This week's sponsor is FierceBiotech Drug Development Forum. | | FierceBiotech 2nd Drug Development Forum - September 25-27 in Boston 90+ executive-level speakers share advanced partnership and pipeline strategies. Learn to adapt to increased deal complexity, real world evidence and digital technologies. Unequaled networking! Sign up by August 11 to save $200 on registration. | Featured Story | Friday, July 21, 2017 The United Kingdom’s drug regulator is moving its headquarters to within half a mile of the EMA’s current home. Staffers are set to move to their new digs in east London in the middle of next year, shortly before their peers at the EMA are scheduled to leave the city. |
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| Top Stories Friday, July 21, 2017 It's been a big week for Aeterna Zentaris. Fresh from the news that its lead pipeline candidate is back under FDA review with a verdict due before year-end, it's just announced the departure of CEO David Dodd and a strategic rethink. Thursday, July 20, 2017 A phase 2b trial of Ironwood Pharmaceuticals’ IW-3718 has met its primary endpoint, teeing the heartburn candidate up to move into a pivotal trial and on to blockbuster sales. But the positive narrative spun by Ironwood’s management failed to convince investors, who seized on perceived underwhelming efficacy data and drove down the company’s stock. Friday, July 21, 2017 There is no silver bullet to treat metabolic syndrome, a collection of maladies that raise the risk for heart disease and diabetes. But Feinstein Institute-led researchers have come a step closer by using an Alzheimer’s drug to reduce inflammation in people with the syndrome. Friday, July 21, 2017 After outsourcing most of its clinical development efforts to PRA Health Sciences, Takeda is once again seeking outside help, this time in the upper stream, forming a multiyear R&D collaboration with in silico drug discovery expert Schrödinger. Friday, July 21, 2017 Amphora Medical has raised $35.5 million to put its overactive bladder treatment through a pivotal clinical trial. The series B round equips Amphora to take its minimally invasive, cystoscopic device into the last step of clinical development next year. Thursday, July 20, 2017 In this week's EuroBiotech Report, Roche dumps Oryzon, Sanofi and Shire strike deals with European biotechs and more. Friday, July 21, 2017 Takeda is relocating 600 jobs in R&D and 150 in vaccines from suburban Chicago to the Boston area, a U.S. appeals court reinstated a key Velcade patent till 2022, some blockbuster foreign meds became the latest to be added onto China's insurance drug list after taking huge discounts, and more. Friday, July 21, 2017 Ex-Novo U.S. executive Høiland became Radius' CEO, ex-Sanofi Genzyme CEO Meeker joined Trevi as chairman, Myovant Sciences tapped four executives with Big Pharma experience, SynteractHCR named former PRA exec Powell as CEO. Plus more hirings, firings and retirings throughout the industry. Friday, July 21, 2017 Check out Friday's dose of biotech's news of note. Resources Sponsored By: Veeva Learn why 99% of respondents report the need to unify their clinical applications, including CTMS, EDC, eTMF, and study start-up. Sponsored By: DocuSign When leading biopharma companies founded SAFE-BioPharma in 2005, it was with a vision of a not too distant future with major changes in the industry: the move to collaboration with many partners, make business processes fully electronic, and to take advantage of all of the benefits of online operations. Sponsored By: Veeva Learn why 99% of respondents report the need to unify their clinical applications, including CTMS, EDC, eTMF, and study start-up. Sponsored By: HealthCore Gain critical insights into how to design and implement pragmatic trials and generate relevant, high-level real-world evidence. Learn when to conduct PTs, design considerations, ethical regulatory issues — and more. Sponsored By: Envigo Discover the factors that contribute to differential radiation sensitivity between the Rag2 and SCID models. 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. Sponsored By: Veeva Join this global webinar to learn a new approach for demonstrating medical affairs' impact with better metrics - beyond reach and frequency, enabling launch success and better engagement with strategic KOL insights, and increasing your organization's share of voice in the healthcare landscape. Sponsored By: DocuSign DocuSign’s eSignature solutions modernize healthcare and life science organizations by eliminating paper and antiquated signature processes while meeting compliance requirements and reducing costs and errors. Sponsored By: DocuSign The patients who rely on your scientific leadership are expecting more. Sponsored By: DocuSign The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company. Drug Development Boot Camp® 2017 November 15-16, 2017 | Boston, MA FierceBiotech 2nd Drug Development Forum September 25-27, 2017 | Boston, MA |