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Today’s Big News

Aug 21, 2024

FDA rejects Regeneron's blood cancer bispecific, delaying would-be challenger to J&J and Pfizer

BioMarin creates new-look R&D and deal teams with Roche’s Sabry, Amgen’s Friberg

BridgeBio launches another offshoot with $300M and early genetic disease programs

Aadi lays off 80% of R&D workforce as Fyarro heads to phase 2 solid tumor fail

Despite cash infusion, Windtree still faces money running out within a year

Pain medicine biotech Latigo taps CRO founder for CMO role

Featured

FDA rejects Regeneron's blood cancer bispecific, delaying would-be challenger to J&J and Pfizer

By Nick Paul Taylor

The FDA has thrown a wrench in Regeneron’s plans to challenge Johnson & Johnson and Pfizer in a blood cancer market, hitting the Big Biotech with a complete response letter over issues at a third-party manufacturer.

BioMarin creates new-look R&D and deal teams with Roche’s Sabry, Amgen’s Friberg

By Nick Paul Taylor

BioMarin Pharmaceutical is shaking up its leadership team, raiding Amgen for an R&D chief to replace a departing company veteran and pulling off the coup of signing a high-profile former Roche dealmaker.

BridgeBio launches another offshoot with $300M and early genetic disease programs

By Gabrielle Masson

BridgeBio Pharma is once again spinning out a chunk of its pipeline, this time offloading a handful of early-stage genetic disease programs to a new company called GondolaBio.

What’s Next for Biotech? Join Fierce Biotech Editors in Boston at Fierce Biotech Summit

Aadi lays off 80% of R&D workforce as Fyarro heads to phase 2 solid tumor fail

By James Waldron

Aadi Bioscience’s Fyarro is on track to fail a phase 2 solid tumor trial, leading the biotech to halt the study and lay off 80% of its R&D workforce.

Despite cash infusion, Windtree still faces money running out within a year

By James Waldron

Windtree Therapeutics received a financial lifeline last month thanks a private placement of its stock, but the biotech still doesn’t have enough money to keep advancing its pipeline of cardiovascular meds for more than a year.

Pain medicine biotech Latigo taps CRO founder for CMO role

By Gabrielle Masson

Pain-medicine-focused Latigo Biotherapeutics is welcoming CRO founder Neil Singla, M.D., aboard as chief medical officer.

New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

By Zoey Becker

Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

By Fraiser Kansteiner

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem.

Fierce podcasts

Don’t miss an episode

The TROP2 race for supremacy

In this week’s episode of “The Top Line,” Fierce executive editor Eric Sagonowsky chats with Angus Liu about his feature story on the three TROP2 front-runners.

A closer look at Fierce Biotech's Fierce 15

How incentives engage and keep patients healthy

Resources

Whitepaper

Launching a Product in Europe: Understanding Supply Chain Cost Drivers

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Efficient-Pro Medium and Feed 1 enable rapid and seamless upstream process development and scale-up for CHO-K1 cells

Download the white paper to learn how this innovative solution can help optimize your mAb production processes. The findings demonstrate the system's robust capability to sustain strong cell growth and high productivity, facilitating a smooth transition from laboratory to production scale.

2024 Life Sciences Industry Outlook

The definitive report on the state of our industry. Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond.