| This week's sponsor is TD2. | | | The Quick-Start Guide to Clinical Strategy for Oncology Trials
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Today's Rundown Venter to leave Human Longevity as turnover at the top continues Sage postpartum depression drug gets priority review at FDA, teeing up 2018 approval Crescendo cuts psoriasis drug deal with China’s Zai Labs Northwest Bio's long-awaited glioblastoma vaccine data see stock roller coaster AzurRx brings on longtime drug developer James Pennington as CMO Titan, Braeburn end licensing deal for implanted drug for opioid addicts WuXi AppTec warns traders to cool off after 6-fold stock price increase in 3 weeks Featured Story | | | Wednesday, May 30, 2018 Craig Venter, Ph.D., is leaving Human Longevity Inc. Venter’s decision to step down as CEO and return to research at the J. Craig Venter Institute continues the turnover at the top of HLI, which has now lost two CEOs and a CMO in the past six months. |
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| This week's sponsor is Catalent. | | | |
Top Stories Wednesday, May 30, 2018 The FDA has awarded priority review designation to Sage Therapeutics’ postpartum depression drug brexanolone. Securing the status positions Sage to receive a decision from the FDA by the end of the year. Wednesday, May 30, 2018 Just weeks after closing a $70 million second-round financing, U.K. biotech Crescendo Biologics has signed another partner for its slimline antibody-like drug candidates, this time outside its core cancer focus. Wednesday, May 30, 2018 Northwest Bio unveiled interim phase 3 data showing its dendritic cell vaccine improved survival rates in patients with newly diagnosed glioblastoma. Its low-cost stock shot up 35% on the news, but then fell nearly 10% after-hours. Wednesday, May 30, 2018 James Pennington has joined AzurRx BioPharma as its chief medical officer as the company aims to launch a phase 2 clinical trial of its lead candidate in cystic fibrosis later this year. During his time as Bayer’s VP for biological clinical research in the late '90s, Pennington helped secure 10 FDA approvals and 10 approvals overseas. Wednesday, May 30, 2018 Titan Pharmaceuticals and Braeburn are parting ways over an opioid treatment licensing deal inked in 2012. Tuesday, May 29, 2018 WuXi AppTec reminded traders to consider the risks of investing in CROs after its stock price increased by the daily maximum of 10% for 15 straight trading sessions following its Shanghai IPO earlier this month. That vaulted its market cap to over $21 billion. | This week's sponsor is ExL Events. | | | |
Resources 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. Presented by: Patheon There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. In this article, the author discusses the choices available and strategies which can be employed at the different stages of development. Sponsored by: Veeva Systems Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems. Sponsored by: Veeva Systems UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off. Sponsored by: Veeva Systems Find out how to eliminate regulatory’s tracking spreadsheets for good. Sponsored by: Veeva Systems Learn how cloud-enabled solutions provide real-time insights and actionable analytics to improve clinical trial safety and performance in this short presentation. 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 Building your Program for Immunomodulating Therapeutics Wednesday, 6 June, 2018 | Paris, France Innovation, Collaboration and Entrepreneurship in Drug Discovery June 28, 2018 | Cambridge, UK BIO International Convention June 4-7, 2018 | Boston, MA
FierceBiotech Executive Breakfast at BIO 2018 – CAR-T 2.0: Innovation Never Stands Still June 6, 2018 | Boston, MA The Liquid Biopsy Summit June 20–22, 2018 | San Francisco, CA Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 