Featured Story | | | Wednesday, August 16, 2017 Researchers have raised concerns with the level of evidence needed to win accelerated approval from the FDA. Regulators stand accused of waving through drugs on the basis of slight data and then failing to ensure confirmatory postapproval trials validate the decision. |
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Top Stories Wednesday, August 16, 2017 Zai Lab has filed to raise up to $115 million in a Nasdaq IPO. The biotech plans to use the money to hustle cancer drugs licensed from Bristol-Myers Squibb and Tesaro through late-phase trials in its home country of China. Wednesday, August 16, 2017 Antengene has gained a healthy $21 million series A just a few months after setting up a deal with Celgene. Wednesday, August 16, 2017 Takeda's R&D shake-up continues to rumble on, with the Japanese drugmaker signing a wide-ranging deal that will see it work closely with researchers at Stanford University. Wednesday, August 16, 2017 GlaxoSmithKline and Insilico Medicine are partnering to explore how the latter’s artificial intelligence technology can aid in the drug discovery process. Wednesday, August 16, 2017 Less than a month after welcoming PRA Health Sciences alum Steve Powell as its new CEO, SynteractHCR has tapped Frank Santoro, M.D., most recently Novella Clinical’s CMO, as its CMO. He has more than 30 years of experience in both the CRO and biopharma space, mostly in oncology. Tuesday, August 15, 2017 The word "deal" doesn't just mean the hook-up of two companies. It's also what happens at the card table. Our nominations for best and worst M&A show gambles can pay off—or not—and readers have strong feelings about the players involved. Now's your chance to weigh in. 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. Presented By: MPI Research FierceBiotech interviews Dr. DeWit to discuss a common cause for drug development delays, and strategies to avoid these costly setbacks. 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: 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. FierceBiotech 2nd Drug Development Forum September 25-27, 2017 | Boston, MA 15th Annual Discovery on Target September 25-29, 2017 | Boston, MA FierceBiotech Executive Summit- London October 2, 2017 | London Drug Development Boot Camp® 2017 November 15-16, 2017 | Boston, MA | 