Sanofi, GSK push COVID-19 vaccine data into 2022. Will strong booster data hold their place in line? Lilly to kick off 2022 with completion of much anticipated FDA filing for Alzheimer's candidate AbbVie ends enrollment in Idera collab as the biotech winds down its own colorectal cancer trial Sponsored: 7 Applications for Formalin-Fixed Paraffin-Embedded (FFPE) Tissue Specimens Lilly packs up ulcerative colitis med for FDA with phase 3 success after ditching psoriasis After Roche bails, Atea will try to pair failed COVID-19 drug with other compounds Biopharma charts progress in translating CAR-T cell therapies to solid cancers Novartis cuts ties with Mesoblast's failed COVID-19 cell therapy as biotech tries for pivotal phase 3 Turns out Galera's radiotherapy complication drug did work after all, and investors are thrilled Generation Bio shares halved as hemophilia gene therapy hunt goes back to square one Sayonara, San Francisco. #JPM22 is going virtual, thanks to COVID Medtronic receives FDA warning letter over quality control issues at diabetes HQ Remote care management startup Cadence hits $1B valuation with $100M series B Featured Story | By Annalee Armstrong Sanofi and GlaxoSmithKline are delaying booster data for their combined COVID-19 vaccine into the first quarter of 2022, a readout that has been eagerly anticipated by investors and analysts. read more |
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Top Stories By Annalee Armstrong Eli Lilly is upping the ante in the race for the next Alzheimer’s treatment by scheduling its completion of a rolling regulatory submission for the first quarter of 2022. read more By Kyle LaHucik Idera Pharmaceuticals will no longer enroll patients in a midstage study of its drug in colorectal cancer, and AbbVie decided to do the same in an early stage test in head and neck cancer. read more Sponsored by: Precision for Medicine As technologies and methodologies advance, so do the potential applications for biospecimens. In this article, we explore seven uses of FFPE, ranging from the common to the cutting-edge. read more By Kyle LaHucik Eli Lilly will ask the FDA to approve its IL-23 drug mirikizumab in ulcerative colitis next year after passing a phase 3 test in the inflammatory bowel disease. read more By Annalee Armstrong After getting ditched by Roche a month ago, Atea is laying out a path forward for a failed COVID-19 med called AT-527, including a plan to conduct combination studies. Back in November, Roche cut ties on a $350 million deal with the small biotech after the drug failed to live up to expectations in the clinic. read more By Arlene Weintraub Several startups are raising interest—and dollars—to support innovative strategies for developing cell therapies to treat solid tumors. But their task is far from easy, with a combination of logistical hurdles and safety issues threatening to slow their progress. read more By Kyle LaHucik Novartis has canceled an agreement with Mesoblast on a failed COVID-19 cell therapy just as the Australian biotech tries to get a new phase 3 trial off the ground in the hopes the FDA will give the candidate another shot. read more By Annalee Armstrong Galera’s shares were pummeled in the wake of news that its radiotherapy complication drug flunked a phase 3 study, but now the biotech says the study results were in error, and the treatment did, in fact, work. read more By Annalee Armstrong Generation Bio’s shares were briefly halted Tuesday morning on the release of mouse data that complicated its search for a viable target for hemophilia A to take into the clinic. read more By Eric Sagonowsky Cancelled flights and hotel rooms have become par for the course during the COVID-19 pandemic. Now, with less than a month to go until the J.P. Morgan healthcare conference in January, the event organizers have pivoted to a virtual event, triggering another round of cancelled travel plans. read more By Andrea Park The warning letter was the result of an inspection of the Southern California facility that the FDA completed in July, related to a pair of Class I recalls issued for several models of Medtronic’s MiniMed insulin pumps. read more By Rebecca Torrence Digital health startup Cadence, which offers a remote care management platform for patients with chronic conditions, landed $100 million in series B funding just three months after its launch. read more Resources Sponsored by: WIRB - Copernicus Group Sites receiving augmentation support enroll more than 30,000 patients in just over three months. See how additional site resources can make a difference. Sponsored by: BBK Worldwide New survey results and insights help clinical trial sponsors improve diversity and inclusion, enroll faster, and keep participants engaged longer. Sponsored by: GLG A major Korean biopharmaceutical company wanted to gather unbiased opinions on a new cancer treatment product. Fill out our form to learn more. Sponsored by: GLG Download now to learn how GLG helped a biotech company plan for the demand of a new drug/device combination by commissioning a forecasting study. Sponsored by: Thermo Fisher Scientific A variety of genetic analysis methods are valuable in ensuring that ex vivo human cells to be used for cell-based therapies are correctly identified, have the correct characteristics, and are free of contaminants. Sponsored by: Thermo Fisher Scientific Learn how a CDMO partnered with Thermo Fisher Scientific to manage high-volume process liquid and buffer preparation scale-up. Download the free case study from Thermo Fisher Scientific Sponsored by: Clario This whitepaper addresses where AI can make the biggest impact in clinical trials. The stakes are too high for patients to leave decision-making to machines, but AI can lend administrative support that empowers staff and medical experts alike to carry out their jobs more effectively. Sponsored by: Medable, Inc. Find out how to improve clinical protocol adherence, and thus patient outcomes, by 15%+ with Medable’s latest White Paper. Sponsored by: IQVIA Learn how to elevate your omnichannel marketing strategy with Next Best - a combination of data and analytics, deployed to facilitate decision making. 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. Sponsored by: Informa Pharma Intelligence and Oracle Health Sciences New market research provides valuable insight into the impact of adaptations made in clinical trials during the pandemic. Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Fierce JPM Week 2022 January 11, 2022 | San Francisco, CA
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