To view this email as a web page, click here

Today's Rundown

    

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

 

 

Featured Story

Johnson & Johnson culls $1.6B argenx blood cancer drug collab

Johnson & Johnson is walking away from a $1.6 billion biobucks blood cancer med deal with Belgium’s argenx for the CD70-targeting cusatuzumab.

read more

Top Stories

Bluebird bio gets FDA green light to restart sickle cell gene therapy trials after rocky few months

The FDA lifted a clinical hold it placed on bluebird bio’s sickle cell gene therapy in February, making way for the company to get a phase 1/2 trial and phase 3 study of the treatment back on track. Bluebird paused the trials in mid-February after two patients in the phase 1/2 study developed blood cancer after treatment.

read more

ASCO: Amgen deals 'knockdown punch' with Lumakras approval, but decades of work lie ahead

You’d think Amgen would still be celebrating in the halls after scoring an FDA approval for the KRAS inhibitor Lumakras just one week ago, but there’s just too much to do. The company is instead looking to a new cohort from its pivotal trial, which is beginning to reveal the patients most likely to benefit from the drug formerly known as sotorasib.

read more

Sponsored: In a Year of Crisis, Maryland Biotech Responds with Leadership

Prior to the pandemic, nearly a quarter of Maryland’s biopharm and medical tech companies focused on infectious diseases. As COVID-19 spread, dozens of Maryland companies joined the global response.

read more

Novartis rolls out encouraging phase 2 data in rare kidney diseases with little competition in sight

Novartis rolled out results from two phase 2 trials for investigational kidney disease medicine iptacopan that showed stabilization of kidney function in one and the reduction of a key marker for kidney disease progression in the other.

read more

Sponsored: Innovative POC MATLOC Digital Device for CKD

Health Logic Interactive is working on advanced technology called MATLOC that has the potential to revolutionize the Chronic Kidney Disease treatment space from the ground up.

read more

Elevation files for $100M IPO to fund tumor-agnostic candidate

Elevation Oncology has filed to raise $100 million in an IPO. The money will support development of an anti-HER3 antibody that failed multiple trials at Merrimack Pharmaceuticals before being picked up by Elevation and repositioned as a treatment for solid tumors harboring an NRG1 fusion.

read more

Iksuda raises $47M to take CD19 antibody-drug conjugate into clinic

Iksuda Therapeutics has raised $47 million to take a CD19-targeted antibody-drug conjugate (ADC) into the clinic. The British biotech has ceded a big head start to CD19 ADC leader ADC Therapeutics but thinks it can come from behind by delivering a best-in-class product.

read more

Could a breast cancer candidate treat COVID-19? Polyphor's drug shows dual action in early studies

A Swiss biotech suggests that one of its clinical candidates, currently in late-stage development for breast cancer, may also work as a COVID-19 treatment. The drug, called balixafortide, reduced viral load of the coronavirus that causes COVID, as well as COVID-related inflammation markers, in hamsters.

read more

Grail launches its 50-cancer Galleri blood screening test

Currently available in the U.S. with a prescription, the Galleri test is meant to help screen people who may already have an elevated risk for cancer, such as adults over the age of 50.

read more

ASCO: Alpine reports 61% 'clinical benefit' in early trial of CD28-targeted immuno-oncology drug

Alpine Immune Sciences turned heads when AbbVie formed a deal with the company for a lupus drug that inhibits the immune protein CD28. But the company is also pursuing a strategy for stimulating CD28 to improve the immune response to cancer—and it presented evidence at ASCO that its plan may be working.

read more

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.

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.

Events