| This week's sponsor is Premier Research. | | | Clearing the Path for Orphan Drug Development
The unmet therapeutic need in rare disease is huge, but so are the cost and complexity of drug development. Read our white paper to see how the FDA and EMA are easing the path to regulatory approval. Premier Research. It's what we do. Best. |
Top Stories Monday, December 5, 2016 UniQure has posted fresh data from a phase 1/2 trial of its hemophilia B gene therapy. The 12-month low-dose data and six-month high-dose results link AMT-060 to the near cessation of spontaneous bleeding and a sharp drop in Factor IX (FIX) replacement therapy, but the gene therapy continues to be dogged by comparisons to Spark Therapeutics’ rival program. Monday, December 5, 2016 British biotech ReNeuron has posted generally encouraging midstage data which showed their stem cell therapy could help certain stroke patients move their arms better after being left disabled by their condition. Despite not hitting its primary endpoint, it is still plotting a pivotal test starting next year. Monday, December 5, 2016 After passing on an option to buy Acetylon in the summer, Celgene has come back with a deal for a slimmed-down version of the biotech. Monday, December 5, 2016 Agios Pharmaceuticals has moved closer to starting a pivotal clinical trial of one of its wholly owned treatments for pyruvate kinase (PK) deficiency. The latest data drop tees Agios up to discuss a pivotal trial with regulators before deciding which of its two candidates to advance into a late-phase study in the indication. Monday, December 5, 2016 Teleflex has inked a deal to acquire Vascular Solutions for $1 billion, picking up devices for minimally invasive coronary and peripheral vascular procedures and gaining entry into those markets. Monday, December 5, 2016 At the ASH meeting in San Diego, Kite Pharma and Novartis presented impressive data on their chimeric antigen receptor T-cell (CAR-T) therapies to treat blood cancers, and both appear to be on track to file for FDA approval soon. But concerns about toxic side effects continue to dog this emerging form of immunotherapy. Now a set of researchers at the Fred Hutchinson Cancer Research Center in Seattle who are partially funded by Juno are investigating methods for fine-tuning CAR-T treatments—and they presented early signs of success. | | | Merck will do clinical work on Aduro Biotech's anti-CD27 antibody that has shown preclinical activity in helping create an anticancer immune response. Release Spark has signed an initial $30 million licensing deal to use Selecta Biosciences' tech with its gene therapies. Statement Purdue Pharma and AnaBios are joining forces to push on with R&D work for nonopioid, non-NSAID treatments in chronic pain. Release | |
|
Resources Presented By: Lenovo Get the stats you need to start down the path to a more secure infrastructure, today. Presented By: Lenovo What's the first step to a better patient experience? The patient experience starts well before the exam room or even reception - it begins as soon as your patients pull into the parking structure. Presented 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. Presented by: DocuSign The patients who rely on your scientific leadership are expecting more. Presented 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. Sponsored By: Salesforce Life sciences companies, like many industries today, face new challenges across the board. Read More. Presented By: ISR Reports Make essential outsourced bioprocessing decisions by staying informed of industry outsourcing practices and contract manufacturer usage patterns with ISR’s Bioprocessing Services and Technologies Market Trends and Outsourcing Dynamics report. Presented By: ISR Reports ISR’s Biosimilars in the US Oncology Market (2nd Edition) report provides data and insights from 101 US-based, board-certified oncologists/hematologist oncologists as to their expectations, fears, and aspirations for biosimilars in oncology. Presented By: ISR Reports Pinpoint the information oncologists find most valuable and the best sales channels for delivering specific types of data/information. Presented By: ISR Reports ISR’s Bioprocessing Market Trends and Outsourcing Dynamics: 2016-2021 report provides an overview of the current market dynamics for bioprocessing as well as an outlook on what the marketplace will look like in five years. Presented By: ISR Reports ISR’s CRO Quality Benchmarking – Phase II/III Service Providers (8th Edition) report provides a Consumer Reports-style analysis of Phase II/III CRO service quality from hundreds of users who rated 44 Phase II/III CROs across 26 critical dimensions of quality. Presented by: Patheon Can you avoid a risky trial-and-error approach to find the right path for your poorly soluble molecule by utilizing a CDMO? Download this complimentary Whitepaper to learn more! Presented by: Biotech Primer This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. Sponsored by: Veeva Systems Gartner research on short- and long-term strategies for IDMP compliance. FierceBiotech Executive Breakfast: Deciphering Immuno-Oncology, Trends in Deal-Making and R&D January 10, 2017 | San Francisco, CA Precision LBx Summit: Translating Next Generation Liquid Biopsies into Clinical Reality January 30-February 1, 2017 | San Diego, CA 24th International Molecular Medicine Tri-Conference February 19-24, 2017 | Moscone North Convention Center | San Francisco, CA DeviceTalks December 12, 2016 | Newport Beach, CA CBI’s IISR 2017 Summit February 14-15, 2017 | Philadelphia, PA | 