| 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 GlaxoSmithKline boss rethinking R&D incentives, as Barron and Sin seek out early and late-stage opportunities Mereo pulls IPO, blaming ‘challenging’ stock market conditions Twice rejected by Lilly, Adocia mounts recovery with diabetes drug deal [Sponsored] Can the SEC step in to support small businesses if Congress stalls? Saniona cleared for second phase of Prader-Willi syndrome trial Alder builds case for CGRP migraine drug eptinezumab Johnson & Johnson appeal of $151M hip implant ruling succeeds after judge finds talk of Iraqi bribes tainted case Featured Story | | | Wednesday, April 25, 2018 GlaxoSmithKline CEO Emma Walmsley has been in the hot seat for around a year, and while announcing the company's first-quarter results this week had new CSO Hal Barron by her side, as the two hinted at possible changes in R&D incentives and what another new hire made last week could bring to the pipeline. |
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| This week's sponsor is Deloitte. | | | |
Top Stories Thursday, April 26, 2018 Mereo BioPharma has withdrawn plans to list its stock on Nasdaq. The Novartis-backed biotech set out to bag $80 million (€66 million) to take its brittle bone disease drug into phase 3, only to struggle to raise the money on its desired terms. Thursday, April 26, 2018 Adocia has sold the Chinese rights to two diabetes prospects to Tonghua Dongbao Pharmaceuticals for $50 million (€41 million) upfront. The deal sparked a 30% jump in Adocia’s stock price as investors cheered evidence the biotech is gaining momentum 15 months after being dumped by Eli Lilly. 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. Thursday, April 26, 2018 Saniona has gotten the go-ahead it needs to continue a midstage trial of its combination therapy for Prader-Willi syndrome, a debilitating genetic disorder that causes insatiable appetite and obesity. Thursday, April 26, 2018 Alder BioPharma says data showing its intravenous drug eptinezumab can extend pain-free days between migraines will make it an important option for migraine prevention. Thursday, April 26, 2018 An appeals court has overturned a verdict that ordered Johnson & Johnson to pay $151 million to five people who received its Pinnacle hip implant. The appellate court overruled the prior verdict on the grounds the plaintiffs’ lawyer introduced “inflammatory character evidence” linking J&J to bribes allegedly paid in Saddam Hussein’s Iraq. | 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 Biotech for the Non-Scientist May 2-3, 2018 | San Diego, CA Translational Biomarkers: Advancing Neuroscience Drug Discovery and Development May 14, 2018 | South San Francisco, 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! | 