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Today's Rundown AbbVie’s JAK1 upadacitinib hits arthritis, but death registered in test Flagship Pioneering gains $618M for life science investment push Orchard raises $110M to bring gene therapy to market [Sponsored] Addressing Placebo Response, Therapeutic Misconceptions and Expectations Singapore’s Tessa raises $80M for T cell therapy push Loxo starts rolling NDA for cancer drug larotrectinib Eyenovia eyes $35M IPO to trial smart ocular delivery tech Featured Story | | | Wednesday, December 20, 2017 AbbVie has scored another key trial win with its blockbuster-in-waiting JAK1 inhibitor upadacitinib (ABT-494), but a death and pulmonary embolism take some of the shine off the data. |
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Top Stories Wednesday, December 20, 2017 Venture capital firm Flagship Pioneering has got a major $618 million in capital, the biggest in its 17-year history, topping its total to $2.3 billion. Wednesday, December 20, 2017 Orchard Therapeutics has positioned itself to join the commercial-stage gene therapy club with a $110 million series B round. The investment gives Orchard the financial firepower to take its gene therapy against adenosine deaminase severe combined immunodeficiency through the final stage of clinical development and onto the market. Monday, December 18, 2017 Randomized, placebo-controlled clinical trials are the most complex step in the development of new drugs. A contributor to trial failure is the increased rate of placebo response, which is now historically high. How can these trends be reversed? Wednesday, December 20, 2017 Emerging immuno-oncology player Tessa Therapeutics has raised $80 million in a financing round that will be used to usher its virus-specific T cell immunotherapies through clinical trials. Wednesday, December 20, 2017 Loxo Oncology has begun a rolling FDA submission for larotrectinib. The move positions Loxo to wrap up the filing for the Bayer-partnered TRK inhibitor early next year. Wednesday, December 20, 2017 Eyenovia has filed to raise up to $35 million in an IPO. The financing will support late-phase trials of candidates based on Eyenovia’s device, which uses inkjet printing technology to deliver small doses of drug to the eye. Resources 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. 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 Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | 