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Wednesday, August 7, 2024 | 10am ET / 7am PT Demand for safe, cost-effective RNA manufacturing is increasing. Knowing how to effectively streamline processes and choose the right partners are critical to success. Join us as we explore the latest strategies and solutions to meet today’s increasing demands for safety and cost-effectiveness. Register now. 
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Today’s Big NewsJul 26, 2024 |
| By Nick Paul Taylor Bristol Myers Squibb had had a whiplash change of heart on its BCMA bispecific T-cell engager, halting further development months after filing to run a phase 3 trial. The Big Pharma disclosed the change of plan alongside a phase 3 win for a potential challenger to Regeneron, Sanofi and Takeda. |
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By Kevin Dunleavy Bristol Myers Squibb CEO Chris Boerner said after seeing the final negotiated price for Eliquis that he is "increasingly confident" the company can navigate the impact of the IRA. |
By Conor Hale On a call with investors, President and CEO Kevin Sayer attributed part of the problem to a steep, unanticipated rise in the number of people obtaining rebates for its G7 continuous glucose monitor. |
By Fraiser Kansteiner Despite winning approvals in a range of countries like the U.S., China and Japan, Eisai and Biogen’s anti-amyloid Alzheimer’s disease med Leqembi has come up short in the eyes of European regulators. |
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September 25-27, 2024 | Philadelphia, PA Join the Fierce Clinical Summit, the premier event for clinical research and trial management. Explore topics in Clinical Operations, Quality, and DCT & Technology. Learn, network, and connect with peers to advance industry standards and innovations in clinical trials. Secure your pass today! 
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By Nick Paul Taylor AbbVie could have the hottest cancer drug launch of 2025 on its hands. That is one takeaway from a recent ZoomRx survey, which found oncologists are more aware of and excited about AbbVie’s telisotuzumab-vedotin (Teliso-V) than any other investigational cancer candidate. |
By Gabrielle Masson,Darren Incorvaia Moderna’s board is undergoing major movement, including the departure of co-founder Robert Langer. |
By Kevin Dunleavy In a discussion prompted by AstraZeneca's application for Imfinzi, the FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a revamp of perioperative clinical trial designs in resectable non-small cell lung cancer. |
By Gabrielle Masson,Darren Incorvaia,Max Bayer We really didn't want to have to create another Layoff Tracker this year. But here we are, launching the third annual iteration tracking biopharma layoffs. |
By Fraiser Kansteiner The FDA signed off on Sun’s oral JAK inhibitor deuruxolitinib to treat adults with severe alopecia areata. The drug is now approved in 8 mg tablets under the brand name Leqselvi. |
By Nick Paul Taylor Calliditas Therapeutics’ slimmed-down, truncated and rethought primary biliary cholangitis drug has hit its primary endpoint. But the biotech, which changed the midphase trial to cut costs, only saw a positive trend on liver stiffness and reported a higher rate of treatment-related dropouts on the study drug. |
By Eric Sagonowsky While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions. |
Fierce podcasts Don’t miss an episode |
| In this week’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong highlights some of the most promising companies that made our prestigious Fierce 15 list back in 2014. |
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Wednesday, September 11, 2024 | 2pm ET / 11am PT As the drug development landscape rapidly evolves, artificial intelligence (AI) is emerging as a transformative force, fundamentally reshaping processes and enhancing efficiencies. Join us for a deep dive into AI’s significant impact on streamlining clinical project management, revolutionizing the generation of crucial research outputs and accelerating drug discovery. Register now. 
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Whitepaper 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. Sponsored by: Thermo Fisher Scientific |
Whitepaper In this white paper, Lonza experts delve into the common challenges encountered by ADC developers. They explore new drug product capabilities in relation to cytotoxic drug development and manufacturing, therefore fully completing Lonza’s integrated ADC offering. Further, they discuss how this end-to-end approach can significantly accelerate the timeline to investigational new drug filing and beyond. Read this white paper to learn more. Sponsored by: Lonza |
Whitepaper 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. Sponsored by: AVANT BIO |
Whitepaper In a complex industry like biopharma, being a “Best Practice Organization” (BPO) is essential to success. But what is a BPO & how do you build one? This eBook provides the answers. Sponsored by: Blue Matter, strategic consultants in the life sciences |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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