| This week's sponsor is Premier Research. | | | 6 Considerations When Designing Hematology Clinical Trials
Researchers are turning a corner in treating and curing blood disorders. Download our paper for 6 dosing and safety considerations for developing early-phase trials. Premier Research. It's what we do. Best. |
Today's Rundown J&J snaps up Idorsia’s resistant hypertension candidate, paying $230M Mystery U.S. fund plans $1B U.K. investment: Financial Times Loxo, Bayer maintain 90%-plus response rate in cancer trial OrbiMed, Peter Thiel back NASH mAb biotech Pharma-backed Outpost nabs Mitsubishi, Pfizer exec Ian Mills Ultragenyx up on XLH drug's phase 3 success Could BMS’ immuno-oncology hit Opdivo also attack HIV? Featured Story | | | Monday, December 4, 2017 Swiss biotech Idorsia spun out of Actelion before it was taken over by Johnson & Johnson earlier this year, but the big pharma has confirmed it will still play a big part in one of its lead products. |
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| This week's sponsor is Precision Oncology. | | | What's hot at ASH? Accelerated approvals. Get the POV.
New cancer therapies are getting approved in less time, with fewer patients. How is this possible? Download our free Pre-ASH POV to find out and visit Precision Oncology at ASH Booth 2540. |
Top Stories Monday, December 4, 2017 A U.S. life sciences fund is set to invest up to $1 billion (€840 million) in the United Kingdom biotech sector, the Financial Times reports. The as-yet-unidentified fund will reportedly embark on the spending spree while shifting a “significant” chunk of its operations from the U.S. to the U.K. Monday, December 4, 2017 Bayer has shared results showing why it was willing to spend big on Loxo Oncology’s larotrectinib. The latest data drop shows 94% of children with advanced solid or primary CNS tumors remain on the oral TRK inhibitor. Monday, December 4, 2017 PayPal founder Peter Thiel and VC OrbiMed’s Israel unit have helped ChemomAb raise $10 million in a series B round. Monday, December 4, 2017 The pharma-biotech executive jumps show no sign of abating as a former Pfizer vet joins the ranks of startup Outpost Medicine as its R&D trials lead. Monday, December 4, 2017 Ultragenyx Pharmaceuticals chalked up another win for its rare bone disease drug, burosumab, keeping it on track for a U.S. regulatory filing. Friday, December 1, 2017 When doctors in Paris treated an HIV-infected lung cancer patient with Bristol Myers-Squibb’s immuno-oncology drug Opdivo (nivolumab), they were stunned to discover a huge decrease in the patient’s viral “reservoirs”—hideaways in the body that allow HIV to escape from antiretroviral treatments. Resources Sponsored by: Deloitte Sourcing research externally seems to be the preferred path for biopharma companies to strengthen their R&D pipeline. Sponsored by: Veeva Systems Read this guide if you’re a global life sciences company - conducting clinical trials across several countries, or manufacturing and distributing products in multiple regions - to learn five steps to align and improve quality oversight, as well as avoid common mistakes in harmonization initiatives. Sponsored by: Veeva Systems Read Deloitte Consulting's whitepaper on the value of a holistic RIM capability, covering the potential cost savings and revenue gains from doing RIM right. Presented By: Covance Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives. Sponsored by: Veeva Systems See the results from one of the largest, most in-depth surveys of clinical data management professionals on data management practices, performance, and challenges. Sponsored by: Veeva Systems Gain a complete, real-time view of quality and streamline operations. Incorporate partners into processes for critical oversight and 30% greater efficiency, and transform cross-functional processes like change control. Presented by: DSM Biomedical Discover DSM's Dyneema Purity® membrane, an effective and efficient material to construct stent grafts used in minimally invasive surgeries to treat both cardiovascular and peripheral arterial diseases. Sponsored by: ePharmaSolutions As clinical trials become more complex, safety document distribution to investigative sites has reached the point that demands a solution. Sponsored by: Ashfield Healthcare December 5, 2017 | 2pm EST / 11am PST Join this webinar to learn methods that maintain and build sales momentum despite turnover. Presented By: Charles River Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols. Presented By: Catalent Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility. Presented By: Catalent Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology. Presented By: Catalent Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing. 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. FierceBiotech Executive Breakfast: Get Good Science and the Money will Follow January 9, 2018 | San Francisco, CA BIO CEO & Investor Conference February 12-13, 2018 | New York, New York | 