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Today’s Big News

May 7, 2024

Lilly gets a date with FDA to discuss Alzheimer's med donanemab

Zenas adds $200M series C to reach a bucket of key readouts for lead monoclonal antibody

Nominations for Fierce Biotech's 2024 Fierce 15 are now open!

FDA advisers to weigh first psychedelic therapy in early June

Vertex files FDA approval ask for next-gen cystic fibrosis candidate, resumes diabetes cell therapy trial

Calliditas' survival data salvage midphase cancer trial after primary endpoint miss

Glioblastoma vaccine turns brain tumors from cold to hot in humans and dogs

Fierce Biotech Fundraising Tracker '24: Flagship’s Prologue raises $50M; Zenas snags $200M

Featured

Lilly gets a date with FDA to discuss Alzheimer's med donanemab

By Annalee Armstrong

Mark your calendars: Eli Lilly will come before the FDA’s advisory committee to discuss Alzheimer’s disease medicine donanemab June 10.

Zenas adds $200M series C to reach a bucket of key readouts for lead monoclonal antibody

By Max Bayer

Zenas BioPharma has raised a $200 million series C to fund further clinical development of its lead autoimmune treatment. The company expects four mid-to-late-stage readouts before 2026.

Nominations for Fierce Biotech's 2024 Fierce 15 are now open!

By Annalee Armstrong

Fierce 15 is here! Nominations are open now in search of the best and brightest in biotech.

Progress Toward a New GAD Treatment Paradigm

FDA advisers to weigh first psychedelic therapy in early June

By Max Bayer

Lykos Therapeutics’ MDMA-assisted therapy is charting yet another first in the psychedelic field: an FDA advisory meeting.

Vertex files FDA approval ask for next-gen cystic fibrosis candidate, resumes diabetes cell therapy trial

By Gabrielle Masson

Vertex Pharmaceuticals is ahead of schedule, filing a new drug application for its next-gen cystic fibrosis (CF) treatment, dubbed vanza triple.

Calliditas' survival data salvage midphase cancer trial after primary endpoint miss

By Nick Paul Taylor

Calliditas Therapeutics had a typical to-do list for its midphase head and neck cancer study. Step one, show the molecule shrinks tumors. Step two, look for early evidence of effect on survival.

Glioblastoma vaccine turns brain tumors from cold to hot in humans and dogs

By Helen Floersh

A personalized mRNA-based cancer vaccine for glioblastoma with an “onion-like” delivery mechanism appears to prolong survival both in dogs and in humans, the results of a small study suggest.

Fierce Biotech Fundraising Tracker '24: Flagship's Prologue raises $50M; Zenas snags $200M

By Gabrielle Masson,Annalee Armstrong,Max Bayer

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

Milken Institute: How employers can change the paradigm for obesity care

By Paige Minemyer

Employers are in a strong position to lead the charge in changing the conversation around obesity care, according to a new report from the Milken Institute.

Outset Medical rebounds on new FDA clearance for dialysis cart

By Conor Hale

Outset Medical has resumed distributing its portable dialysis machine after halting sales last summer, now that it’s obtained a necessary green light from the FDA.

Vertex's Casgevy launch progresses as CF business posts impressive growth

By Fraiser Kansteiner

As of mid-April, Vertex said it had collected 5 patients' cells for eventual treatment with sickle cell disease therapy Casgevy. That puts Vertex ahead of its gene therapy rival bluebird bio, which recently said it had collected just one patient's cells for its own SCD treatment Lyfgenia.

Fierce podcasts

Don’t miss an episode

A closer look at 2023's top biopharma deals and what lies ahead

This week on "The Top Line," we're diving into the details of the spree of big-money biopharma deals in 2023 and examining what that means for this year.

'Podnosis': Inside the plans to build a health innovation hub in New Jersey’s SciTech city

'The Top Line': A look at pharma revenue rankings

Resources

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

Whitepaper

Vaccine Development Challenges in Facing Influenza and COVID-19

Explore the complex considerations of vaccine development for influenza and COVID-19, including the challenges posed by viral evolution and the importance of ongoing research in this paper by vaccine expert, Dr. Lisa Kierstead.

Sponsored by: PPD®️ Laboratory Services

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.

Patient Engagement Series

Discover the secrets behind successful patient engagement

Antibody Profiling: Decoding the Humoral Immune System

Antibody biomarkers are redefining precision medicine, from diagnosing diseases earlier to stratifying patients – download your FREE white paper today!

Straight to Market in an Autoinjector

The use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors.

Presented by Lonza