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Today's Rundown

Featured Story

How Five Prime suitor Amgen battled multiple companies for the biotech—and won

It’s that time when the company bought out by a parent files the saga with the SEC, and, with Amgen and Five Prime Therapeutics, we found out Amgen was not the only interested party.

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Top Stories

Idera's TLR9 drug flunks melanoma phase 3, tanking stock

Idera Pharmaceuticals’ TLR9 agonist has failed to improve on Yervoy in a phase 3 melanoma trial. The miss on the objective response rate endpoint sent shares in Idera down 55%, but the biotech is yet to give up on the drug.

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Medigene loses CMO after slashing staff, blood cancer program

Medigene's chief medical officer and chief development officer, Kai Pinkernell, is bidding the immuno-oncology biotech adieu. His departure comes two months after the company culled a blood cancer program and six months after it revealed it would cut its staff by about 25%.

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In Partnership: Meeting the challenge to deliver COVID-19 relief around the world

Each challenge COVID-19 has presented in the past year has seemed insurmountable yet at every step those obstacles have been overcome, particularly in the pharmaceutical industry tasked with developing vaccines and therapies to combat this crisis.

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Pfizer ships out two cancer ADCs alongside its tech platform to Pyxis Oncology, and its familiar CEO

The hype around antibody-drug conjugates (ADCs) has been growing in recent years after big bucks deals and approvals from the likes of AstraZeneca/Daiichi and Immunomedics putting a spotlight on the approach.

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Sponsored: Avoiding Gene Therapy CMC and Clinical Supply Issues

Gene therapy manufacturing and clinical supply strategies should be in place early to avoid potential late-stage development delays.

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Takeda bags mRNA translation modulators in $120M Anima deal

Takeda has teamed up with Anima Biotech to discover mRNA translation modulators. The Japanese drugmaker is set to pay up to $120 million in upfront fees and preclinical research milestones to work with Anima on the treatments for genetically defined neurological diseases.

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UBiome co-founders charged with fraud by SEC

The founders of microbiome-testing startup uBiome have been charged with defrauding investors out of $60 million by convincing them it was a successful business before being forced to shutter operations, declare bankruptcy and flush all its assets in late 2019, according to the Securities and Exchange Commission.

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How a map of cell signaling networks could identify new targets for pain drugs

Scientists at the University of Texas at Dallas created maps of the pain “interactome” that display likely signaling networks between tissues and neurons that send pain signals to the brain. They used the maps to show that inhibiting the ErbB family of proteins with Novartis' Tykerb could block pain signals in mice.

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Fierce Pharma Asia—Pfizer's China biosim retreat; WuXi Bio's buying spree; Fujifilm's $2B plant

Pfizer pulled the plug on three biosimilar programs in China amid crowded market and sold a plant to WuXi Biologics. The Chinese CDMO also bought a near-100% stake in a local rival. Fujifilm picked Holly Springs, North Carolina to build its $2 billion cell culture facility. And more.

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Chutes & Ladders—Cloonan quits Sage to pursue CEO post as bluebird CMO heads for exit

Delix has tapped a Shire neuro veteran as its new CEO. Sage's chief operating officer is stepping down to pursue a CEO post. And bluebird's CMO is hitting the exit amid the company's gene therapy problems.

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Resources

Content Hub: Emerging Biotech Resource Center

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

Annual Report: Clinical Trial Landscape In Russia and Eastern Europe, 2020.

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.

Guide: Labs of the Future: How to choose a Lab Information Management System in 2021

Interested in moving from hand-written lab notebooks or spreadsheets to a modern research platform? Read this guide on Lab Information Management Systems (LIMS) to learn how modern companies are using software to innovate faster.

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. 

Guide: How to maximize your drug commercialization investments

Unlock product potential by making the most of your commercialization investments. 

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.

eBook: Optimize Trial Performance with AI-enabled Technology & Advanced Analytics

Unlock competitive advantage with AI and advanced analytics.

Whitepaper: The Crush: How COVID-19 Is Impacting Mature Brand Revenue & Long-Term Value

Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How.

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.

Free Infographic: The Future of Vaccine Development

Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain.

Whitepaper: 2021 Outlook for Cell-Based Therapies in Oncology: CAR-T Expansion & Beyond

A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones.

Whitepaper: Seasonal Vaccine Manufacturing

While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery.

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.

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