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Today's Rundown

Featured Story

ACC 2021: BMS unveils more data for mavacamten, nabbed in $13B MyoKardia buyout

Bristol Myers Squibb ponied up $13 billion for MyoKardia last fall, just months after it showed its targeted drug could prevent thickened heart muscle from blocking blood flow in patients with an inherited heart disorder. Now, the Big Pharma is unveiling more data from that phase 3 study, highlighting the drug’s effect on patients’ symptoms and quality of life.

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Top Stories

2nd time lucky for Sanofi-GSK after passing small midstage COVID shot; eye approval by year-end

After fumbling their first attempt, once rivals but now partners Sanofi and GlaxoSmithKline have passed a small phase 2 COVID-19 vaccine test, plotting a much larger phase 3 in the coming weeks and a 2021 approval.

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ACC 2021: With Amgen out of the picture, Cytokinetics imagines supporting role for omecamtiv in heart failure

A 14-year-long partnership with Amgen is coming to an end this week, but Cytokinetics is pressing on to file the heart drug the two companies collaborated on to the FDA—in more of a supporting role than originally planned.

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Ginkgo tees up its next acquisition just days after inking $2.5B SPAC deal

Barely a week after striking a $2.5 billion SPAC deal to go public, Ginkgo Bioworks is going international. In its first move to extend its operations beyond the U.S., the synthetic biology player is acquiring Dutch DNA Biotech, a contract manufacturing organization that makes enzymes, proteins and organic acids using its fungus-based technology.

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Blueprint adds another BMS vet to its roster with new CSO

Blueprint Medicines rejigged its R&D organization last fall, bringing its research and clinical development teams under one roof and putting Fouad Namouni, M.D., Bristol Myers Squibb’s former oncology head, in charge. Now, the company is adding another BMS veteran to the team: Percy Carter, Ph.D., who will spearhead research and preclinical development as the new chief scientific officer.

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PrecisionLife, Cyclica ally to co-market computational discovery platforms

PrecisionLife and Cyclica have agreed to co-market their computational platforms. The partners aim to collaborate on up to 30 pharma and biotechnology drug discovery programs over the next two years.

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Landos Biopharma teams up with LianBio for $218M-plus collab and sales deal for 2 immunology assets in Asia

Drug licenser LianBio and recently IPO’d autoimmune biotech Landos Biopharma are joining forces to develop and sell two ulcerative colitis and Crohn’s disease assets in China and parts of Asia.

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Incyte's ruxolitinib cream hits goal in vitiligo phase 3 trials, teeing up regulatory submissions

Phase 3 trials of Incyte’s ruxolitinib cream in patients with vitiligo have met their primary endpoints. The success of the topical JAK inhibitor tees Incyte up to seek approval in the U.S. and Europe in the second half of the year.

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The top 10 medtech VC rounds of 2020

In 2020, medtech companies raked in $6.4 billion in venture funding, quite a bit above the $5.7 billion investors poured into the sector in 2019. Here’s how they split the pot—and what each company is doing now to top a record-setting year.

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Prepping the next generation of COVID-19 vaccines and treatments

Many biopharma companies are betting the novel coronavirus is here to stay—and they’re continuing to develop vaccines and drug treatments to keep it under control. They include CureVac, which said the next-gen version of its mRNA COVID vaccine was effective in a rodent study, and Memo Therapeutics, which described the antibody drug candidate it's developing.

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Resources

Guide: Your Guide to Overcome Inconsistent Clinical Data Standards

Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials.

Whitepaper: The Journey to a Global Modular Content Strategy

One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster.

E-Book: 7 Keys to Success in Europe

This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe.

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: 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