| 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 | Thursday, May 11, 2017  After deals and acquisitions with Spark Therapeutics and Bamboo, Pfizer is once again looking to bolster its rare and gene therapy pipeline as it outlines a new drug pact with Sangamo.
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| This week's sponsor is Sensors Expo & Conference 2017. | |  | |
| Thursday, May 11, 2017 Astellas has halted a phase 3 trial of ASP8273 in non-small cell lung cancer (NSCLC) and scrapped plans to start other development programs targeting the indication. The decision follows a review of data generated to date by an independent data monitoring committee. |
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| Thursday, May 11, 2017 Japan’s Daiichi Sankyo has been wielding the ax over the past quarter to half a dozen pipeline medications across cancer, diabetes and CV disease. |
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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. | Thursday, May 11, 2017 The FDA has sent a warning letter to a trial site studying Ionis Pharmaceuticals’ IONIS-TTRrx. The letter relates to an investigator-sponsored trial, not Ionis’ phase 3 study, but the regulator’s criticism of the site’s compliance with platelet monitoring requirements has raised broader worries about the real-world viability of the antisense drug. |
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| Thursday, May 11, 2017 Activist investor Starboard Value is demonstrating its confidence in Parexel by disclosing a 5.7% stake buy in the company, immediately after news of the CRO’s potential $4 billion sale went out on the street. |
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| Thursday, May 11, 2017 Harvard professor Timothy Springer has always been interested in developing antibodies targeting proteins that are “extracellular”—meaning they reside in bodily fluids, outside of cell walls. But he found that funding was lacking. So he created the Institute for Protein Innovation, which launched in Boston today. He spoke to FierceBiotechResearch about the new institute. |
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| Wednesday, May 10, 2017 Intrinsic Therapeutics raised $28 million in equity and $21 million in debt for its implant that addresses challenges in spinal surgery to remove a herniated disc. |
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| Thursday, May 11, 2017 GlaxoSmithKline has dodged yet another bullet on the generic Advair front. Partners Hikma and Vectura revealed Thursday that the FDA had struck down their knockoff version of the respiratory blockbuster. And given “the nature of the feedback” from FDA officials, the companies now see approval this year as a long shot. |
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| 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. |
| | | Bayer and CRISPR Therapeutics' JV biotech, Casebia, has added a host of new execs, including Ellen Ridge as SVP of operations; Abraham Scaria as VP of ophthalmology; and from July, Andrew Scharenberg as its new CSO and VP of hematology. Release Rhythm has seen the FDA expand on its previously granted Breakthrough tag for setmelanotide, the company's novel melanocortin-4 receptor agonist. Statement Merus Labs International and Norgine have signed a deal that will see Norgine buy up all of the issued and outstanding common shares of Merus for $1.65 a share in cash, including its debts, for a total of $342 million. Release | |
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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. |
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