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Today's Rundown

Featured Story

Sanofi starts off 'pipeline-in-a-product' rilzabrutinib in rare skin disease, but eyes bigger prize

Sanofi has big dreams for rilzabrutinib in diseases ranging from atopic dermatitis to asthma, but up first for the potential blockbuster is a phase 2 read out for the rare skin disease pemphigus vulgaris.

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Top Stories

Bristol Myers’ deucravacitinib beats out exiled Otezla, plots 2022 launch

Bristol Myers Squibb’s hand was forced when it had to spin-off its blockbuster immunology med Otezla to Amgen, gained via its Celgene buyout, given that it had a similar oral deucravacitinib in the pipeline.

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Inovio's COVID-19 vaccine funding axed as US says thanks but no thanks

U.S. officials have pulled the plug on funding a phase 3 trial for Inovio’s COVID-19 vaccine, telling the biotech that another vaccine is no longer needed as inoculations pick up around the country.

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Sponsored: Why Integrated Partners are Critical to Cell and Gene Therapy Success

Working with the right integrated partner can help ease increasingly common problems with scale, access to high-demand raw material, viral vector production and quality requirements. 

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Oxford malaria vaccine hits WHO threshold for efficacy, plots larger trials

In the middle of a new pandemic, it’s all too easy to forget older epidemics that have killed and continue to kill millions, with poor drug therapies and a weak vaccine.

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Valneva kickstarts Dynavax-partnered phase 3, pitting its COVID vaccine against AstraZeneca’s

Valneva has started a pivotal phase 3 test for its experimental COVID-19 vaccine in a head-to-head against AstraZeneca's conditionally approved pandemic shot Vaxzevria.

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Fierce Pharma Asia—Pharma reputation in APAC; Bharat Biotech, Serum Institute, Fosun COVID vaccine work

Bristol Myers Squibb and Roche led pharma's reputation score in Asia Pacific in this year's Global RepTrack 100 survey. Bharat Biotech and Serum Institute of India won government funding to boost production of COVID-19 vaccines, as Fosun Pharma preps for the potential China launch of BioNTech's mRNA shot. And more.

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Chutes & Ladders—Replimune, prepping for market, taps Genentech oncology vet as CMO

Replimune has snagged Genentech oncology vet Sushil Patel to fill the CCO seat. Humanigen has opened up a CMO role and picked an AstraZeneca vet to fill it. Gossamer Bio's chief scientist will depart for pastures new.

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Biogen readies Alzheimer’s hopeful aducanumab for U.S. launch as stateside sales plummet

Despite looming uncertainty tied to aducanumab's prospects at the FDA, Biogen says hundreds of clinical sites stand ready to administer its Alzheimer’s drug hopeful. Meanwhile, a look at the company's first-quarter revenues outlines just how critical the drug is for Biogen.

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Resources

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.

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: 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