| This week's sponsor is Premier Research. | | | Rare Cancer Drug Research: What to Know Going In
Rare cancer drug research requires oncology and rare disease expertise and careful attention to trial design and regulatory demands. Get started with our white paper. Premier Research. It's what we do. Best. |
Today's Rundown FDA hits Ziopharm CAR-T trial with clinical hold Veteran analyst Eric Schmidt moves over to biotech as Allogene's new CFO Medivir delays pivotal HDAC trial as FDA discussions stall Solid Bio to resume DMD gene therapy trial after FDA lifts clinical holds Evotec seals deal for Sanofi’s infectious disease unit Gene therapy with ‘off switch’ restores hand movement in rats with spinal cord injury Feds charge Theranos’ Elizabeth Holmes with wire fraud Featured Story | | | Monday, June 18, 2018 The FDA has placed a clinical hold on Ziopharm Oncology’s phase 1 CAR-T trial. Ziopharm wants to run the study to assess CAR-T cells manufactured at the point of care, but the FDA is demanding more CMC information before allowing it to proceed. |
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| This week's sponsor is Catalent. | | | |
Top Stories Monday, June 18, 2018 Longtime Cowen analyst Eric Schmidt is joining Arie Belldegrun's latest CAR-T startup, Allogene, six weeks after he confirmed that he was considering a job offer from the company. Monday, June 18, 2018 A year ago, Medivir was riding high after reporting midstage data that encouraged it to press ahead with a pivotal trial of its HDAC inhibitor remetinostat in cutaneous T-cell lymphoma. The Swedish biotech has hit a snag, though—it can’t agree on a design for the study with the FDA. Monday, June 18, 2018 The FDA has lifted the second of two clinical holds on Solid Biosciences’ phase 1/2 trial in Duchenne muscular dystrophy, following the resolution of safety and manufacturing concerns, and the company has begun working to resume enrollment. Monday, June 18, 2018 Evotec has wrapped up a deal for Sanofi’s infectious disease unit. The agreement sees Sanofi transfer 100 employees, more than 10 drug candidates and €60 million ($70 million) upfront to the German service provider. Monday, June 18, 2018 Researchers from King’s College London designed a gene therapy that can be switched off once it has treated a spinal cord injury, addressing concerns of uncontrolled gene expression down the line. Monday, June 18, 2018 A federal grand jury has indicted Theranos CEO Elizabeth Holmes and former COO Sunny Balwani for several counts of wire fraud and conspiracy to commit wire fraud. Enrollment Showcase | | | Sponsored by: Bioinformatics at UTHealth SBMI UTHealth SBMI now offers a M.S. track in clinical and translational bioinformatics. |
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Resources Life Science Strategy Group Take this anonymous 10-minute survey to share your thoughts on leading eClinical technology solutions and earn up to $55 honoraria. Take the survey now! Sponsored by: Blue Latitude Health Blue Latitude Health explores the commercial barriers and new stakeholder connections for pharma companies developing precision medicines, and reveals how to grasp novel opportunities in the new era of healthcare. Presented By: Covance A solid RBM plan will not only help you comply with the ICH guidelines, but will help you mitigate risks which could ultimately delay your trials and increase costs. Download today! Presented by: Patheon, part of Thermo Fisher Scientific “Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure. Sponsored by: Seton Hall Law 4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics. 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 Innovation, Collaboration and Entrepreneurship in Drug Discovery June 28, 2018 | Cambridge, UK Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA The 16th Annual Discovery on Target September 25-28, 2018 | Boston, MA 10th International Leaders in Biobanking Congress October 14-16, 2018 | Cleveland, OH Drug Development Boot Camp® 2018 – Register Now! November 14-15, 2018 | Boston, MA | Register now and start your pre-Boot Camp preparation | 