This week's sponsor is TD2. | | 6 Signs You Need a New CRO for Your Preclinical Research Are your preclinical studies where they deserve to be? If progress has stalled, maybe it's your CRO that's the problem...not you. Learn these six telltale signs it's time to switch. Fast-Track Your Research with TD2. | Today's Rundown Selecta slumps as interim gout data gets frosty reception vTv's azeliragon fails to improve Alzheimer's symptoms in phase 3 Frazier Healthcare Partners closes $780M growth buyout fund Novartis offloads failed cancer drug to Oncology Venture Promethera buys TNF drug to boost cell therapy NASH strategy FDA moves the goal line on AbbVie's endometriosis drug elagolix Ayala notches up $17M in financing to push BMS drug into phase 2 FDA directive restricts sale of Bayer's Essure device Featured Story | Tuesday, April 10, 2018 Selecta Biosciences has posted three-month data on SEL-212 in chronic severe gout. The biotech painted data from the ongoing phase 2 trial as positive for the prospects of SEL-212, but the outside world took a different view, sending Selecta’s stock down by more than 20% premarket. |
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| This week's sponsor is Deloitte. | | | Top Stories Monday, April 9, 2018 Another day, another Alzheimer's treatment bites the dust. This time, it's vTv Therapeutics' azeliragon, which missed both of its co-primary endpoints in a phase 3 trial of patients with mild Alzheimer's. Tuesday, April 10, 2018 Investment firm Frazier Healthcare Partners has closed its 11th fund—worth $780 million—that will be used to help established companies accelerate their growth. Tuesday, April 10, 2018 Oncology Venture has licensed a once-failed cancer drug from Novartis. The Swedish biotech picked up small molecule multi-kinase inhibitor dovitinib after an analysis of historic trial data suggested its drug response predictor will increase the likelihood of success. Tuesday, April 10, 2018 Promethera Biosciences has stepped up its NASH plans with the takeover of Baliopharm. The buyout gives Promethera control of a TNF receptor 1 inhibitor it hopes will amplify the effects of cell therapy HepaStem. Tuesday, April 10, 2018 The FDA is pushing back the PDUFA date for AbbVie and Neurocrine's drug for endometriosis-linked pain to Q3, saying it needs more time to review the results of liver function tests. Tuesday, April 10, 2018 Israeli biotech Ayala Pharmaceuticals, founded last year as a development vehicle for two of Bristol-Myers Squibb’s cancer candidates, has raised $17 million in a series A financing. The cancer startup says its lead candidate will start a phase 2 trial in rare cancer adenoid cystic carcinoma later this year. Monday, April 9, 2018 The FDA is using a "unique type of restriction" to make sure only providers and facilities that inform patients about the risks and benefits of Bayer's Essure birth control device may offer it. This week's sponsor is Sensors Expo. | | | Enrollment Showcase | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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| Resources Sponsored by: Veeva Systems Explore a new model for events management, and learn how to deliver more value. Sponsored by: WCG Small biopharma companies are conducting almost 50% of the clinical trials in the US today, yet they face unique challenges that large pharma do not. In this paper, we explore some of those challenges, and solutions that can reduce the pressure on small biopharma teams and timelines. Sponsored by: Halo Pharma Why does confidence matter when outsourcing Fixed-Dose Combination products? Download Halo Pharma’s white paper on the importance of product design, technology, and analyticals tools for FDC. Sponsored by: USDM Life Sciences What are the biggest trends in life sciences this year? Presented by: Patheon, part of Thermo Fisher Scientific Patheon's Stephen Lam reviews the formidable challenges and decisions facing biopharma manufacturing executives. Watch as he shares unique insights and perspectives and demonstrates how there is really no one-size-fits-all solution in biomanufacturing, regardless of company size. Presented by: Charles River How do you get your oncology therapy to the clinic? The path isn’t always clear. In vitro, ex vivo, xenograft, syngeneic, PDX, humanized models, immunology considerations, safety regulations – which do you need to plan for and when? Sponsored by: DocuSign Life science companies are experiencing a significant transformation in how they bring new products to market. Sponsored by: Reprints Desk The competitive landscape in medical device R&D is tough. And simply investing in R&D is no guarantee for profitability. So how do you accelerate time-to-market? Sponsored by: WCG Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals. Presented by: Covance Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives. Presented by: Charles River Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols. Presented by: Catalent Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility. Presented by: Catalent Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology. Presented by: Catalent Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing. Sponsored by: RTI Health Solutions In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA IRT Europe – Interactive Response Technologies in Clinical Trials April 10th-11th, 2018 | Brussels, Belgium Field Service USA 2018 April 17-April 20, 2018 | JW Marriott Palm Desert Resort & Spa, CA
Drug Development Immersion April 25-26, 2018 | New York City Biotech for the Non-Scientist May 2-3, 2018 | San Diego, 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 Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! |