This week's sponsor is Premier Research. | | Opportunity Knocks: Seizing the Promise of Orphan Drugs Orphan drug developers enjoy more favorable regulatory conditions today than ever. Read our white paper for tips on maximizing this opportunity. Premier Research. It's what we do. Best. | Today's Rundown BMS' Opdivo-Yervoy combo posts big win in first-line lung cancer—but big enough to challenge Merck? Phase 1 data backs Cyclacel’s plans for CDK2/9 inhibitor Flagship’s Evelo files for $100M IPO as human testing of monoclonal microbials nears [Sponsored] It Might Be a Bumpy Ride: Why Life Sciences Companies Should Consider Embracing the New Wave of Change In a monster showing, Merck's Keytruda combo slashes lung cancer death risk by half Blueprint reports promising phase 1 data in RET-altered tumors: AACR Apitope preps Graves’ disease drug for phase 2 after positive trial Lysogene delays Sanfilippo gene therapy phase 3 Featured Story | Monday, April 16, 2018 Back in February, Bristol-Myers Squibb tallied a win for its immuno-oncology combo in first-line lung cancer. But one question still remained: Was the win big enough to keep it competitive against rivals? |
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| This week's sponsor is Trianni. | | | Top Stories Monday, April 16, 2018 Just over a year ago, Cyclacel was hit by a late-stage failure in leukemia that sent its shares into a tailspin and pushed an early-stage CDK inhibitor into the spotlight as its most promising candidate. Now, that CDK drug has shown it can stabilize disease in advanced cancers and is ready to be twinned with AbbVie's leukemia drug Venclexta in phase 2. Monday, April 16, 2018 Evelo Biosciences has filed for a $100 million initial public offering. The pitch to public investors comes as the Flagship Ventures’ startup prepares to test its lead inflammatory disease and anticancer microbial strains in humans. Monday, April 16, 2018 Changes in technology and geopolitics, coupled with U.S. tax reform and new financial accounting standards, are creating disruption in accounting and financial reporting for life sciences companies. Monday, April 16, 2018 Merck's Keytruda-chemo combo is already approved in first-line lung cancer based on phase 2 data, but that FDA nod requires backup from a larger phase 3 trial—and doctors and investors have worried the data wouldn't measure up. They don't have to worry anymore. Monday, April 16, 2018 Blueprint Medicines presented proof-of-concept data showing its BLU-667 shrank tumors in 84% of patients with lung or thyroid cancer. Monday, April 16, 2018 Apitope has taken a step closer to developing the first new treatment option for thyroid disorder Graves’ disease in decades after posting positive results in a first-in-human trial of its ATX-GD-59 antibody. Monday, April 16, 2018 A manufacturing delay has pushed back the start of Lysogene’s pivotal Sanfilippo syndrome trial. The gene therapy study is now due to get underway in the second half of the year. This week's sponsor is Thermo Fisher. | | | 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 Learn how leading companies, from the world’s top pharma to emerging biotechs, are empowering their medical affairs teams. 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 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 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 18th International Biotechnology Symposium and Exhibition August 12-17, 2018 | Montreal, Canada Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! |