| This week's sponsor is Premier Research. | | | Studying an Addiction Drug? Some Practical Tips To Help
Developing drugs to treat addiction is a complex challenge, and sponsors benefit when they know how addiction trials work. Read our white paper for a closer look. Premier Research. It's what we do. Best. |
Today's Rundown Building on Cures Act, FDA lays out cell therapy fast track in regenerative medicine framework Pentagon will not decide on battlefield drug/device approvals Ionis licenses another antisense GI drug to Janssen [Sponsored] Looking Toward Abuse Deterrent Opioids FDA OKs behind-the-ear device for opioid withdrawal EuroBiotech Report—Bayer-Loxo, CRISPR-CureVac, Gates’ Alzheimer’s investment, Novartis and Macrophage FiercePharmaAsia—Pfizer’s China JV, Otsuka-Proteus' digital pill, Astellas’ charity donations Chutes & Ladders—Pfizer creates COO role for potential CEO successor Featured Story | | | Friday, November 17, 2017 The FDA has created a policy framework for cellular therapies and other regenerative medicines by releasing two draft and two final guidance documents. Publication of the texts builds on the 21st Century Cures Act by setting criteria for the new Regenerative Medicine Advanced Therapy designation and outlining the benefits of the regulatory status. |
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| This week's sponsor is Deloitte. | | | |
Top Stories Friday, November 17, 2017 Controversial plans to allow the Pentagon to approve drugs and medical devices intended for use by soldiers have been set aside in the latest version of a bill approved this week by the House of Representatives. Friday, November 17, 2017 Ionis Pharmaceuticals has signed the rights to a second antisense drug over to Janssen for a fee of $5 million. Monday, November 13, 2017 The complex and intertwined dual epidemics of poorly treated pain and opioid addiction require a combined, artful approach to secure the best possible results for patients. Friday, November 17, 2017 Innovative Health Solutions' nerve field stimulator sends electrical impulses to cranial nerves to treat opioid withdrawal. Thursday, November 16, 2017 In this week's EuroBiotech Report, Bayer spends big on Loxo drugs, CureVac lands Cas9 deal, Gates invests in Alzheimer’s and more. Friday, November 17, 2017 Pfizer sold all of its 49% stake in a Chinese joint venture with Zhejiang Hisun Pharma, the FDA approved the U.S.’s first digital medicine by Otsuka and Proteus, Astellas joined a long list of industry big names under investigation for their copay charity donations, and more. Friday, November 17, 2017 Pfizer creates a COO role for CEO Ian Read’s suspected successor, Bayer replaces its consumer health chief with a Nestle veteran as business lags, Turnstone Biologics poaches a Bristol-Myers Squibb executive as new R&D chief, plus more hirings, firings and retirings throughout the industry. | This week's sponsor is Charles River. | | | |
Resources Sponsored by: Reprints Desk 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. 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. Sponsored by: Veeva CROs are leading an industry wide shift to modernize clinical systems and clinical trial processes. 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. BioBasics: Biotech for the Non-Scientist November 30-December 1, 2017 | Boston, MA CBI’s Commercial Data Insights 2017 November 28-29, 2017 | Philadelphia, PA FierceBiotech Executive Breakfast: Get Good Science and the Money will Follow January 9, 2018 | San Francisco, CA Register Today – ISPE Biopharmaceutical Manufacturing Conference December 4th-6th, 2017 | San Francisco, CA BIO Asia International Conference March 19-20, 2018 | Tokyo, Japan Molecular Med Tri-Conference February 11-16, 2018 | San Francisco, CA | 