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Today's Rundown

Featured Story

Gilead's Kite makes off-the-shelf play with Shoreline Biosciences CAR-NK deal worth as much as $2.3B

Gilead’s Kite unit made its name developing autologous CAR-T treatments made from a patient’s own cells. Now, the subsidiary is making another big play in off-the-shelf treatments that can be developed more quickly in a deal with Shoreline Biosciences that could exceed $2.3 billion. The partners will initially work on CAR targets for natural killer cell therapies for blood cancers.

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Top Stories

FDA rejects Orphazyme's rare disease drug, continuing wild ride for Danish meme stock

The FDA has rejected Orphazyme’s Niemann-Pick disease type C drug candidate arimoclomol. Orphazyme said the agency wants additional data on the benefits and risks of the heat shock protein amplifier, leading it to cut costs as it figures out its next steps.

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Athira CEO placed on temporary leave following allegations she altered doctoral research images

Athira Pharma's CEO and President Leen Kawas, Ph.D., has been placed on leave amid reports that she altered images in academic research conducted at Washington State University. The news, which dropped after market Thursday, sunk the company's shares 44% to $10.79 apiece as of 10:50 a.m. ET.

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Sponsored: Inside Track: Behind the Scenes of a Major Biotech SPAC

Take a closer look at the SPAC phenomenon with Dr. David Hung, Founder and CEO of Nuvation Bio and Michelle Doig, Omega Funds Partner and President of its Omega Alpha SPAC.

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Bristol Myers pays $650M for rights to Eisai's phase 1 ADC

Bristol Myers Squibb is paying $650 million to secure rights to Eisai’s folate receptor alpha-targeted antibody-drug conjugate MORAb-202. The deal, which is worth up to $2.5 billion in milestones, sets Bristol Myers up to work with Eisai to get the drug into a registrational study next year.

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U.S. injects $3B-plus into COVID-19 research to develop antiviral pill within a year

The U.S. government has given nearly $20 billion to COVID-19 vaccines. Now, the focus shifts to oral antiviral pills to help prevent serious illness and hospitalizations of COVID-19 and other potential pandemic viruses.

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Backed by Boehringer Ingelheim fund, Nuevocor snags $24M to tackle diseased hearts with gene therapy

Nuevocor wants to restore cardiac function to diseased hearts through gene therapy and now has the backing of Boehringer Ingelheim through a $24 million series A. The Singapore-based startup's lead candidate is an adeno-associated virus-based gene therapy for patients with dilated cardiomyopathy caused by mutations that aren't eligible for conventional gene therapies.

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Johnson & Johnson among companies excluding Colorado residents from remote job openings after new state law

A new Colorado law, designed to narrow the gender pay gap, requires companies to list salary range on job postings. But Johnson & Johnson and other large companies have responded by excluding candidates from Colorado.

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Sen. Manchin calls for Woodcock's removal as FDA fallout from Biogen Alzheimer's approval heats up

Sen. Joe Manchin, a moderate Democrat from West Virginia, told President Joe Biden in a letter that interim FDA Commissioner Janet Woodcock is "not the right person to lead the FDA" following the agency's controversial decision to approve Biogen's Alzheimer's drug Aduhelm.

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New COVID-19 approach exploits protein response in human cells to combat virus

The development of COVID-19 drugs has mostly focused on directly targeting the SARS-CoV-2 coronavirus. But scientists at the University of Cambridge are taking a different approach to treating the disease by looking at an infection response pathway in human cells.

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Experts: ACA likely safe from large-scale legal attacks after latest Supreme Court win

The Supreme Court's latest decision to preserve the ACA likely foretells the end of large-scale legal attacks on the healthcare law, but lawsuits challenging other parts will continue.

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Fierce Pharma Asia—Daiichi Sankyo, AZ's Enhertu trial; Celltrion's COVID antibody win; Zai Lab's MacroGenics deal

AstraZeneca and Daiichi Sankyo launched a phase 3 trial for Enhertu in front-line breast cancer. Celltrion's coronavirus antibody helped keep COVID patients outside the hospital. Zai Lab licensed four cancer bispecifics from old partner MacroGenics. And more.

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Chutes & Ladders—Ex-FDA chief Hahn joins Moderna backer

Ex-FDA chief Hahn joins Moderna backer Flagship Pioneering; One Drop poaches Sanofi's head of diabetes innovation; J&J's Burton grabs hold of Moderna rocket ship as chief medical officer.

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Resources

Whitepaper: How the rapid shift to point-of-care is reshaping diagnostics

Learn how the diagnostics industry is being fundamentally transformed with point-of-care molecular testing.

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

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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