahead late next month, but the July 2 PDUFA date is now under threat.

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Werewolf Therapeutics looks to make a killing in the public markets with a $100M IPO

After banking $72 million at the start of the year, Werewolf Therapeutics now wants an IPO.

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Donisi scores FDA clearance for contactless AI system that spots changes in heart, breathing patterns

It goes against all medical knowledge and basic common sense to say that vital signs are only skin deep, but that’s exactly the case for a newly FDA-cleared platform from Israel's Donisi Health that can detect shifts in cardiac and pulmonary performance from afar.

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Fierce Pharma Asia—Takeda-CSL COVID fail; Daiichi Sankyo's new 5-year plan; Legend-J&J CAR-T filing

Takeda and CSL's COVID-19 plasma-derived therapy failed a phase 3 trial. Daiichi Sankyo expects nearly $6 billion in cancer sales in fiscal 2025. Legend Biotech and Johnson & Johnson finished a rolling submission of their CAR-T therapy cilta-cel in multiple myeloma. And more.

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Chutes & Ladders—3 weeks after leaving bluebird, CMO Davidson lands at Tessera

Bluebird's former CMO has landed at Tessera three weeks after flying the nest. Thermo Fisher veteran Zhang has landed the CEO spot at genomics up-and-comer Mission Bio. Medable, enjoying a pandemic boost to its decentralized trial services, has tapped Pamela Tenaerts, M.D., as its chief scientific officer.

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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.

Report: State of the Industry Report: Embracing Trial Change and Elevating IRT Systems

This industry report reveals qualitative and quantitative candid insight from clinical development insiders and their views on current clinical trial challenges faced amidst uncertainty.

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