| 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 Biogen pays Ionis $1B to form discovery-stage pact After questioning Lilly/Incyte's baricitinib, FDA director jumps ship to AstraZeneca FDA ‘conflicted’ on Lilly and Incyte’s refiled baricitinib [Sponsored] It Might Be a Bumpy Ride: Why Life Sciences Companies Should Consider Embracing the New Wave of Change In a unanimous vote, FDA advisory committee waves through GW Pharma's cannabinoid Epidiolex MorphoSys supersizes IPO, bagging $208M for cancer R&D UCB offers $370M for Proximagen’s epilepsy spray, with NDA to follow Grail to seek an additional $1B in funding before Hong Kong IPO, report says EuroBiotech Report—Novartis names CMO, Inventiva, Lysogene delay and Basilea deal FiercePharmaAsia—Tussle for Shire, Hanmi’s EGFR bail, Grail’s $1B pre-IPO round Chutes & Ladders—GlaxoSmithKline poaches Roche executive for pipeline deal-making Featured Story | | | Friday, April 20, 2018 Biogen is paying $1 billion to enter into a discovery-stage R&D pact with Ionis Pharmaceuticals. The deal gives Biogen a chance to pick up a series of neurological antisense drugs identified by Ionis. |
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| This week's sponsor is Trianni. | | | |
Top Stories Thursday, April 19, 2018 The FDA’s Badrul Chowdhury is moving to AstraZeneca in the same week that he made a series of critical marks against Eli Lilly and Incyte's long-delayed baricitinib, which is set for an advisory committee on Monday. Friday, April 20, 2018 Eli Lilly and Incyte’s second attempt to get U.S. approval of rheumatoid arthritis drug baricitinib could be scuppered again by lingering FDA concerns about safety. 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. Thursday, April 19, 2018 An FDA advisory committee voted 13-0 in favor of GW Pharma's cannabis-derived epilepsy treatment, saying the drug's negative effects on the liver could be managed through labeling and education. Friday, April 20, 2018 MorphoSys has supersized its IPO, pulling in $208 million to develop its anti-CD19 antibody MOR208. The dialed-up IPO haul gives MorphoSys a $500 million-plus war chest to crash the CAR-T party with a drug it thinks provides safer, more durable efficacy without the cost or complexity of cell therapies. Friday, April 20, 2018 UCB plans to bolster its epilepsy portfolio by acquiring a nasal spray developed by Proximagen, agreeing to pay $150 million up front, with biobucks of $220 million also in the cards. Thursday, April 19, 2018 Cancer blood test developer Grail is reportedly considering whether to squeeze in yet another billion-dollar funding round before it goes public in Hong Kong later this year, according to Bloomberg. Thursday, April 19, 2018 In this week's EuroBiotech Report, Novartis nabs Amgen's CMO, Inventiva gears up for NASH phase 3, Lysogene delays trial start and more. Friday, April 20, 2018 Allergan was in and out of pursuit for Shire as Takeda's third offer was rejected, Hanmi ditched its would-be Tagrisso rival olmutinib, Grail is reportedly considering a $1 billion financing before its expected Hong Kong IPO, and more. Friday, April 20, 2018 GlaxoSmithKline steals Genentech oncology BD head Kevin Sin to lead R&D deal-making, Sanofi CFO Jérôme Contamine will retire, Amgen's John Tsai jumps to Novartis as CMO, FDA CDER director Badrul Chowdhury joins exodus to AstraZeneca, plus more hirings, firings and retirings throughout the industry. | 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 to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems. 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 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 Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA 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! | 