Today's Rundown Astellas inks $3B Audentes buyout to expand in gene therapy 'Positive surprise' for Biogen in lupus, but all eyes on CTAD data this week FDA nixes Lexicon’s diabetes hopeful Zynquista—again [Sponsored] Thwarting Subjectivity in Clinical Trials Brii Biosciences nabs Icon, GSK veteran to lead new focus on neuroscience Biopharma vet Martin Williams takes the helm at autophagy biotech Caraway Therapeutics Ardelyx's kidney disease drug hits goal in phase 3, teeing it up for FDA filing Treating multiple sclerosis with the help of the gut microbiome The top 15 biopharma M&A mistakes of the last decade Featured Story | | | Tuesday, December 3, 2019 Astellas Pharma is set to buy Audentes Therapeutics for $3 billion. The deal will enable Astellas to set up a new genetic regulation unit spearheaded by a neuromuscular disease gene therapy that is set to be submitted for approval next year. |
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Top Stories Tuesday, December 3, 2019 Biogen is joining AstraZeneca on a strong positive for its lupus candidates as the pair face going head-to-head on the market. Tuesday, December 3, 2019 The FDA rejected Lexicon Pharmaceuticals and Sanofi’s Zynquista in March, dashing their hopes of launching the Type 1 diabetes drug this year. Nine months later, the agency has rebuffed Lexicon’s appeal of that decision. Along the way, Lexicon lost its partner, which in 2015 handed over $300 million upfront for a license to Zynquista. Monday, December 2, 2019 A clinical trial is a measurement system, but too often, we fail to calibrate the most significant of measurement instruments: trial participants. Tuesday, December 3, 2019 U.S.-China biotech Brii Biosciences is pushing out into new territory with a new hire alongside a focus on a new R&D area. Tuesday, December 3, 2019 Martin Williams, the GlaxoSmithKline and Roche alum who helmed Tokai Pharma and co-founded Yuma Therapeutics, has a new gig—he's now the CEO of Caraway Therapeutics, a biotech working on treatments for neurodegenerative diseases that target the cell’s garbage disposal. He joins as the company mulls indications for its lead program. Tuesday, December 3, 2019 A phase 3 trial of Ardelyx’s tenapanor in chronic kidney disease patients on dialysis has met its primary endpoint. The success comes months after tenapanor hit the mark in another pivotal clinical trial, putting Ardelyx on track to file for approval in the indication around the middle of next year. Monday, December 2, 2019 A team at Brigham and Women's Hospital discovered a microRNA in the microbiome that increases when multiple sclerosis peaks. When they gave a synthetic version of the microRNA to mice as an oral treatment, it suppressed symptoms of the disease. While many of the decade's M&A deals worked out for the buyers, others didn't deliver on their promises. Here, we feature 15 of those deals, including Bayer's Monsanto buy, Teva's purchase of Allergan's generics, AbbVie's Synageva pickup and many others. | | Experts in our field; with 20+ years’ experience in Viral Vector & plasmid DNA (R&D, High Quality and GMP) manufacture for pre-clinical, clinical & commercial supply. Take a virtual tour of our facilities & find out more about our expansion project. |
Enrollment Showcase | | | Sponsored by: University of Florida College of Pharmacy University of Florida precision medicine leaders highlight current knowledge and trends to advance the future of health care in this new webinar series. Register today. |
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Resources Sponsored by: Clarivate Analytics Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead. Sponsored by: Thermo Fisher Scientific Are you facing costly delays in your API scale-up? Sponsored by: Roche and IQVIA This global landscape study identifies and assesses innovative funding models for cancer and other high-cost chronic NCDs across Africa, Asia, Europe, Latin America and Middle East. The study aims to enable readers to better understand the possibilities that innovative funding models bring to bridge the current and future funding gap, while stressing the key success factors that enable sustainability and success such as stakeholder collaboration. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. Sponsored by: Amazon Web Services From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks Sponsored by: Outer Edge Technology, LLC See why visionaries outsource the design and management of the infrastructure allowing their scientists to innovate. Sponsored by: Veeva Systems Medical Affairs 2025 brings together leading perspectives from AstraZeneca, Bristol-Myers Squibb, Merck, Lilly, and other innovative life sciences organizations on key challenges impacting medical affairs and a roadmap for success in the coming decade. Sponsored by: SHYFT Analytics This whitepaper provides a snapshot of where the biopharma industry is now, where it's heading, and how companies are allocating their resources to adapt & grow. Sponsored by: IBM Watson Health IBM’s highlighted solutions reside in a security-rich cloud environment—home for capturing, managing and analyzing clinical study data with control, accuracy and confidence. These solutions lay the groundwork for further integration with IBM® Watson® cognitive technology. Sponsored by: IBM Watson Health Inpatient View and Outpatient View are powered by robust data assets and use sophisticated projection methodologies to help ensure accuracy of reporting. Sponsored by: IBM Watson Health Acknowledging various stakeholder networks, as well as recognizing variances within the regulatory environment, we believe, is essential for companies looking to uncover the right decision-makers in support of biologics or biosimilars. Learn more. Sponsored by: ON24 Discover solutions to the most common challenges faced by medical device companies. Sponsored by: Eli Lilly and Company in partnership with Xcenda Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system. Sponsored by: Article Galaxy powered by Reprints Desk This white paper examines the skyrocketing cost of drug development and provides step-by-step guidance for executing a successful fail fast strategy. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. FierceBiotech Executive Breakfast at the J.P. Morgan Healthcare Conference 2020 January 14, 2020 | The Fairmont Hotel | San Francisco, CA 4th Annual Gene Therapy for Rare Disorders March 30 – April 2, 2020 | Boston, MA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 