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Today's Rundown

Featured Story

Novavax handed an extra $147M from legacy Warp Speed program as spotlight shines brighter

A biotech with a long and often troubled past is hoping 2021 will be its year, and it’s just been handed a major tranche of cash to help make that happen.

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Top Stories

AstraZeneca drops BCMA drug after seeing early clinical data

AstraZeneca has stopped development of its anti-BCMA antibody-drug conjugate (ADC) in multiple myeloma. The Anglo-Swedish drugmaker was set to take MEDI2228 into phase 2 this year but has opted against forging ahead in the congested BCMA space. 

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Original Vaccitech investor: Biotech no COVID one hit wonder, as IPO injects $110M for broad pipeline

As Vaccitech prices a $110.5 million IPO, one long-time investor says the company has a pipeline that could address a number of killer diseases long after the headlines over the AstraZeneca vaccine’s blood clot concerns fade.

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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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Werewolf Therapeutics howls onto the Nasdaq with $120M IPO

As it chases its shape-shifting cytokine drugs toward the clinic, Werewolf Therapeutics will collect $120 million in its Wall Street debut. After snaring a $72 million private round in January, it filed to raise up to $100 million in its IPO. The company bumped that up to $120 million by upping the number of shares it would offer.

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Cara's stock tanks as atopic dermatitis phase 2 misses endpoint

A phase 2 trial of Cara Therapeutics’ anti-itch treatment has missed its primary endpoint, sending the biotech’s stock price down 45%. Yet, Cara is forging ahead in atopic dermatitis on the strength of an efficacy signal in patients with mild-moderate disease.

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GlaxoSmithKline backs Amgen in PCKS9 patent fight, arguing court decision could 'devastate' R&D incentives

Amgen and Sanofi aren't the only two drugmakers threatened by their high-stakes PCSK9 patent fight. After Amgen suffered a pair of setbacks in the case, GlaxoSmithKline became the latest Big Pharma to weigh in, this time arguing a recent court decision could "devastate" pharma R&D incentives.

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CRISPR screen points to spinal repair pathway in zebrafish

Zebrafish can recover from spinal cord injuries, thanks to a healing process that’s controlled by immune cells called macrophages. Researchers from the University of Edinburgh the gene editing technology CRISPR-Cas9 to identify four genes that are crucial for repairing severed spinal cords.

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Illumina sues European Commission to stop investigation of $8B Grail acquisition

To avoid fighting a two-front, international legal battle over its pursuit of the cancer tester Grail, Illumina has asked judges to step in and halt the European Commission’s review of the proposed $8 billion deal.

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Chutes & Ladders—Lilly vet Bilenker and Novartis' Engelman unite to forge new cancer biotech

Two big name cancer R&D vets have teamed up to form a new oncology biotech. GV, formerly known as Google Ventures, signed on its first executive venture partner. And MiMedx tapped Dirk Stevens as SVP of quality assurance and regulatory affairs.

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Fierce Pharma Asia—Gilead, Merck help India with COVID; BeiGene's BTK win; Astellas' gene therapy loss

Gilead Sciences and Merck chipped in to help India cope with a surge of COVID-19. BeiGene's Brukinsa reported positive results in a head-to-ahead study against Imbruvica. Astellas took a $540 million impairment related to its Audentes Therapeutics gene therapy buy. And more.

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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.

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