This week's sponsor is Premier Research. | | How Psoriasis Treatment Advanced, and What's Next Thanks to new biologics, more than half of treated psoriasis patients achieve essentially clear skin. Our white paper examines how we got here, and what's next. Premier Research. It's what we do. Best. | Today's Rundown Bluebird and Celgene’s CAR-T hits the mark in myeloma Phase 2 data for Roche’s lymphoma ADC doesn’t disappoint Syros tanks on single-digit response rate in AML, MDS trial [Sponsored] How Real World Evidence and Value-Based Contracts Can Help Payers and Manufacturers Find Common Ground in Rare Disease GlaxoSmithKline on the prowl for early-stage cancer deals to jump-start pipeline Gilead backs $60M Hookipa round to fund immunotherapy R&D Adding precision to multiple myeloma treatments with DNA sequencing: ASH FierceMedTech’s 2017 Fierce 15 Featured Story | Monday, December 11, 2017 Patients with highly advanced multiple myeloma have seen spectacular results with Bluebird Bio and Celgene’s CAR-T therapy bb2121; the disease was pushed into remission in more than half of those treated. |
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| This week's sponsor is FierceBiotech. | | | Top Stories Monday, December 11, 2017 With breakthrough designation from the FDA and priority medicine status in the EU, expectations for Roche’s antibody-drug conjugate for non-Hodgkin lymphoma polatuzumab vedotin are running pretty high. Phase 2 data presented at ASH 2017 suggests that optimism could be justified. Monday, December 11, 2017 Syros Pharmaceuticals has emerged from the weekend of ASH data drops in a battered state after it was unable to put a positive spin on an initial look at phase 2 data. The clinical trial recorded one partial or complete response among the 48 evaluable patients, wiping 50% off Syros’ stock. Monday, December 11, 2017 When payers and manufacturers brawl over pricing, patients with rare diseases can suffer. Is there any common ground? Both sides believe real-world evidence can help quantify the benefits of a medication, and value-based contracts can ensure patients reap the rewards. Monday, December 11, 2017 After unveiling an R&D makeover this summer, GlaxoSmithKline is looking to reassert itself in the oncology space. To that end, the drugmaker is seeking deals in cancer medicine and immunology, said pharma chief Luke Miels in an interview with Reuters. Monday, December 11, 2017 Gilead has joined Boehringer Ingelheim and Takeda on the list of investors in Hookipa Biotech. The Big Biotech participated in a $60 million (€50 million) series C intended to equip Hookipa to advance its cytomegalovirus vaccine and cancer candidate through early clinical testing. Monday, December 11, 2017 At the annual American Society of Hematology (ASH) meeting, oncologists at the Dana-Farber Cancer Institute demonstrated how simple blood tests may make it possible to use DNA sequencing to track how multiple myeloma is progressing in individual patients—and whether they're becoming resistant to the therapies they’re given. Monday, December 11, 2017 When we were compiling this year’s crop of Fierce 15 companies, some clear themes stood out. Genomics. Bioelectronics. Artificial intelligence. But while multiple companies are working to improve the use of these technologies, there runs a deeper current: making care more accessible. Resources Sponsored by: Seton Hall Don’t miss this educational program trusted by multi-national companies as part of their employee’s compliance training. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating in the Asia-Pacific region. Visit event page for session topics. Wednesday, November 1, 2017 SO CLOSE AND YET SO FAR. Is that how many documents seem to you? Getting what you want—when, where, and how you want it—can be a real pain. That’s why we created this concise guide to getting around the obstacles that stand between you and the information your organization needs. Download the whitepaper to learn more. Sponsored by: WCG Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals. 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. 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 |