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Today’s Big News

Jun 17, 2024

FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'

New EHA data reveal how badly Gilead's $4.9B bet on CD47 imploded

Takeda flunks pivotal epilepsy tests but mulls path to market for Ovid-partnered prospect

Kyverna's CAR-T relapse in lupus dents autoimmune hopes amid biotech gold rush

Syncona merges Freeline and SwanBio to spur new gene therapy-focused biotech

J&J's phase 2 Sjögren's data support FcRn strategy in the autoimmune disorder

Fierce Biotech Fundraising Tracker '24: Elion raises $81M for antifungal assets; InduPro adds $85M

Featured

FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'

By James Waldron

The FDA has slammed the brakes on MediLink Therapeutics’ trial of a BioNTech-partnered antibody-drug conjugate over the risk of “unreasonable and significant risk of illness or injuries.”

New EHA data reveal how badly Gilead's $4.9B bet on CD47 imploded

By Gabrielle Masson

New data presented at 2024’s European Hematology Association meeting show how Gilead's bet on its now-abandoned CD47 drug magrolimab failed to deliver left and right.

Takeda flunks pivotal epilepsy tests but mulls path to market for Ovid-partnered prospect

By Nick Paul Taylor

Takeda’s late-phase epilepsy program has failed a key test, chalking up misses on the primary endpoints in pivotal trials in two indications. But the Japanese drugmaker still plans to talk to regulators about the next steps for the Ovid Therapeutics-partnered prospect based on the “totality of the data.”

Revolutionizing cancer treatment: the potential of immune-modulating cancer vaccines

Kyverna's CAR-T relapse in lupus dents autoimmune hopes amid biotech gold rush

By Helen Floersh

The “remarkable” success of chimeric antigen receptor T-cell therapy in lupus has led to a gold rush as cell therapy companies shift their focus from oncology to immunology. But a new relapse in a clinical trial may dim the strategy’s glow, at least in the eyes of investors.

Syncona merges Freeline and SwanBio to spur new gene therapy-focused biotech

By James Waldron

Seven months after Syncona threw a financial lifeline to struggling Freeline Therapeutics, the London-based investment firm is giving the biotech another present in the form of fellow gene therapy company SwanBio.

J&J's phase 2 Sjögren's data support FcRn strategy in the autoimmune disorder

By James Waldron

The unveiling of Johnson & Johnson’s full data from the phase 2 trial of nipocalimab in Sjögren's disease suggest that both the Big Pharma and its competitor argenx are on the right track by targeting FcRn antagonism at the automimmune disorder, according to analysts.

Fierce Biotech Fundraising Tracker '24: Elion raises $81M for antifungal assets; InduPro adds $85M

By Gabrielle Masson,Annalee Armstrong,Max Bayer

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

UPDATED: Industry hails Supreme Court's decision to maintain mifepristone abortion pill's access

By Fraiser Kansteiner

In the wake of the Supreme Court’s decision to preserve mail-order access to the abortion pill mifepristone, leaders from across the industry are weighing in with their support.

Tempus AI shares jump 15% in stock market debut as IPO priced at over $6B valuation

By Heather Landi

Tempus AI, a precision medicine company that, as its name implies, uses artificial intelligence to process medical data, popped in its stock market debut Friday, with shares jumping 15%.

Big Pharma's 10 highest-paid CEOs of 2023

By Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Kevin Dunleavy,Zoey Becker

After a period of leadership transition for many of the world's top drugmakers in recent years, the industry's CEO pay rankings appear to be returning to a state of equilibrium.

Fierce podcasts

Don’t miss an episode

Inside this year’s ASCO: Biggest data drops, trends and the best exhibit booth

In this week's episode of "The Top Line," journalists from Fierce Biotech and Fierce Pharma discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead’s virtual reality Trodelvy ride.

Cybersecurity lessons from the Change Healthcare hack

A look at the top 10 pharma drug ad spenders

Resources

Webinar

Enhance your long-term cell & gene therapy success with pDNA manufacturing solutions

Watch our on-demand webinar video to learn more about the challenges in pDNA manufacturing for gene and cell therapy and how to resolve many of these barriers by partnering with our experts through the adoption of vital manufacturing technologies and strategies.

A Comprehensive and Flexible Approach to CMC for Fab and Fc-Fusion Development Programs

New molecular formats are gaining momentum in today’s market. Characterizing these products and developing robust manufacturing processes can help to usher them to market and provide new treatment options for diseases which are currently challenging to treat. Read this white paper to learn more.

Presented by: Lonza

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