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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 9, 2024 |
| By Nick Paul Taylor AbbVie has completed a hat trick of phase 3 wins for its Parkinson’s disease prospect tavapadon, teeing the drugmaker up to file for FDA approval of drug candidate in 2025. |
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By Gabrielle Masson For the second time this year, Carisma is laying off staff. The newly announced restructure includes several company leaders hitting the exit and the discontinuation of the biotech’s sole clinical candidate. |
By James Waldron It didn’t take long for the shine to come off one of biotech’s recent IPO success stories, with BioAge Labs scrapping its phase 2-stage obesity prospect barely two months after going public. |
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 James Waldron Enanta Pharmaceuticals’ respiratory syncytial virus antiviral reduced the viral load in a phase 2 study in children, maintaining hopes the biotech can find a niche in a market now dominated by Big Pharma. |
By James Waldron Vivoryon Therapeutics’ glutaminyl cyclase inhibitor has failed a second phase 2 Alzheimer’s disease study this year, leaving the German biotech to try to find a silver lining in the drug’s potential to improve kidney function. |
By Gabrielle Masson VC Dimension has closed a $500 million fund for entrepreneurs that are “pioneering at the vanguard of life sciences and technology." |
By Nick Paul Taylor Merck & Co. has shown off data on its ROR1-directed antibody-drug conjugate, trumpeting a 100% complete response rate but also reporting safety signals that informed the decision to take the low dose into phase 3. |
By Angus Liu Trying to break from the decade-old practice of using BTK inhibitors indefinitely to treat blood cancer, AstraZeneca has positive data suggesting two fixed-duration combinations containing its Calquence can work in newly diagnosed chronic lymphocytic leukemia. |
By Kevin Dunleavy Merck hasn’t had much luck pairing cancer superstar Keytruda with PARP inhibitor Lynparza. But after flunking three clinical trials with the combination, the company has emerged with a tepid win with the pairing hitting the primary endpoint in an ovarian cancer study. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we explore the biotech IPO market rebound and ask: Is the momentum here to stay? |
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| WhitepaperWe 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 |
| WhitepaperExplore 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 |
| WhitepaperThe 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 |
| WhitepaperLearn 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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