Today's Rundown Sarepta CEO dispels FDA 'bias' theory, but no update on when CRL will be resolved AnaptysBio's IL-33 antibody stumbles in midphase eczema trial Monopar Therapeutics puts the brakes on IPO, again [Sponsored] Flip the Funnel: Rethinking Patient Recruitment and Enrollment Strategies FTC orders artificial limb maker Ottobock to undo and divest its knee acquisition EuroBiotech Report—AstraZeneca in China, Novo's pipeline, Vifor and Ipsen FiercePharmaAsia—Amgen-BeiGene $2.7B tie-up; AZ's China projects; controversial Alzheimer's drug Chutes & Ladders—Teva names replacement for outgoing CFO McClellan Featured Story | | | Friday, November 8, 2019 Sarepta Therapeutics' chief Doug Ingram has come out against accusations that the FDA is biased against the company after its recent drug rejection but offered no timing on when the agency's concerns will be fixed. |
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Top Stories Friday, November 8, 2019 After clearing a midstage study in asthma last fall, AnaptysBio’s anti-IL-33 antibody missed the mark in a phase 2b trial testing it in atopic dermatitis, or eczema. The drug, etokimab, did worse than placebo at easing symptoms such as itch and skin inflammation after 16 weeks of treatment. Friday, November 8, 2019 It's déjà vu for cancer biotech Monopar Therapeutics as the company delays getting off its initial public offering for the second time. Monday, November 4, 2019 No matter how successful advertising campaigns are, all that really matters is how many referrals ultimately participate in the trial. It’s time to flip the funnel and focus on converting recruits into enrollees. Thursday, November 7, 2019 After two years, the Federal Trade Commission has ordered the German prosthetics company Ottobock to roll back its acquisition of Freedom Innovations, saying the merger of the two manufacturers would weaken competition in the market for computer-controlled prosthetic knees. Thursday, November 7, 2019 In this week's EuroBiotech Report, AstraZeneca steps up committment to China, Novo adjusts pipeline and Vifor allies with Evotec. Friday, November 8, 2019 Amgen is taking a 20.5% stake in BeiGene, which will help the Big Biotech develop cancer drugs in China. AstraZeneca, along with several Big Pharma companies, tightens its ties to China. A newly approved Alzheimer's drug from a Chinese firm raises questions. And more. Friday, November 8, 2019 Teva picks Flex's Kalif to replace CFO McClellan; Endo head Campanelli heads out; Hahn gets pick to be FDA chief. Enrollment Showcase Resources Sponsored by: Veeva Systems Medical Affairs 2025 brings together leading perspectives from AstraZeneca, Bristol-Myers Squibb, Merck, Lilly, and other innovative life sciences organizations on key challenges impacting medical affairs and a roadmap for success in the coming decade. Sponsored by: SHYFT Analytics This whitepaper provides a snapshot of where the biopharma industry is now, where it's heading, and how companies are allocating their resources to adapt & grow. Sponsored by: IBM Watson Health Acknowledging various stakeholder networks, as well as recognizing variances within the regulatory environment, we believe, is essential for companies looking to uncover the right decision-makers in support of biologics or biosimilars. Learn more. Sponsored by: ON24 Discover solutions to the most common challenges faced by medical device companies. Sponsored by: Eli Lilly and Company in partnership with Xcenda Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system. Sponsored by: Clarivate Analytics 18 high-value new licensing deals worth in excess of $500 million took place during the second quarter of 2019 -Get the Q2 2019 Biopharma licensing report for full details and insights. Sponsored by: Patheon, by Thermo Fisher Scientific Is your API development on track? Sponsored by: BBK Worldwide Get the latest data on how people are using apps to manage their health, and learn how you can leverage it in the development of your next clinical trial app. Sponsored by: Blue Latitude Health Report: How to design digital services that deliver value and improve outcomes for patients, healthcare professionals and the healthcare systems they serve Sponsored by: Article Galaxy powered by Reprints Desk This white paper examines the skyrocketing cost of drug development and provides step-by-step guidance for executing a successful fail fast strategy. Sponsored by: Outer Edge Technology Companies that don’t have a cloud strategy are at a competitive disadvantage. Why? The cloud has a measurable impact on business. Sponsored by: Colorcon® Learn about how you better manage product authentication and battle drug counterfeiting with innovative solutions. Sponsored by: Roche and IQVIA A global landscape study of funding trends and innovations. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. Advanced Therapies: Immunotherapies, Cell Therapies and Gene Therapies November 15, 2019 | Boston, MA A Rare Affair for Rare Diseases January 12, 2020 | San Francisco, CA | 