| This week's sponsor is Premier Research. | | | New Insights in the Battle Against Alzheimer’s
Thanks to awareness efforts like World Alzheimer’s Day this Friday, there’s a relentless focus on finding breakthrough therapies for this ravaging disease. Our new white paper looks at how we’re combating this growing epidemic. Premier Research. It’s what we do. Best. |
Today's Rundown Racing UCB and Roivant, Argenx clears phase 2 in primary immune thrombocytopenia CRISPR Therapeutics, ViaCyte team up on gene-edited diabetes treatment FDA lifts clinical hold from Mersana’s breast cancer trial [Sponsored] Six Practices of High Performing Clinical Research Sites Realm surrenders after back-to-back clinical defeats Epic Sciences gathers $52M for blood tests that match cancer patients to therapies Featured Story | | | Monday, September 17, 2018 Argenx has posted phase 2 data on efgartigimod in primary immune thrombocytopenia. The results hint at the efficacy of the antibody Fc fragment in patients with the autoimmune bleeding disorder, leading Argenx to commit to running a phase 3 in the indication. |
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Top Stories Monday, September 17, 2018 CRISPR Therapeutics is partnering with ViaCyte to develop off-the-shelf, gene-edited stem cell therapies for diabetes in a deal worth up to $25 million. Monday, September 17, 2018 The FDA has lifted the partial clinical hold it placed on a phase 1 trial of Mersana Therapeutics’ HER2-targeted antibody-drug conjugate. Regulatory officials put enrollment in the XMT-1522 breast cancer trial on hold in July after learning of the death of a participant. Monday, September 17, 2018 Clinical research sites have a tough, but critically important, job. It’s rigorous and precise work, but essential to the progress of medicine. Monday, September 17, 2018 Faced with a pair of phase 2 failures, Realm Therapeutics has abandoned the platform that underlies all its drug development programs and engaged advisers to look into a possible sale. Monday, September 17, 2018 Cancer blood test company Epic Sciences brought in $52 million to advance its suite of liquid biopsies, which use computer vision and machine learning to identify circulating tumor cells while characterizing the body’s immune response at the same time, toward regulatory approval. | This week's sponsor is the Fierce Innovation Awards – Life Sciences Edition. | | | |
Resources Sponsored by: Veeva A top 20 pharma and growing biotech re-engineer regulatory processes. Sponsored by: Covance FSPx Covance FSPx boasts one of the world’s largest dedicated FSP groups in the contract research organization space with ~4200 staff in 60+ countries. Sponsored by: Covance FSPx Covance FSPx boasts one of the world’s largest dedicated FSP groups in the contract research organization space with ~4200 staff in 60+ countries. Sponsored by: Sciformix Are automation, big data and artificial intelligence (AI) a key part of your company’s pharmacovigilance strategy? Read this whitepaper to know what they should be! Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. Sponsored by: Patheon, part of Thermo Fisher Scientific When developing a parenteral, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. Sponsored by: Baxter Baxter BioPharma Solutions’ whitepaper offers a method to address the challenges of tech transfer for lyophilized products from lab-scale to commercial-scale. Sponsored by: Blue Matter A whitepaper outlining the key commercial challenges facing rare disease products, and how biopharmaceutical companies can overcome them. Sponsored by: AWS and Tableau Inova is using the capabilities of Tableau on AWS to identify biomarkers for personalized treatment intended to improve health outcomes for children. Sponsored by: AWS and Reltio Reltio and IQVIA provide holistic data management solutions for traditional pharma, emerging biotech, and consumer health companies, on AWS. Presented by: AWS and Druva Life Sciences organizations are embracing cloud-based Master Data Management (MDM) to modernize the organization of critical data. Sponsored by: Health Strategies Group The window of market exclusivity continues to narrow dramatically in the global marketplace. Given this demanding environment, your global market access team faces increasing urgency to get the value proposition right at the time of launch. Sponsored by: PharmaCord When was the last time your patient support program perfectly aligned with the patient journey, solving all the critical gaps in positioning your brand for success? Follow the 3-D approach to your solution design, and you will achieve a better outcome for your patients. Sponsored by: Catalent Develop a basic understanding of principles and concepts of bioavailability of oral drugs. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Drug Development Boot Camp® 2018 – Registration closes 30 October - Register Now! November 14-15, 2018 | Boston, MA | Registration closes on the 30 of October 2018 due to the need for participants to complete pre-Boot Camp preparations. Register now and start preparing for this intensive training in drug development. 2018 Latin America Healthcare Compliance Certification Program September 24-27, 2018 | Sao Paulo, Brazil FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Compliance Certification Program at Seton Hall Law October 8-11, 2018 | Newark, NJ BioImmersion: Biotech for the Non-Scientist October 16-18, 2018 | Chicago, IL Fierce Innovation Awards: Life Sciences Edition 2018 FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Understanding Commercialization Within Biopharma Nov 7-8, 2018 | Boston, MA Drug Development Immersion December 5-6, 2018 | San Diego, CA Understanding Drug Pricing and Reimbursement December 12, 2018 | Boston, MA | 