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| Webinar: A Systems Model of Gene Therapy for Sickle Cell Disease Tuesday, November 30 | 2pm ET / 11am PT Stem cell gene therapy is an emerging experimental therapy for SCD with the potential for lifelong cure but it is an expensive multi-step treatment regimen. This webinar is ideal for scientists and decision makers in drug R&D who want to leverage systems pharmacology for drug discovery and development. Register Now. |
Featured Story | By Kyle LaHucik A patient has died in a Kura Oncology phase 1b trial in people with acute myeloid leukemia leading the FDA to place a clinical hold on the study. The investigational oral treatment was potentially associated with differentiation syndrome, an adverse event that the biotech's management said is "part and parcel of this mechanism of action." read more |
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Top Stories By Nick Paul Taylor Pfizer has reported top-line results on its $250 million antisense bet. The phase 2b clinical trial of the cardiovascular disease drug met its primary endpoint but, with Pfizer still considering next steps and yet to share data, it is unclear whether the asset can muscle in on a market targeted by Regeneron. read more By Nick Paul Taylor Acorda Therapeutics is losing another employee. After seeing colleagues depart in waves of layoffs in recent years, Acorda Chief Medical Officer Burkhard Blank is leaving to take up a position at Pharnext. read more Sponsored By: New Product Planning Summit Join us in person on December 1-2 in Boston, MA to become a part of this growing community of eager professionals who are navigating the New Product Planning space during these uncertain times. read more By Annalee Armstrong Fierce Biotech caught up with one of the scientists who spotted irregularities in Cassava’s research after the issue was flagged in a citizens petition to the FDA. read more By Kyle LaHucik Merck wants in on another immunotherapy program from its $695 million collaboration with Dragonfly Therapeutics. The biotech has been popular around Big Pharma in the past two months with Bristol Myers Squibb licensing its sixth drug from Dragonfly just last month. read more By Kyle LaHucik Inclusion of underrepresented groups in clinical trials has long been an issue in the drug development world, with minority populations comprising small percentages of studies supporting new drug approvals. Reify Health has released a new tool to help drug sponsors increase their diversity efforts in clinical trials. read more By Conor Hale On a quarterly earnings call with investors, Martha described the launch as currently holding in a “limited-release phase.” read more By Angus Liu Kymera Therapeutics showed its STAT3 degrader significantly inhibited tumor growth in mice bearing colorectal cancer and B-cell lymphoma. The drug also appeared to sensitize tumors to anti-PD-1 cancer immunotherapy. read more By Angus Liu As Sanofi's Pompe disease franchise fuels its growth in rare diseases, the company has inked a $180 million settlement related to a license for a key medicine. read more By Robert King UCB became the ninth drugmaker to cut off sales of 340B-discounted products to contract pharmacies despite an ongoing legal feud between several drugmakers and the federal government. read more Resources Sponsored by: TransPerfect Life Sciences If you’re thinking about leveraging the benefits of increased quality, reduced costs, and shortened turnaround times that machine translation (MT) has to offer, check out this quick guide for the top 10 considerations when implementing MT. 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: 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: 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: Blue Matter Consulting Paper describing how the chronic insomnia market offers big lessons for any biopharma company thinking about getting into digital therapeutics in any therapeutic area. 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 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: 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 Launch Readiness for Medical Affairs & Communications Teams December 1-2, 2021 | Boston, MA Learn how therapeutics are successfully launched and commercialized December 1-2, 2021 | Live & Online Fierce New Product Planning Summit December 1-2, 2021 | Boston, MA 2nd Annual Symposium on Translational Medicine and Biomanufacturing December 2—3, 2021 Fierce Virtual Clinical Trials Summit December 6-7, 2021 | Philadelphia, PA Fierce JPM Week 2022 January 11, 2022 | San Francisco, CA
January 18-20, 2022 | Virtual Event Virtual European Healthcare Compliance Certificate Program January 24-28, 2022 Fierce Drug Safety Summit February 8-9, 2022 | Arlington, VA Fierce Business Development and Licensing Summit March 2022 | San Francisco, CA Fierce Medical Affairs Strategic Summit (MASS) East April 2022 | New Jersey Fierce Health IT Summit April 20, 2022 | Virtual Event Fierce Trial Master File Summit May 2022 | Location TBD Fierce Promotional Review Committee Compliance and Best Practices Summit April 2022 | New Jersey Fierce Digital Pharma Innovation Week June 2022 | Virtual Event Fierce Biotech Next-Gen June 29, 2022 | Virtual Event Fierce Pharma PR & Communications Summit July 2022 | Location TBD (NYC Metro Area) Fierce Biotech Forum October 2022 | Location TBD Fierce Biotech Virtual Forum October 19, 2022 | Virtual Event | 
