| 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 Checkmate's I-O combo reverses PD-1 resistance in melanoma patients Johnson & Johnson scraps phase 3 antibiotic program acquired in $30B Actelion takeover Plot twist: FDA pivots on Alkermes' depression drug [Sponsored] It Might Be a Bumpy Ride: Why Life Sciences Companies Should Consider Embracing the New Wave of Change Johnson & Johnson says it has 15% more to splash on R&D thanks to tax cuts. Will we see more pipeline plays? Johnson & Johnson buys into Bristol-Myers cardiovascular disease program Basilea slots ArQule FGF drug into its cancer portfolio Advent, near deal to buy Sanofi's Zentiva, lays out big goals for generics business Featured Story | | | Tuesday, April 17, 2018 A combination of Checkmate's toll-like receptor 9 agonist and Merck's Keytruda reversed PD-1 resistance in advanced melanoma patients who had not responded to previous anti-PD-1 treatments. |
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| This week's sponsor is Trianni. | | | |
Top Stories Tuesday, April 17, 2018 Johnson & Johnson has halted development of cadazolid in clostridium difficile-associated diarrhea. The antibiotic was one of two experimental assets J&J acquired in its $30 billion takeover of Actelion last year. Monday, April 16, 2018 Just two weeks after the FDA said it wouldn't even review Alkermes' depression drug because of “insufficient evidence of overall effectiveness," the agency has rescinded its refuse-to-file letter and accepted the application. 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. Tuesday, April 17, 2018 Share buybacks have been the name of the game for a few years now as M&A went through a quiet patch, but with deals ramping up in 2018, Johnson & Johnson says it's boosting its R&D budget over the coming years. Will the Big Pharma be looking to beef up its pipeline? Tuesday, April 17, 2018 Johnson & Johnson has bought into Bristol-Myers Squibb’s Factor XIa inhibitor program. The deal gives J&J a stake in the development and potential commercialization of anticoagulants including phase 2-ready secondary stroke candidate BMS-986177. Tuesday, April 17, 2018 Deal-hungry Basilea has extended its cancer pipeline by licensing ArQule’s derazantinib, a phase 2-ready drug that slots in ahead of its in-house oncology programs. Tuesday, April 17, 2018 The sources were right: Only one day after numerous media reports stated Sanofi was nearing a deal to sell its European generics business to Advent International, the pair admitted they're in exclusive negotiations. And they said Advent plans to transform Zentiva into a "generics leader." | 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! | 