Pfizer's $7B ulcerative colitis drug racks up another phase 3 win, laying the groundwork for approval filings Sanofi pulls IGM into dealmaking whirlwind, paying $150M upfront to form 6-target R&D pact ImmunoGen files ovarian cancer ADC with FDA, a week after scaring investors with iffy survival data Sponsored: How creative chemistry and collaboration synthesized a better drug strategy for Enterin Biden seeks $2.1B funding boost for FDA, part of pan-agency pandemic preparedness plan Cuts to the Bone: Orthopedic biotech slashes C-suite, overhauls entire pipeline On a roll, Sanofi raises Dupixent's peak sales target to €13B-plus THREAD Research, Amazon Web Services partner on new automations for decentralized clinical trials LetsGetChecked expands at-home testing with bid for George Church's Veritas companies Tenet Healthcare's Saum Sutaria brought home $21.2M during his first year as CEO Producing faster CAR-T cell therapy inside the body with a spongelike implant HHS is investigating how consumers are marketed accelerated approval drugs Carl June, Penn's latest CAR-T work taps llamas to home in on gastrointestinal tumors Featured Story | By Nick Paul Taylor The wins keep coming at Pfizer. Six days after posting positive induction data on its $6.7 billion ulcerative colitis drug, Pfizer has reported the S1P receptor modulator improved clinical remission out to 52 weeks in a second maintenance phase 3 clinical trial. read more |
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Top Stories By Nick Paul Taylor Sanofi has continued the breakneck pace of dealmaking activity, paying $150 million upfront to make IGM Biosciences the third partner added in a hectic month for its business development team. read more By Annalee Armstrong Last week, ImmunoGen’s investors scattered on underwhelming survival data from a late-stage trial of its antibody-drug conjugate for ovarian cancer. But that was last week. This week, the company is filing an application for FDA approval based on the “positive results.” read more Sponsored by: Pfizer Reshaping the understanding of enteric nervous system (ENS) dysfunction and the progression of Parkinson’s, Pfizer CentreOne helped Enterin synthesize a better chemistry for its lead candidate. read more By Annalee Armstrong The Biden administration has proposed a $2.1 billion boost in funding for the FDA in 2023 to support the Cancer Moonshot program and pandemic preparedness. In total, the FDA could be up for $8.39 billion, a 34% increase over the $6.25 billion enacted for 2022. read more By Max Bayer Bone Therapeutics is cutting its executive team to the...you guessed it...in an attempt to weather a cost-cutting storm and refocus the company on a lead “off-the-shelf” cell therapy platform. read more By Eric Sagonowsky Over the years, as Sanofi and Regeneron's Dupixent racked up new indications and approached the French pharma giant's 10 billion euro peak sales goal, analysts had started to wonder whether the drug might end up overshooting the target. With Dupixent now well on the way, Sanofi is raising its peak sales ambitions on the star drug to more than 13 billion euros. read more By Gabrielle Masson THREAD Research, a company focused on supporting decentralized clinical trials, will work with Amazon Web Services to decrease trial costs while improving research access and data quality. read more By Andrea Park In side-by-side acquisitions, LetsGetChecked has struck a pair of deals to buy Veritas Genetics and Veritas Intercontinental, which share the at-home testing company’s mission of expanding access to comprehensive health screening. read more By Dave Muoio Tenet healthcare CEO Saum Sutaria, M.D., improved on the $8.6 million and $14 million he claimed in 2020 and 2019 under his prior titles of president and chief operating officer. read more By Angus Liu CAR-T therapies are expensive thanks partly to complex and lengthy manufacturing procedures. Now, scientists have found a potential way that could cut the CAR-T processing time from more than two weeks to a single day by using an implant. read more By Sharon Klahr Coey Hot on the heels of backlash of the accelerated approval of Biogen’s Alzheimer’s disease drug Aduhelm, the Department of Health and Human Services' FDA is looking to rethink and redirect how these speedier approvals are marketed to consumers. read more By Angus Liu Scientists at the University of Pennsylvania have identified a cell surface protein that, despite its expression on both healthy and tumor cells, could be leveraged for CAR-T therapy against hard-to-treat gastrointestinal cancers and neuroendocrine tumors. read more Resources Sponsored by: H1 Read why many MSLs are still challenged in developing integrated strategies to increase the volume of meaningful engagements. Download this industry report to find out what the top challenges are and suggestion strategies to solve them. Download now. Sponsored by: Medidata, a Dassault Systèmes company The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates. Sponsored by: Thermo Fisher Scientific Learn how to navigate the top manufacturing challenges and achieve a seamless transition from discovery to clinical manufacturing across the CAR T-cell therapy workflow. Sponsored by: Oracle Health Sciences Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research. Sponsored by: Oracle Health Sciences How to overcome top challenges faced in decentralized trials. Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. 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