This week's sponsor is Premier Research. | | Placebo Response: Mitigating the Threat to Pain Trials Fibromyalgia Awareness Day, May 12, is a timely reminder of how placebo response can skew analgesia clinical trials. Our placebo problem eBook can help you take the pain out of pain trials. Premier Research. It's what we do. Best. | Today's Rundown Celldex plans life after glembatumumab, cutting 2 more drugs from pipeline In split vote, FDA advisory committee backs Akcea/Ionis’ volanesorsen Ziopharm hits pause on planned pivotal brain cancer trial [Sponsored] Optimize Human Gene Transfer Trials: Create Efficiencies with Coordinated IRB & IBC Review Faron fingers low bioactivity as possible cause of phase 3 flop Semma names former Novartis, Magenta executive as new CEO Mayo Clinic and AliveCor use AI to detect ‘invisible’ heart condition EuroBiotech Report—Autolus IPO, Abcam-Horizon, Faron fail, Promore and Pluristem FiercePharmaAsia—Takeda-Shire reach finish line, Hong Kong prerevenue IPO, AstraZeneca’s asset sale Chutes and Ladders—Atara hires ex-Genentech SVP to lead R&D Featured Story | Friday, May 11, 2018 Still reeling from the failure of its lead breast cancer candidate glembatumumab vedotin last month, Celldex has culled another two pipeline projects and now says it will focus its R&D efforts mainly on two cancer antibodies. |
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| This week's sponsor is Deloitte. | | | Top Stories Thursday, May 10, 2018 An FDA advisory committee voted 12-8 on Thursday to recommend the approval of Akcea Therapeutics’ volanesorsen, an RNAi drug for rare lipid disorder familial chylomicronemia syndrome. Friday, May 11, 2018 Ziopharm Oncology has hit pause on a planned pivotal trial of Ad-RTS-hIL-12 in brain cancer patients. Management took the action after technical issues slowed progress of the inducible adenoviral vector. Monday, May 7, 2018 Avoid delays in gene transfer trial start-up with tips from leading IRB and IBC experts. Friday, May 11, 2018 Faron Pharmaceuticals has zeroed in on low levels of interferon-beta bioactivity to explain why its phase 3 traumakine trial failed comprehensively. The biotech is now testing product batches to assess whether the formulation is to blame for the lackluster data. Thursday, May 10, 2018 Regenerative medicine developer Semma Therapeutics is bringing on Bastiano Sanna, formerly of Novartis’ cell and gene therapy unit and Magenta Therapeutics, to serve as its president and CEO following a $114 million funding round late last year. Friday, May 11, 2018 Investigators from the Mayo Clinic and AliveCor demonstrated that a trained artificial intelligence network can help identify people at increased risk of arrhythmias and sudden cardiac death, despite displaying a normal heart rhythm on their electrocardiogram. Thursday, May 10, 2018 In this week's EuroBiotech Report, Autolus files for a $100 million IPO, Abcam drops its Horizon buyout plan, Faron drug flunks phase 3 and more. Friday, May 11, 2018 After shaking hands with Shire on a $62 billion merger deal, Takeda lays out a plan for major cuts; Ascletis becomes the first company to file for an IPO under Hong Kong Exchange's revised listing rules for prerevenue biotechs; AstraZeneca offloads Seroquel rights to China's Luye Pharma; and more. Friday, May 11, 2018 Atara hires ex-Genentech SVP to lead R&D, Semma names former Novartis CAR-T developer as CEO and GSK's CFO heads for the exit. Read about those moves plus more hirings, firings and retirings throughout the industry. This week's sponsor is LabConnect. | | SciOps Provides Solutions for Lost Samples, Missed Timelines and Scientific Personnel Needs Managing outsourced studies can be challenging. Read how our team’s functional and strategic resourcing services allow you to focus on other core competencies. | 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. Sponsored by: USDM Life Sciences What are the biggest trends in life sciences this year? 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 Explore a new model for events management, and learn how to deliver more value. Sponsored by: Veeva Systems To deliver value to key opinion leaders, medical affairs needs to tailor their engagement with deeper analytics and insights. Sponsored by: Veeva Systems Learn how leading companies, from the world’s top pharma to emerging biotechs, are empowering their medical affairs teams. 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 Translational Biomarkers: Advancing Neuroscience Drug Discovery and Development May 14, 2018 | South San Francisco, CA
MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel Drug Development Immersion May 17-18, 2018 | Boston, MA 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 BioBasics: Biotech for the Non-Scientist June 13-14, 2018 | Toronto, Canada BioBasics: Biotech for the Non-Scientist June 13-14, 2018 | West Windsor, NJ Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA 18th International Biotechnology Symposium and Exhibition August 12-17, 2018 | Montreal, Canada 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! |