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Today's Rundown

    

Thank you to Janssen Oncology for sponsoring Fierce Biotech's ASCO coverage.

 

 

Featured Story

Organon launches ready to shop for women's health companies in biotech, medtech and more

Before Organon even launched, the new women’s health company spun out from Merck & Co. announced the acquisition of Alydia Health. On launch day yesterday, company executives put out a call for similarly minded companies to come under their wing.

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Top Stories

Merck-partnered Janux hires CMO as its bispecifics near clinic

Janux Therapeutics has named Wayne Godfrey as its chief medical officer. Godfrey joins the Merck-partnered T-cell engager startup as it gears up to take candidates against PSMA, EGFR and TROP2 into the clinic.

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ASCO: Amgen's stomach cancer drug, nabbed in Five Prime buyout, extends patients' lives in phase 2

Amgen battled other biopharma suitors for Five Prime Therapeutics early this year, emerging victorious in March with a $1.9 billion deal to snap up the cancer-focused biotech. Now, the company is painting a fuller picture for bemarituzumab, the crown jewel of the buyout, showing the treatment helped patients with advanced stomach cancer live longer.

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ASCO: Novartis backs up $2.1B Endocyte buyout with prostate cancer data

Two years after splashing out $2.1 billion on Endocyte, Novartis is unveiling full phase 3 data for the radiopharmaceutical it picked up in that deal. The treatment, given alongside standard of care, added four months to the lives of patients with metastatic castration-resistant prostate cancer, helping them live a median of 15.3 months and reducing the risk of death by 38%.

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Stellanova, a 'new star' in the biotech constellation, hopes for bright future with $15.5M series A

Stellanova Therapeutics now has fuel to get the “new star” on its journey to treating the tumor microenvironment. The Houston-based preclinical biotech has raised a $15.5 million series A led by Sporos Bioventures. The funding will go toward bringing Stellanova's lead antibody into the clinic, building out a discovery platform and growing the team, including leadership hires later this year.

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Sanofi inks partners for phase 3 pivotal trial of add-on breast cancer therapy

The French Big Pharma has landed partnerships with three groups to roll out a pivotal trial of its breast cancer hopeful amcenestrant as an add-on therapy, weeks after previewing promising early data at the American Society of Clinical Oncology meeting.

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China's Stemirna raises $188M to fund mRNA COVID-19 vaccine

China’s Stemirna Therapeutics has raised RMB 1.2 billion ($188 million) to bankroll development of an mRNA vaccine against COVID-19. Sequoia Capital China co-led the financing with backers including WuXi AppTec plus assists from OrbiMed and other investors. 

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Ex-FDA deputy Abernethy lands at Verily, ready to steer clinical research

Amy Abernethy joins Verily shortly after her sudden departure from the FDA, where she had served as principal deputy commissioner of food and drugs for a little over two years—and where she was widely seen as a top contender for the agency’s (still-unfilled) top commissioner post.

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It had to happen: Ex-Celgene shareholders sue Bristol Myers Squibb for $6.4B in lost CVR cash, claiming 'blatant misconduct'

When Bristol Myers Squibb failed to take a former Celgene drug past the FDA finish line, that company's shareholders lost out on a $6.4 billion contingency payment agreed as part of their megamerger. Investors railed—and Thursday, they sued.

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How new insights into skull-based immune cells could inspire treatments for brain disease

Researchers at Washington University discovered that some immune cells originate in the skull and migrate to the tissues that line the brain and spinal cord without passing through the bloodstream. Those immune cells shield the brain from disease and could inspire new treatments, they believe.

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Fierce Pharma Asia—Amgen-Kyowa Kirin eczema deal; J&J, Legend's CAR-T; CStone's PD-L1

Amgen paid $400 million upfront to partner up with Kyowa Kirin on an atopic dermatitis candidate. Johnson & Johnson and Legend Biotech's CAR-T therapy scored a FDA priority review. CStone's PD-L1 inhibitor, with Pfizer and EQRx as partners, hit its phase 3 goal in non-small cell lung cancer. And more.

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Chutes & Ladders—Repertoire Immune Medicines, buzzing from $189M series B, taps Celgene vet as CMO

Repertoire has added a former Celgene executive as its new chief medical officer. Renovacor, on the path to going public, has tapped a MyoKardia vet as its CMO. And Stellanova has taken off with a new founding CEO.

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Resources

Whitepaper: How to Launch a Successful BYOD Strategy in Any Phase

For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink.

Paid Marketplace: Story of Success: Ashfield Healthcare Empowers Field Sales to Grow Market Share based on Data

Discover how Ashfield Healthcare uses the power of data and analytics to enable pre-call planning, inform sales rep actions and drive higher market share for its target pharmaceutical products.

eBook: Improving Diversity and Inclusion in Clinical Trials

Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them.

Whitepaper: Closed Cell Processing System Benefits for Cell & Gene Therapy

Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process.

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.

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

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. 

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.

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