This week's sponsor is Roquette. | | Roquette - The Biological Choice Sole custody of our supply chain ensures a safe, secure and reliable supply of quality raw materials and excipients. Trust Roquette for all your biopharma needs. Learn more. | Note: FierceBiotech will not publish on Monday due to the Memorial Day holiday, but will be back in your inbox on Tuesday, May 30. Featured Story | Friday, May 26, 2017 Scott Gottlieb, M.D., has ended the hiring freeze President Donald Trump imposed on the FDA. The action means Gottlieb can fill vacancies to shape an agency capable of enacting his plans for how safety and efficacy information are gathered during development. |
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| This week's sponsor is Precision for Medicine. | | Case Study: Harmonizing biomarker data Managing biomarker data can produce an order-of-magnitude reduction in time and cost, mitigate major risks to your study and even prepare you to meet new FDA requirements. Download a free case study now. | Top Stories Friday, May 26, 2017 Missing a secondary endpoint in the RADIANCE trial won't hinder the launch or commercial success of ozanimod, CFO Peter Kellogg tells Barclays analysts. Friday, May 26, 2017 There is no cure for heart failure, but scientists at Nagoya University have identified a protein on the surface of heart cells that could be targeted to stop the condition from getting worse. Monday, May 22, 2017 With pressures to fast-track clinical development, the pharmaceutical industry recognizes the value of improving internal clinical data management processes. Learn how using comprehensive analytical capabilities helps to advance clinical trial execution. Friday, May 26, 2017 The medical device industry appears to be under siege by cybercriminals, but it isn't taking steps to defend itself, according to two separate reports. Thursday, May 25, 2017 In this week's EuroBiotech Report, Iterum raises $65 million for a phase 3 trial, J&J incubator gets a dedicated VC fund, Merck KGaA accepts an Ablynx asset and more. Friday, May 26, 2017 Merck's HPV shot Gardasil is set for a head-to-head competition with GSK's Cervarix in China, Lupin's Q4 sales in North America fell 13%, China’s CANbridge gained $25M series B to advance immunotherapies, and more. Thursday, May 25, 2017 Alexion experienced a major C-suite overhaul that included its CFO, CCO, R&D head and HR chief; Van Oene's title as Illumina's CCO was finalized; and INC Research unveiled its entire executive team after the megamerger with inVentiv Health. | Eye disease biotech Aerie Pharmaceuticals has priced its public offering of $75 million of its common stock at $53.75 per share. Release Immune Pharmaceuticals said it received a written notice from Nasdaq that it has now regained compliance with the minimum bid price rule. Statement The number of new drugs given the green light in the U.S. and Europe is booming in 2017 after a rough 2016. Reuters Health story | |
| Resources Sponsored by Envigo Performing a sophisticated surgery to create a myocardial infarction model. Join us on June 7th at 11:00 AM EDT. 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. Sponsored By: HealthCore Gain critical insights into how to design and implement pragmatic trials and generate relevant, high-level real-world evidence. Learn when to conduct PTs, design considerations, ethical regulatory issues — and more. Sponsored By: Veeva Join this global webinar to learn a new approach for demonstrating medical affairs' impact with better metrics - beyond reach and frequency, enabling launch success and better engagement with strategic KOL insights, and increasing your organization's share of voice in the healthcare landscape. Presented By: Covance The ICH GCP E6 guideline has been revised to address the complexities associated with today’s clinical trials, and this concise white paper will help you understand the recent guideline changes. Learn how use of risk-based monitoring can help you comply with the guidelines and achieve efficiency in clinical trial design, implementation and reporting. Sponsored By: Veeva To thrive in a fiercely competitive market, life sciences companies need to set themselves apart by designing and executing the best trial and successfully deliver drugs to market first. Learn how a modern EDC can help. Sponsored By Reprints Desk Puzzled by Scientific Literature Access? Here is your guide for navigating knowledge management’s twists and turns! If yours is a small- or medium-sized biopharma business, we can help you putting the pieces together. Learn the secrets of top knowledge management experts who will show you how to search, discover, acquire and manage knowledge in new ways. Presented By: Covance The recent evolution of immunotherapies and their potential applications have greatly impacted patients’ options for effective oncology treatments. These advances have been powered in part by the use of biomarkers, companion diagnostics (CDx) and complementary diagnostics. Read the white paper. Sponsored By: DocuSign DocuSign’s eSignature solutions modernize healthcare and life science organizations by eliminating paper and antiquated signature processes while meeting compliance requirements and reducing costs and errors. Sponsored By: DocuSign The patients who rely on your scientific leadership are expecting more. Sponsored By: DocuSign The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company. FierceBiotech Executive Breakfast- Tackling the Drug Price Problem: A Town Hall Debate June 21, 2017 | San Diego, CA MIXiii-BIOMED 2017 May 23-25, 2017 | Tel Aviv, Israel FierceBiotech 2nd Drug Development Forum September 25-27, 2017 | Boston, MA 2017 BIO International Convention: The Largest Global Biotech Partnering Event of the Year June 19-22 | San Diego, CA Life Sciences Event of the Year! DIA 2017 Global Annual Meeting Drug Development Boot Camp® 2017 November 15-16, 2017 | Boston, MA |