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In silico trials are emerging as an alternative to randomized controlled trials for rare diseases, particularly where no standard of care exists, or placebo is unethical. Download our whitepaper to learn more about this transformative approach.
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Today’s Big NewsNov 13, 2024 |
| By Nick Paul Taylor A hidden tab in an Excel spreadsheet published nine months ago has wiped $12 billion off Amgen’s market cap. The tab contains data on bone density changes in patients who received Amgen’s obesity prospect MariTide in a phase 1 trial. |
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By Nick Paul Taylor BioNTech is upping its bet on a PD-L1xVEGF-A bispecific, paying $800 million upfront to buy its Chinese partner Biotheus and secure full rights to a leading prospect in the white-hot immuno-oncology space. |
By James Waldron Metsera is riding the wave of continued enthusiasm for GLP-1 drugs and its own early-stage data to bring in a hefty $215 million series B fundraise. |
Sponsored by IO Biotech Making the tumor microenvironment hostile to cancer cells and immune-suppressive cells may transform the cancer treatment landscape. |
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Experience how our CMC and regulatory capabilities help achieve seamless, timely launches. Give your molecule the best chance of success. Start today.
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By James Waldron The agency has placed a partial hold on the phase 2a PORTOLA trial evaluating the selective immunoproteasome inhibitor zetomipzomib in 24 patients with autoimmune hepatitis |
By Nick Paul Taylor Syros Pharmaceuticals’ blood cancer prospect tamibarotene has failed another study, triggering a default on a loan and wiping 85% off the share price of the beleaguered biotech. |
By Gabrielle Masson After laying off all nonessential workers and halting nonessential R&D work this summer, Entero Therapeutics is inking a reverse merger with antibody drug conjugate (ADC) rival biotech Journey Therapeutics. |
By James Waldron Ovid Therapeutics is pumping the brakes on a planned phase 2 trial for its ROCK2 inhibitor in a type of brain lesion while it considers any lessons to be learned from the mixed readout of Recursion’s rival candidate. |
By Darren Incorvaia While awaiting an FDA decision for its small molecule revumenib in one form of acute leukemia, Syndax Pharmaceuticals is trying to build a case for its candidate in another. Though the drug met its primary endpoint in the phase 2 portion of a phase 1/2 trial, the results failed to impress investors, sending Syndax’s stock down 22%. |
By Gabrielle Masson There’s a new Muse in town. Sanofi, Formation Bio and OpenAI have joined forces to build an AI-powered tool designed to improve drug development by speeding up clinical trial recruitment. |
By Gabrielle Masson,Annalee Armstrong,Darren Incorvaia,Max Bayer Welcome to Fierce Biotech's Fundraising Tracker, 2024's version. |
By Gabrielle Masson Insilico Medicine plans to push its computer-designed drug into pivotal clinical trials after a phase 2a study demonstrated improvements in a respiratory health measure for patients with idiopathic pulmonary fibrosis. |
By Angus Liu The current FDA commissioner said that Trump’s first FDA head, Scott Gottlieb, was the perfect choice at the time. |
By Darren Incorvaia Medable is bringing generative AI into its clinical trial platform in hopes that the tech will reduce the burden of repetitive tasks on trial sponsors, the company announced in a Nov. 12 release. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we take a closer look at this year’s biotech graveyard, which tracks biotechs that have closed or are winding down. |
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| 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 |
| 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 |
| WhitepaperThis e-book explores 7 factors that are critical to the success of emerging biopharma companies, whether they plan to out-license, partner, or launch & commercialize products. It’s an essential resource for emerging companies with products in all stages of development. Sponsored by: Blue Matter |
| WhitepaperUnlock the secrets to faster, cost-effective biologics production with intensified biomanufacturing – download the whitepaper and power up your bioprocessing game! Sponsored by: Syngene International Ltd. |
| WhitepaperDiscover how independent adjudication can safeguard your clinical trials from misidentified adverse events and enhance the credibility of your results. Sponsored by: WCG |
| 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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