Today's Rundown Biogen, Eisai's anti-amyloid drug slows Alzheimer's decline, but debate rages on AstraZeneca’s selumetinib flops in thyroid cancer, adding to list of failures Quality blip halts Sarepta muscular dystrophy gene therapy trial [Sponsored] Q&A with Cardinal Health Regulatory Sciences: Navigating cell and gene therapies through clinical and regulatory hurdles New startup Convelo links old and new compounds to myelin repair in MS Two Athenex phase 3 trials show 100% skin clearance of precancerous lesions Gilead's top executives Milligan and Martin stepping down Featured Story | Thursday, July 26, 2018 Biogen and Eisai revealed data from an 800-patient trial showing their amyloid-fighting antibody significantly slowed cognitive decline and amyloid buildup in the brain. The findings are a first in a field rife with prospects that show early promise but fail to deliver in phase 3. |
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| This week's sponsor is FierceBiotech. | | | Top Stories Thursday, July 26, 2018 As it has been tussling over licensing checks and trying to gain a reprieve, AstraZeneca quietly announced in the midst of its quarterly update Thursday morning that selumetinib has once again missed the mark in a cancer test. Thursday, July 26, 2018 A phase 1/2a trial of Sarepta’s gene therapy for muscular dystrophy has been placed on clinical hold by the FDA but could be upgraded to a pivotal study as a result. Monday, July 23, 2018 Gene and cell therapies are at the cutting-edge of biomedical research, promising potentially curative options for a host of disorders such as forms of blindness, blood cancers and inherited diseases. Wednesday, July 25, 2018 With research from Case Western Reserve University, a Cleveland-based startup aims to develop a new class of medicines that help regenerate the insulating myelin sheath around nerve cells, which is degraded in neurological disorders such as multiple sclerosis. Thursday, July 26, 2018 Athenex reported that two phase 3 trials of its skin ointment for precancerous lesions saw 100% clearance of actinic keratosis growths within 60 days, including in the face and scalp. Wednesday, July 25, 2018 In a clean sweep, the two top executives at Gilead Sciences will step down at the end of this year, potentially setting the company up for an entirely new approach. This week's sponsor is IQVIA. | | | Resources Sponsored by: Veeva Industry Research: See new results from one of the industry's largest, global clinical operations surveys. Sponsored by: Veeva Ready to modernize your RIM environment? Secure buy-in with these tips. Sponsored by: Medidata Accelerate Clinical Research as Study Complexity Grows Sponsored by: Patheon, part of Thermo Fisher Scientific Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies. What should pharma companies look for when navigating this new era of small-volume manufacturing? Here are some ideas to consider when developing a new manufacturing strategy. Sponsored by: Veeva See results from the Tufts eClinical Landscape Study – CRO Report on current data management practices, goals, and challenges for contract research organizations (CROs). Sponsored by: Docusign Life science companies are experiencing a significant transformation in how they bring new products to market. Drug Approval, Manufacturing Quality & Regulation 2018 | Online The Life Science Women's Conference August 8-9, 2018 | Austin, Texas Join 200+ Service and Support Leaders at Field Service Amelia Island this August August 27-29, 2018 | Amelia Island, FL BIO Latin America 2018 September 4-5, 2018 | São Paulo, Brazil RESI HealthTech Week September 5-7, 2018 | Boston, MA 2018 Latin America Healthcare Compliance Certification Program Sao Paulo, Brazil | Sep 24-27, 2018 4th Annual Bio/Pharmaceutical Product Launch Summit September 25-26, 2018 | Cambridge, MA Drug Development Immersion September 26-27, 2018 | West Windsor, NJ FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA The Advanced Biologic Development Summit at Northeastern University October 9, 2018 | Boston, MA BioImmersion: Biotech for the Non-Scientist October 16-18, 2018 | Chicago, IL FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Drug Development Boot Camp® 2018 – Register Now! November 14-15, 2018 | Boston, MA | Register now and start your pre-Boot Camp preparation |