This week's sponsor is Premier Research. | | Placebo Response: A Real Threat to Pain Trials Rising placebo response rates skew analgesia clinical trial data and limit treatment options for suffering patients. Learn how to manage this pain point in analgesia trials with our free eBook. Premier Research. It's what we do. Best. | Today's Rundown Biogen bails on AGTC after ocular gene therapy flunks trial Amag merges with Perosphere, adding NOAC antidote FDA hails 2018 as bumper year for drug development successes [Sponsored] Mining Real-World Data With Cutting-Edge Analytical Tools Biofrontera cleared of wrongdoing in Nasdaq IPO Sunovion, PsychoGenics nondopamine schizophrenia drug meets phase 2 endpoint NeuroRx plans pivotal trial after seeing hints of efficacy in suicidal patients Featured Story | Thursday, December 13, 2018 Applied Genetic Technologies’ $1 billion-plus gene therapy pact with Biogen has been torn up after their lead candidate failed a phase 1/2 trial. |
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| Top Stories Thursday, December 13, 2018 Amag Pharma has struck a merger deal with Perosphere, adding an anticoagulant reversal agent in midstage trials to its emerging hematology business. Thursday, December 13, 2018 The FDA has hailed 2018 as a standout year for drug development and approvals, both in terms of the quantity and quality of activity. With the FDA approving 55 new molecular entities over the first 11 months of the year, 2018 has eased past 1996 to become the busiest year ever. Perhaps more importantly, the FDA thinks there are plenty of important drugs in the class of 2018. Monday, December 10, 2018 In 1848, the most famous Gold Rush in American history began at Sutter's Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for many, a shattered dream. Thursday, December 13, 2018 An independent review has cleared Biofrontera of wrongdoing related to its U.S. IPO. Shareholders had accused Biofrontera of acting contrary to its duties when it priced and sold stock in the U.S. Thursday, December 13, 2018 Sunovion Pharmaceuticals and PsychoGenics unveiled positive phase 2 results for a new schizophrenia treatment that does not bind to the brain’s dopamine receptors. Thursday, December 13, 2018 NeuroRx is planning to move NRX-101 into phase 2b/3 after detecting signs of efficacy in a feasibility trial in patients with suicidal bipolar depression. The small phase 2 feasibility study linked fixed-dose combination NRX-101 to improved scores on a depression rating scale. Resources Sponsored by: DocuSign Life sciences companies must immediately identify and realize productivity gains to drive down operational costs—or risk seeing more nimble competitors disappear into the distance. Where to begin? Sponsored by: Veeva Learn how to spot an imposter with an integrated suite vs. one that’s unified. Read this whitepaper to learn more. Sponsored by: Patheon, part of Thermo Fisher Scientific Read this whitepaper to learn how the biologics market is quickly evolving and how these changes pose several risks to a molecule’s success. Sponsored by: Coupa Software Learn how Becton Dickinson implemented Coupa to create an easy-to-use purchase to pay process that increased efficiency across the organization. Sponsored by: Almac Diagnostic Services, part of the Almac Group Download the whitepaper to learn more. Sponsored by: Reprints Desk, Inc. Learn how to fast-track your research workflows! Sponsored by: Veeva Industry Research: Read the 2018 Unified Clinical Operations Report to find out how pharmas and CROs are evolving clinical trial processes. Sponsored by: Applied BioMath This on-demand webinar introduces a quantitative systems pharmacology (QSP) model of targeted anabolic growth factors for intra-articular injection for the treatment of diseased joints. Sponsored by: Oracle Health Sciences New research reveals more than 50% of clinical data management professionals surveyed, are not confident in the quality and completeness of their clinical trial data. Sponsored by: Veradigm New Case Study – Leveraging Real-World Evidence From EHR to Assess Migraine Management Sponsored by: Signals Analytics What does data tell us about the future of cell & gene therapy? Sponsored by: Outer Edge Technology Outer Edge Technology specializes in designing and managing regulated cloud-based infrastructures for the Life Sciences Industry – typically leveraging the AWS and Microsoft Azure platforms. 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. Drug Approval, Manufacturing Quality & Regulation 2018 | Online FierceBiotech Executive Breakfast at the J.P. Morgan Healthcare Conference 2019 January 8, 2019 | The Fairmont Hotel | San Francisco, CA Phacilitate Leaders World 2019 January 22-25, 2019 I Hyatt Regency, Miami Asia-Pacific Compliance Training for Life Sciences Professionals March 4-7, 2019 | Singapore |