| 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 Biotech veteran Gilman is back, heading up next-gen CAR-T startup Obsidian After Synta merger, Madrigal’s NASH drug hits liver fat in midstage test U.K.’s Brexit skeptic defying biopharma deal splash fizzles Amgen, Carmot ink backloaded $240M Parkinson’s pact Galectin plunges on NASH cirrhosis midstage miss Quebec's Amorchem sets up $44M+ life sciences VC On back of Roche pact, newly formed Ncardia wins iPSC deal with Evotec FDA releases long-awaited guidance on 3D printed products Featured Story | | | Wednesday, December 6, 2017 Michael Gilman went into retirement when Bristol-Myers Squibb bought out his Padlock Therapeutics venture last year, but has made a comeback at the helm of a new company promising to transform cell and gene therapies. |
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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 Wednesday, December 6, 2017 Madrigal Pharmaceuticals has seen some positive snapshot data coming out of its phase 2 fatty liver disease test using an old Roche medication. Wednesday, December 6, 2017 The United Kingdom government has unveiled its highly anticipated deal with the life sciences sector. As previously leaked, the document details planned investments from drug developers including GlaxoSmithKline, although many of the commitments are vague or already known. Wednesday, December 6, 2017 Amgen has struck a deal with Carmot Therapeutics worth a potential $240 million. The alliance tasks Carmot with using its lead-identification technology to provide Amgen with a stream of prospects against conditions including Parkinson’s disease. Tuesday, December 5, 2017 Galectin Therapeutics was down nearly 50% in premarket trading Tuesday on the news that its lead fibrosis candidate missed the primary endpoint of a phase 2b trial in NASH cirrhosis. Wednesday, December 6, 2017 With the launch of its $44.2 million life sciences venture capital fund, the AmorChem Group now has $86 million under management. Wednesday, December 6, 2017 Less than three months after coming to life via a merger of Pluriomics and Axiogenesis, human-induced pluripotent stem cell expert Ncardia has signed disease-modeling licensing deals with Roche and Evotec. Wednesday, December 6, 2017 In a much-anticipated action, the FDA released its first-ever technical guidance for manufacturers using 3D-printed technology for medical products that include devices, medication and human tissue. 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. 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 | 