This week's sponsor is FierceBiotech. | | | Today's Rundown After disappointing 2016, new drug approvals roared back to life in 2017 New Year biotech IPO hopefuls gun for $369M Kindler’s Centrexion raises $67M to fund phase 3 pain trial Israel’s Protalix claims early success with oral anti-TNF candidate Using an old Merck drug, Menlo hopes to scratch an itch with $98M IPO Last-ditch efforts fail to stop medical device tax Could a three-part diabetes drug ease memory loss in Alzheimer’s? Mallinckrodt inks $1.2B Sucampo buy, ending rough 2017 on a high note Featured Story | Tuesday, January 2, 2018 After a slow 2016, with only 22 new molecular entities, new drug approvals picked back up. Here are the ones that made the grade. |
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| This week's sponsor is Veeva. | | [Webinar] Tufts eClinical Landscape Study: Q&A with Industry Experts January 16, 2018 | 2pm ET / 11am PT Hear expert analysis of the 2017 eClinical Landscape Survey, one of the largest, most in-depth surveys of clinical data management professionals that shows the impact of database build delays on trial timelines, as well as the projected increase of data source usage. Register Now | Top Stories Tuesday, January 2, 2018 Four biotechs spanning a diverse set of therapy targets are seeking out nearly $400 million in a series of IPOs announced just before the New Year. Tuesday, January 2, 2018 Centrexion Therapeutics has raised $67 million. The Jeffrey Kindler-helmed biotech will use the cash to move nonopioid pain drug CNTX-4975 into a phase 3 trial in patients with knee osteoarthritis in the coming months. Tuesday, January 2, 2018 An oral alternative to injectable anti-TNF drugs—a mainstay of inflammatory disease therapy for decades—has shown encouraging activity in a phase 2 trial. Friday, December 29, 2017 Six months after getting off a $50 million series C, late-stage California dermatology biotech Menlo Therapeutics is looking to take advantage of the strong IPO window with a $98 million offering. Tuesday, January 2, 2018 A tax on medical device sales has come into force after a last-ditch effort to extend the suspension fell short. The failure to stop the progress of the tax means manufacturers will have to report sales to the Internal Revenue Service and pay 2.3% on revenues generated by products covered by the levy. Sunday, December 31, 2017 The Alzheimer’s field is littered with drug-development failures, but that isn’t deterring a group of British scientists from looking for hope in an unlikely source: diabetes treatments. The team, from Lancaster University, is reporting that an experimental three-part drug originally developed for use in Type 2 diabetes seems to reverse memory loss in mice. Wednesday, December 27, 2017 Mallinckrodt, which has landed in hot water multiple times this year, is diversifying beyond its controversial lead seller. Enrollment Showcase | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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| 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 Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA Drug Approval, Manufacturing Quality & Regulation 2018 | Online Field Service Medical February 26-28, 2018 | Hilton La Jolla, Torrey Pines, CA |