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Stage 1 of the FDA’s LDT phaseout policy is fast approaching and will require strict adherence to the corrections and removals process. Remain compliant and safeguard public health – download our guide for the 7-step overview. 
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Today’s Big NewsDec 13, 2024 |
| By Gabrielle Masson AbbVie is paying $200 million to snap up Nimble Therapeutics, a Roche spinout working to develop oral peptide treatments in the autoimmune space. |
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By Nick Paul Taylor Gilead has raided Sanofi for its next chief medical officer, luring Dietmar Berger, M.D., Ph.D., away from the French drugmaker to replace Merdad Parsey, M.D., Ph.D. The appointment reunites Gilead CEO Daniel O’Day with a key member of the oncology team from his time at Roche. |
By James Waldron Editas Medicine is laying off three-quarters of its workforce, including its chief medical officer, after the gene-editing biotech was unable to find a partner for its sickle cell disease medicine. |
Sponsored by NVIDIA For all the consumer-facing headlines of generative AI’s healthcare failures—some less serious, others more troubling—a contrast is unfolding in the greater pharma and biotech universe. |
By Andrea Park,James Waldron This week on “The Top Line,” we hear from Novo Nordisk CSO Marcus Schindler about his role at the Danish pharma and what’s next for the GLP-1 drug class. |
By James Waldron Boundless Bio’s freshman year on the public markets hasn’t been easy, with “modest” layoffs in the summer followed by news this week that the company is dropping a clinical-stage candidate and shaking up its C-suite. |
By Nick Paul Taylor BeiGene has struck a $150 million deal to license a cancer candidate from CSPC Zhongqi Pharmaceutical Technology, positioning it to explore a drug combination that has attracted the interest of Amgen. |
By Darren Incorvaia,Zoey Becker Billion-dollar biotech startup Xaira is expanding its C-suite with some top pharma talent. After wrapping up a 16-year tenure at Roche in June, Paulo Fontoura, M.D., Ph.D., is set to become Xaira’s chief medical officer in early 2025. |
By James Waldron Newron Pharmaceuticals has secured 44 million euros ($46.1 million) in upfront cash from an Eisai subsidiary for select Asia rights to its add-on schizophrenia treatment. |
By Gabrielle Masson Despite “encouraging” new data, iTeos Therapeutics is dropping a midstage cancer asset to focus on other programs, a move that will bring the biotech's clinical pipeline down to two investigational meds. |
By Gabrielle Masson Eye-focused biotechs Tenpoint Therapeutics and Visus Therapeutics are joining forces, setting their sights on filing a new drug approval application next year for a presbyopia-correcting eye drop. |
By Darren Incorvaia LAB eN2, the drug discovery accelerator launched by Evotec and Novo Nordisk in September 2023, has unveiled its first three projects and launched an expansion featuring five new academic partners. |
By Paige Minemyer Several key Democratic lawmakers sent a letter to President-elect Donald Trump's pick to lead the Centers for Medicare & Medicaid Services this week expressing concern about his ties to the insurance industry. |
By Angus Liu AstraZeneca and Daiichi Sankyo shared the pooled analysis behind the refiling of their TROP2 ADC with the FDA. The BIOSECURE Act missed a key opportunity to become U.S. law. Three top executives at Amgen China reportedly left the company. And more. |
Fierce podcasts Don’t miss an episode |
| This week on “The Top Line,” we hear from Novo Nordisk CSO Marcus Schindler about his role at the Danish pharma and what’s next for the GLP-1 drug class. |
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Whitepaper We interviewed 14 R&D biopharma leaders on the critical success factors for building a Best Practice R&D organization. This report shares what we learned. Presented by Blue Matter, strategic consultants in the life sciences |
Whitepaper Explore the robust cross-platform agreement between scRNA-seq and bulk RNA-seq, ensuring consistent and reproducible data on immune cell presence. Sponsored by: IQVIA Laboratories |
Whitepaper 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 |
Whitepaper Learn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes. Presented by: Thermo Fisher Scientific |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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