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Consumers are looking to improve their gut health and direct-to-consumer testing companies are investing in the opportunity. Discover key considerations and learn how to pick the best at-home fecal collection device in this free guide. Download Now.
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Today's Big NewsJan 26, 2023 |
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Phreesia Life Sciences surveyed more than 4,300 patients checking in for their doctors’ appointments to better understand their perceptions and
preferences around clinical trials. But what's the best way to reach them? View Infographic
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| By Nick Paul Taylor Magenta Therapeutics’ MGTA-117 blood cancer clinical trial has gone from bad to worse. Weeks after Magenta dropped down a dose level in response to serious adverse events (SAEs), a patient has died after receiving the new, lower dose, prompting the biotech to voluntarily pause the study. |
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By James Waldron As an FDA approval decision looms, Sanofi has unveiled more data from a phase 3 trial of its potential hemophilia A rival to Roche’s blockbuster Hemlibra. |
By Annalee Armstrong It’s early days for AC Immune’s Alzheimer’s disease vaccine, but a sneak peak at phase 1b/2 data showed the anti-amyloid beta vaccine elicited a response, allowing it to move up to a higher dose in the trial. |
Sponsored by Clarify Health We initiate a discussion focused on the relation of clinical trials and the need for geographical inclusion versus societal exclusivity. With some trial sites including only 20% of the disease population in the United States, innovation is needed. |
By Nick Paul Taylor Aridis Pharmaceuticals’ monoclonal antibody has flunked a phase 3 clinical trial of patients with bacterial infections. After stopping enrollment early because of COVID-19 and the war in Ukraine, the biotech failed to show AR-301 improves the rate of clinical cure but is nonetheless planning a second phase 3. |
By James Waldron Ocuphire Pharma’s diabetic retinopathy candidate missed the primary endpoint of a phase 2 trial, sending the company’s shares down over 25%. But the biotech has suggested that the drug’s effect on both eyes could still offer a path to FDA approval. |
By Max Bayer Sesen Bio is clapping back after a rival group of investors alleged they were bribed for their support for a planned merger with Carisma Therapeutics. |
By Gabrielle Masson South Korea-based GenKOre has inked a research collab worth up to $300 million to develop new in vivo gene editing therapies, the biotech’s second deal with a U.S.-based company announced this month. |
By Joseph Keenan The European Medicines Agency sent a letter of support for Critical Path Institute’s efforts to establish a model-based clinical trial simulation platform that could help find new treatments for Duchenne muscular dystrophy. |
By Fraiser Kansteiner Eyeing potential launches beyond its COVID-19 vaccine Spikevax, Moderna will hire roughly 2,000 new employees in 2023, the company recently told Fierce Pharma. That should bring the biotech’s total headcount to around 6,000 before the year is out, Jerh Collins, Ph.D., Moderna’s chief technical operations and quality officer, said in an interview. |
By Andrea Park Getinge has recalled nearly 8,800 heart devices after receiving more than 100 complaints about them, including one report of a patient death. |
By Anastassia Gliadkovskaya Private equity investment carries “unique risk,” the report argues. By prioritizing high returns and profits, firms may sacrifice staffing or reduce access to less profitable services that may still be of need to patients. |
By Fraiser Kansteiner There's been a yearslong will-they or won’t-they situation between England’s cost-effectiveness watchdog and Gilead’s Kite—as well as Novartis—for their respective CAR-T therapies. Now, Gilead has finally gotten the drug cost gatekeeper to warm up to its blood cancer cell therapy. |
By Joseph Keenan Kroger Health, a unit of the grocery chain Kroger Co., kicked off the opening of its clinical trial network by starting recruitment of patients for the group’s first trial for colorectal cancer gut and immune health observations. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we take you inside Fierce's JPM Week event. Listen in on snippets from a lively panel discussion on how companies will navigate the drug pricing policies the Biden administration rolled out just last year. And hear from Christine Roth, head of Bayer's oncology strategic business unit, about the company's plans to become a strong competitor in cancer. |
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March 14-15, 2023 | San Francisco, CA Be in the room with the life sciences industry leaders to forge new connections & take advantage of in-person networking opportunities. Register now to be in the room for this amazing networking opportunity!
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| WhitepaperRCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
| Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
| WhitepaperThis paper explores how Medical Affairs is adapting medical communications to meet the demands of a new environment (part 5 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences |
| On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
| Executive Summary Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more. Sponsored by: Catalent |
| Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| WhitepaperExplore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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