This week's sponsor is Premier Research. | | Discovering the Great Potential of Immuno-Oncology Drugs Immuno-modulating agents have been around a long time, but for limited uses. New immuno-oncology pathways promise big advances against a wider range of cancers. Register now for our May 23 webinar. Premier Research. It's what we do. Best. | Featured Story Wednesday, May 10, 2017 A phase 3 trial of AstraZeneca’s tralokinumab in patients with severe, uncontrolled asthma has missed its primary endpoint. The anti-interleukin-13 human monoclonal antibody failed to cut the annual asthma exacerbation rate by more than placebo, forcing AstraZeneca to hitch its hopes for the drug to the planned analysis of a subpopulation of patients. |
|
| This week's sponsor is Sensors Expo & Conference 2017. | | | Top Stories Wednesday, May 10, 2017 Quintiles and IMS Health came together last year in a massive $19 billion megamerger, and now INC and inVentiv are looking to follow suit, combining into one new major company that will according to the pair make it the second largest biopharmaceutical outsourcing provider in the world. |
|
| Wednesday, May 10, 2017 Sage Therapeutics posted phase 2 results from its Parkinson’s disease study yesterday in which it said its experimental med could help tremors, but the top-line data were met with confusion by Bio Twitter, and its shares fell more than 3% in normal hours trading. |
|
| Monday, May 8, 2017 Biosimilars development in the U.S. is still rapidly growing and shifting. We discuss the key issues sponsors face today – from nonclinical testing to commercialization – along with considerations for a strategic regulatory approach. Wednesday, May 10, 2017 As expected, Scott Gottlieb, M.D., has been confirmed as the new head of the FDA, about four months after his Obama-picked predecessor Robert Califf stepped down. |
|
| Wednesday, May 10, 2017 Oxford Genetics has licensed CRISPR gene editing technology from ERS Genomics. The agreement gives the British synthetic biology service provider the right to use CRISPR technology to improve gene therapy viral vectors and develop cell lines. |
|
| Wednesday, May 10, 2017 Boston Scientific has received FDA approval for its Resonate line of high-voltage cardiac devices. The regulatory nod clears Boston Scientific to start selling devices it thinks can overcome reticence among physicians to use multipoint pacing products by diminishing concerns about battery life. |
|
| Tuesday, May 9, 2017 AstraZeneca’s Imfinzi won its bladder cancer approval just last week—but it’s no longer the newest immuno-oncology med for the condition. |
|
| This week's sponsor is MedNet Solutions. | | WHITE PAPER: Data Safety Monitoring Boards & eClinical This FREE White Paper explores Data Safety Monitoring Boards & Data Monitoring Committees, their role in managing patient risk, and how eClinical systems simplify their work. DOWNLOAD. | | AbbVie has posted what it calls "promising results" from its CELEST phase 2 study for its JAK1 inhibitor upadacitinib (ABT-494) in Crohn's disease. Release Fragile X syndrome-focused biotech Fulcrum Therapeutics has secured additional Series A funding from Alphabet’s Google Ventures. Statement NantHealth has promoted former Caris Life Sciences executive Sandeep Reddy, M.D., to chief medical officer. Release | |
| Resources 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. 8th Transparency and Aggregate Spend West May 23-24, 2017 | San Diego, CA Drug Development Boot Camp® 2017 November 15-16, 2017 | Boston, MA Life Sciences Event of the Year! DIA 2017 Global Annual Meeting Medical Sensors Design Conference May 8-9, 2017 │ Boston Marriott Newton │ Newton, MA Rational Combinations 360° in Immuno-Oncology June 28-29, 2017 | New York, NY MIXiii-BIOMED 2017 May 23-25, 2017 | Tel Aviv, Israel FierceBiotech Executive Breakfast- Tackling the Drug Price Problem: A Town Hall Debate June 21, 2017 | San Diego, CA 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 |