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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 11, 2024 |
| By Nick Paul Taylor A phase 3 prostate cancer trial of Candel’s oncolytic virus has met its primary endpoint, sending the stock up more than 200%. The phase 3 hit was offset by the failure of a midphase study. |
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By Darren Incorvaia Chroma Medicines and Nvelop Therapeutics are fusing their names and science to launch nChroma Bio along with the backing of a $75 million fundraising round led by Cormorant Asset Management, Arch Venture Partners, Atlas Venture and Newpath Partners. |
By James Waldron Cellectar Biosciences is laying off 60% of its employees and halting work on its sole clinical-stage radiotherapy after the company received feedback from the FDA that a fresh study would be required before approval. |
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 Q32 Bio still sees potential for its anti-IL-7R antibody as an alopecia treatment despite failing a phase 2 eczema study—but investors appear unconvinced. |
By Darren Incorvaia AnaptysBio is dropping its atopic dermatitis drug candidate after the compound failed to reduce eczema area and itch severity in a phase 2b trial, missing all of its endpoints. |
By James Waldron Spruce Biosciences has trimmed the only drug from its pipeline in the wake of a second phase 2 trial this year, leaving the biotech’s future direction in doubt. |
By Angus Liu It looks like Eli Lilly’s oral selective estrogen receptor degrader (SERD) imlunestrant may need some extra help to reach a broad patient population with ER-positive, HER2-negative breast cancer. |
By James Waldron Less than a year after completing a series B extension round, Angitia has set its sights even higher with a $120 million series C that the biotech will use to push its three musculoskeletal candidates through ongoing trials. |
By Gabrielle Masson A jury has convicted both former CytoDyn CEO Nader Pourhassan, Ph.D., and ex-Amarex CEO Kazem Kazempour on several charges tied to defrauding biotech investors. |
By Nick Paul Taylor BenevolentAI has begun a “significant organizational restructuring” that will lead to layoffs. The company framed the changes as a return to “its founding TechBio mission” after years in which it aspired to be a fully fledged biotech with a wholly owned, late-phase pipeline. |
By Gabrielle Masson Cardiff Oncology’s investigational PLK1 inhibitor paired with standard-of-care treatment showed a 64% overall response rate (ORR) in the high-dose cohort of a midstage colorectal cancer trial. |
By Gabrielle Masson After receiving an unsolicited acquisition proposal from an unnamed Big Pharma in 2023, Poseida reached out to inform partner Roche of the offer, at which point the Swiss pharma said it wasn’t interested in buying the biotech at the time. |
By Fraiser Kansteiner President-elect Donald Trump on Tuesday nominated Andrew Ferguson to lead the U.S. Federal Trade Commission. Ferguson, who has promised to be tough on Big Tech while adopting a more agreeable stance around dealmaking in general, could bode well for a possible revival in biopharma M&A. |
By Paige Minemyer Walgreens is weighing a potential sale to a private equity firm, according to a report in The Wall Street Journal. |
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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