| Publisher’s Note: Join Fierce Biotech Editors and industry leaders at the Fierce Biotech Summit to network and gain exclusive insights. Don’t miss out — register now! |
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Drug development requires a delicate balance between innovation, speed, and regulatory compliance. The 505(b)(2) pathway offers a strategic avenue for developers to bring qualifying drugs to market more efficiently.
Learn how in our latest guide. 
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Today’s Big NewsSep 27, 2024 |
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Tuesday, October 1, 2024 | 11am ET / 8am PT The clinical trial landscape continues to evolve at a rapid pace. In this webinar, learn how new biomarker detection technologies drive key breakthroughs. With early detection, biomarker testing research can advance disease understanding and management in many care areas. Register now to join us. 
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| By Nick Paul Taylor Cassava Sciences has agreed to pay $40 million to resolve an investigation into claims it made misleading statements about phase 2b data on its Alzheimer’s disease drug candidate. |
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By Nick Paul Taylor Biomea Fusion has escaped from the full clinical hold imposed by the FDA. After reviewing the data, the regulator has cleared Biomea to study its diabetes drug candidate under a revised protocol intended to mitigate liver toxicity concerns. |
By Fraiser Kansteiner Travere is pausing enrollment in its Harmony study evaluating pegtibatinase in classic homocystinuria to make improvements on manufacturing scale-up for commercial production and to fully enroll the phase 3 trial. |
Sponsored by MMC + RXMOSAIC Courtney Walker of MMC and RxMosaic discusses the future of communication roles, emphasizing AI's impact and the growing importance of human connection. She also highlights strategies for rebuilding pharma's reputation, effective leadership communication, and engaging diverse audiences. |
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Developing immunotherapeutic antibodies can be challenging, but potency shouldn’t stand in your way of clinical success. Learn more. 
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By Darren Incorvaia Two biotechs are teaming up to deliver cholesterol-busting mRNA to clogged arteries. Syracuse, New York-based Repair Biotechnologies will use Swiss company Genevant’s lipid nanoparticles to get its cholesterol-degrading tech to atherosclerosis plaques, the companies announced Sept. 26. |
By Darren Incorvaia,Zoey Becker As the biotech approaches $1 billion in sales, Acadia CEO Steve Davis is stepping down and being succeeded by Catherine Owen Adams. Adams most recently led a $20 billion business as senior vice president and general manager, U.S., at Bristol Myers Squibb. |
By Fraiser Kansteiner Bristol Myers Squibb’s $14 billion deal for Karuna Therapeutics has borne fruit with the approval of a promising new schizophrenia drug. |
By Kevin Dunleavy Regeneron and Sanofi have announced that the FDA has expanded the label of megablockbuster Dupixent to treat COPD. With the nod, Dupixent becomes the first biologic treatment for COPD patients in the U.S. |
By Ayla Ellison,Angus Liu,Gabrielle Masson In this week's "The Top Line," Fierce journalists discuss key issues from promising but debated lung cancer data at recent conferences. |
By Angus Liu AstraZeneca and Daiichi Sankyo's Dato-DXd failed to improve survival in a breast cancer study. Gilead's Kite will bow out of its China joint venture with Fosun Pharma. Korea's Yuhan ended an EGFR inhibitor partnership with Johnson & Johnson but signed an HIV drug supply deal with Gilead. And more. |
Fierce podcasts Don’t miss an episode |
| In this week's "The Top Line," Fierce journalists discuss key issues from promising but debated lung cancer data at recent conferences. |
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Whitepaper Unlock the Future of Biotherapeutics with Catalent Biologics! Sponsored by: Catalent Biologics |
Whitepaper Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner. Sponsored by: IQVIA |
Whitepaper Unique Solutions for Drug Discovery and Development Sponsored by: Cell Signaling Technology |
Whitepaper When the fate of your company hangs in the balance, you need expert guidance to navigate the complexities of biotechnology development and to make informed decisions. Sponsored by: WCG |
Whitepaper Power non-invasive, self-sampling solutions using the Colli-Pee™️ first-void urine collection device. Learn more. Sponsored by: DNA Genotek |
Whitepaper Facing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market. Sponsored by: Veranova |
Whitepaper We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned. Sponsored by: Blue Matter Consulting |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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