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Today's Rundown

 

    

Thank you to Catalent for sponsoring Fierce Biotech's ESMO 2021 news coverage.

 

Featured Story

FDA hits pause on Protagonist's blood cancer med after mouse study turns up skin tumors

Protagonist Therapeutics’ treatment for a rare, slow-growing blood cancer is under an FDA clinical hold after the company reported safety concerns in a nonclinical mouse study. The mice in the study developed benign and malignant skin tumors, the company announced in a statement on Friday.

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Top Stories

AstraZeneca taps Dana-Farber's Rahma to lead its GI oncology work

AstraZeneca is following suit of many other pharmas and tapping academic and cancer organizations to fill out its oncology research team.

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ESMO: Novartis links prostate cancer drug to improved pain, quality of life as regulatory filings near

Novartis is building the case for its radioligand therapy. With positive phase 3 primary endpoint data in the bag, Novartis arrived at the European Society of Medical Oncology Congress 2021 armed with evidence of the therapy’s effect on quality of life and pain.

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Sponsored: Four Steps to Smarter, More Dynamic Deployment

Are you using data and analytics to design smarter campaigns and more effective sales rep deployment?

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Elevian snags $40M for stroke recovery and age-related diseases

Elevian has picked up another $40 million to bankroll its work in age-related diseases. The funding will bankroll phase 1 trials, slated for 2023, testing its lead program for stroke recovery.

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ESMO: Daiichi unveils first early peek at next-gen ADC as analysts see strong data against rivals

Daiichi Sankyo has seen some great successes in the clinic, the deal room and commercially when it comes to antibody-drug conjugates, but it’s not resting on its laurels.

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Everest adds to base camp with $561M biobucks deal for Sinovent-SinoMab's renal disease treatment

Everest Medicines bought into the COVID-19 vaccine and mRNA space earlier this week, and, now, the biopharma is paying up to $561 million to reach the summit in renal disease treatments. 

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Vifor doles out $55M upfront to license Travere's late-stage kidney asset slated for US filing next year

Sparsentan has gone through the wringer in recent months after the FDA denied an accelerated approval in May. Now, just one week after a successful meeting with the regulatory agency, Travere has a licensing agreement with Vifor Pharma that includes $55 million upfront and up to $135 million in biobucks. 

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Pyxis Oncology names new CMO to lead development of next-gen antibody-drug conjugates

Pfizer darling Pyxis Oncology will advance its lineup of oncology antibody-drug conjugates with the help of a newly-appointed chief medical officer.

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Excision's CRISPR gene editing therapy for HIV is heading into human testing after FDA clearance

A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing. Excision BioTherapeutics will usher the CRISPR-based therapy EBT-101 into clinical trials after the FDA cleared an investigational new drug application.

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First witnesses in Elizabeth Holmes' fraud trial say Theranos manipulated lab data, inflated revenue projections

The first two witnesses took the stand this week in former Theranos CEO Elizabeth Holmes’ federal fraud trial, both former employees of the disgraced blood-testing startup who mapped out the corners they say were regularly cut in the lab, the boardroom and beyond.

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How do faulty genes drive cancer? There's a surprising immune connection, study finds

A study out of Howard Hughes Medical Institute found that more than 100 mutated cancer-suppressor genes don’t act directly on cancer cells to cause them to grow, but rather block the immune system from recognizing and destroying tumors. They believe further research into those immune pathways could inspire new treatments.

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Fierce Pharma Asia—Takeda's lung cancer nod; 4th death in Astellas' gene therapy trial; Everest's mRNA play

Takeda snagged an FDA nod for a niche lung cancer med to challenge Johnson & Johnson's bispecific antibody. The FDA slapped another clinical hold on Astellas' gene therapy trial after a patient death. China's Everest Medicines bought its way into the mRNA sector. And more.

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Chutes & Ladders—AltruBio snags new CMO with resume at Sublimity, Ardea, Amgen and Abbott

After pivoting to immunology, AltruBio picked up a new chief medical officer from Sublimity Therapeutics who also held director-level roles at Ardea and Amgen. Rusty Williams is back from Prime time, this time leading Walking Fish Therapeutics as CEO. And ViaCyte filled its vacant chief scientific officer role with an academic.

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Resources

Whitepaper: Applications of Digital Twins in Clinical Trials for Alzheimer’s Disease

Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes.

Whitepaper: Evaluating current manufacturing platforms for recombinant AAV production

Choose the right AAV platform for your viral vector-based therapy

Whitepaper: The Value of Precision Medicine Informatics Initiatives Research Findings

Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives.

Whitepaper: Challenging Tradition: The Argument for Integrated Commercialization to Improve Operational Agility

Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how.

Whitepaper: High-yield NK cell culture for allogeneic cell therapy applications

Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications.

Whitepaper: Going from Process R&D to Clinical APIs Quickly and Effectively

Read four customer success stories and four success factors that helped move pharmaceutical customers of Cascade Chemistry by Aceto quickly and effectively to clinic with trial-ready APIs.

Webinar: Let A Digital Sherpa Uncomplicate The Path for Patients

Topple barriers to getting patients started on therapy. Guide them with mobile.

eBook: Get solutions to market faster

Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization.

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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