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 Sanofi hires ex-Roche executive John Reed to replace retiring Elias Zerhouni as R&D chief Restless R&D executives, and a few FDA staffers, on the move to rival pharmas Adcomm backs lower dose of Lilly, Incyte's baricitinib but not higher [Sponsored] Can the SEC step in to support small businesses if Congress stalls? FDA slaps partial hold on Epizyme’s lead drug; analysts say ‘don’t panic’ Eli Lilly unveils galcanezumab migraine analysis as FDA decisions near Alnylam builds out case for patisiran, showing sharp drop in hospitalization, mortality Revolution Medicines tees up for oncology IND with $56M series B Shire-hunting Takeda notches R&D collaboration with Nektar, pair to combo I-O drugs Cedilla Therapeutics launches with $56M to target protein degradation in cancer Urovant poaches Allergan's key urology executive Cornelia Haag-Molkenteller Featured Story | Tuesday, April 24, 2018 Sanofi is changing its head of global R&D. Elias Zerhouni, M.D., is to retire from the position at the end of June, leaving former Roche research leader John Reed, M.D., Ph.D., to take charge of Sanofi’s pipeline. |
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| This week's sponsor is Deloitte. | | | Top Stories Tuesday, April 24, 2018 The last few weeks have seen major R&D moves from big pharma companies including Sanofi, AstraZeneca, Roche, Gilead, Novartis, Amgen and GlaxoSmithKline. Monday, April 23, 2018 The expert panel voted 10-5 in favor of the 2-mg dose but flipped those numbers to vote 10-5 against the 4-mg dose. Monday, April 23, 2018 Congress is debating whether to include small businesses in the Senate’s bank bill. But the SEC has an opportunity to take action on SOX 404(b) on its own. Tuesday, April 24, 2018 Shares in Epizyme slipped in premarket trading today after the company announced a suspension of patient recruitment in a trial of its lead cancer drug after a patient developed a secondary lymphoma, but analysts at Jefferies are expecting the stock to bounce back. Tuesday, April 24, 2018 Eli Lilly presented a post hoc analysis of its monthly migraine therapy galcanezumab, one of a new class of targeted preventive drugs, as it looks to show the drug's effectiveness after the failure of other treatments. Tuesday, April 24, 2018 Alnylam has presented a fresh take on its phase 3 patisiran data as it builds out its case ahead of an anticipated landmark approval. The new angle comes from an exploratory post hoc analysis which linked the RNAi therapy to a 50% drop in all-cause hospitalization and mortality over placebo. Tuesday, April 24, 2018 The capital will push Revolution's lead program, a SHP2 inhibitor, into the clinic. Since its launch in 2014, the Bay Area biotech has narrowed its focus to "frontier targets," or targets that have previously been considered undruggable. Tuesday, April 24, 2018 Takeda, with apparently near infinitely deep pockets for M&A and collaborations, has struck a deal: not to buy Shire, as yet, but rather with Nektar, as the two eye new trials of their respective immuno-oncology assets. Tuesday, April 24, 2018 Cedilla is targeting processes that transition cancer-driving proteins from a stable state to a state susceptible to degradation. Tuesday, April 24, 2018 Urovant Sciences is bringing on Allergan’s Cornelia Haag-Molkenteller as its chief medical officer and establishing a new U.S. headquarters in California. The move comes shortly after launching a phase 3 trial for vibegron, its sole drug candidate, in overactive bladder. This week's sponsor is PharmaCord. | | | 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: Seton Hall Law 4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics. 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: 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! |