| 05.30.24 | The downside of cell therapy's autoimmune pivot; New FDA guidance may ease gene editing applications

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Today’s Big News

May 30, 2024

Cell therapy reckoning: Pivot to autoimmune leaves unmet need in oncology

Cell therapy reckoning: How a 'remarkable resolution of lupus' carried CAR-T from cancer to immunology

FDA rolls out platform technology guidance to smooth future regulatory encounters

J&J’s daily add-on pill improves depression and insomnia symptoms, acing phase 3

Soterios sees phase 2 win for alopecia cream as offering alternative to JAK domination

Immunovant shunts next-gen FcRn drug ahead of batoclimab in race to rival Vyvgart

Public-private collaboration aims to take ALS therapies beyond ‘a shot in the dark’

Fierce Biotech Fundraising Tracker '24: Grey Wolf cashes in ahead of ASCO; CinRx circles up $73M

Rethinking evidence generation strategies to meet legislative changes in the US and Europe

Avalere Health’s experts unpack the impact of the IRA and JCA on product commercialization, including how to iterate evidence-generation planning to engage every stakeholder and emphasize the patient voice. Download the article.

Featured

Cell therapy reckoning: Pivot to autoimmune leaves unmet need in oncology

By Annalee Armstrong

A Special Report from the Fierce Biotech team on the state of cell therapy.

Cell therapy reckoning: How a 'remarkable resolution of lupus' carried CAR-T from cancer to immunology

By Helen Floersh,Annalee Armstrong

Findings from a series of patient studies in Germany have sparked a frenzy of interest in CAR-T therapy for autoimmune disease, with companies like CRISPR Tx, Kyverna, Novartis and others investing in the approach.

FDA rolls out platform technology guidance to smooth future regulatory encounters

By Annalee Armstrong

To speed up drug applications, the FDA has laid out new guidance on how to request a platform designation that can smooth subsequent applications for biotechs working off the same reproducible technology.

J&J’s daily add-on pill improves depression and insomnia symptoms, acing phase 3

By Gabrielle Masson

Johnson & Johnson’s oral add-on drug significantly improved depressive symptoms and sleep outcomes in a phase 3 trial for patients who previously did not benefit from antidepressants alone.


A message from Watson-Marlow Fluid Technology Solutions

Soterios sees phase 2 win for alopecia cream as offering alternative to JAK domination

By James Waldron

Soterios Pharma is eyeing phase 3 after a 1% dose of the company's alopecia areata cream improved severity of the condition, hitting the main goal of a mid-stage trial.

Immunovant shunts next-gen FcRn drug ahead of batoclimab in race to rival Vyvgart

By James Waldron

Immunovant’s decision to prioritize a next-gen FcRn antibody over phase 3 myasthenia gravis prospect batoclimab means Vyvgart’s crown remains secure for the time being, analysts have concluded.

Public-private collaboration aims to take ALS therapies beyond ‘a shot in the dark’

By Helen Floersh

Government agencies, nonprofits and dozens of biotechs have signed on to a $60 million, five-year partnership that will establish a central repository for data on ALS patients.

Fierce Biotech Fundraising Tracker '24: Grey Wolf cashes in ahead of ASCO; CinRx circles up $73M

By Gabrielle Masson,Annalee Armstrong,Max Bayer

Welcome to Fierce Biotech's Fundraising Tracker, 2024's version.

House Republicans' new 340B bill 'a pharmaceutical industry wish list,' hospitals say

By Dave Muoio

Critics of the increasingly scrutinized 340B program applauded a new bill that tightens eligibility and public reporting requirements. Hospitals, who have increasingly leaned on the drug discounts in recent years, say it'll hamper patient access to lower cost treatments.

Novartis brings augmented reality tech to ASCO to simulate leukemia patient experience

By Andrea Park

Living with chronic myeloid leukemia can feel as if you’re lugging around a massive weight everywhere you go—and Novartis is hoping to give doctors a taste of that experience so they can better understand their patients’ burden.

Fierce podcasts

Don’t miss an episode

Automation, decentralization and the future of CAR-Ts: Advancements in cell & gene therapy manufacturing (Part III)

This week’s episode of “The Top Line,” is the final part of a three-part series diving into the latest advancements in cell and gene therapy manufacturing.

A look at telehealth's future and an omnichannel approach to care

From cell collection to commercial contracting: Advancements in cell & gene therapy manufacturing (Part II)

Webinar: Redefining Antibody Specificity Profiling for IND

Thursday, June 6, 2024 |11am ET / 7am PT

Assessment of antibody off-target reactivity is a regulatory requirement for clinical development. However, conventional screening methods are often ineffective in screening newer therapeutic modalities, and their predictive value for in vivo safety and toxicity is poor. Join us for a look at the new alternatives for success. Register now .

Resources

Whitepaper

Fresenius Medical Care gets 25x faster kidney disease insights

This detailed case study shows how Fresenius Medical Care achieved 25 times faster insights to help kidney disease patients, launching the world’s largest global database of dialysis care with fully anonymized patient data.

Sponsored by: Privacy Analytics, an IQVIA company

Whitepaper

Comprehensive Cell Solutions: Focus on Cellular Therapy Collections

Precision collection of cell therapy source material doesn’t happen by chance. Our new whitepaper illuminates the science and strategies for successful apheresis.

Sponsored by: Comprehensive Cell Solutions

Whitepaper

In Vitro Antibodies – Next-Gen Science Delivers Optimized Candidates

Learn how Specifica’s in vitro antibody discovery platform can deliver better antibodies than traditional immunization approaches.

Sponsored by: Specifica, a Q2 Solutions company

Whitepaper

Branded Digital Companions in Biopharma

This paper defines “digital companions” in biopharma, explores their value from the patient & company perspectives, & outlines a process for successfully fielding a new digital companion.

Presented by: Blue Matter, strategic consultants in the life sciences

eBook

Designing Patient-Centered Endpoint in Rare Disease Trials

To make every rare disease trial count, we design patient-centric, relevant strategies for sponsors and caregivers to produce impactful results every time.