This week's sponsor is TD2. | | | Today's Rundown Concert rethinks R&D plans after loss in Incyte patent case Forty Seven lines up Roche as second partner for CD47 cancer immunotherapy Aradigm crashes after FDA panel votes down antibiotic [Sponsored] INNOVATION BY DESIGN Decoding cancer-linked enzyme could lead to better EGFR cancer drugs New tools for turning genes into drug factories Boston Scientific wins FDA clearance for electric pulse system for nonopioid pain management EuroBiotech Report—Novo-Ablynx, Takeda-TiGenix, Scancell-BioNTech, Sanofi-Alnylam and Boehringer FiercePharmaAsia—Takeda deals, blockbuster China nods, Sanofi European generics suitors Chutes & Ladders—Pfizer oncology head Liz Barrett jumps ship to Novartis Featured Story | Friday, January 12, 2018 Concert Pharmaceuticals is reassessing whether to expand CTP-543 into additional indications after its attempt to challenge an Incyte patent failed. The setback leaves Concert committed to taking the drug forward in alopecia areata but uncertain of its future beyond the indication. |
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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 Friday, January 12, 2018 Forty Seven has added Roche to its partner list for its CD47-targeted immuno-oncology candidate, with Roche’s Genentech unit agreeing to sponsor two trials of the antibody in combination with its PD-L1 inhibitor Tecentriq. Friday, January 12, 2018 A FDA expert committee has voted against Aradigm’s inhaled formulation of ciprofloxacin. Most of the panel felt Aradigm failed to provide substantial evidence of the safety and efficacy of Linhaliq in delaying the first exacerbation in patients with chronic lung infections. Monday, January 8, 2018 Astellas, like many of our industry peers, prioritizes innovation. What sets Astellas apart, however, is how we function at the intersection where our “Science First” approach meets the flexibility we’ve built into our innovation infrastructure. Friday, January 12, 2018 NIH scientists have modeled the 3D structure of DHHC enzymes, which modify nearly 1,000 human proteins, including EGFRs, a family of receptors that are implicated in a range of cancers. Thursday, January 11, 2018 Synthetic biologists have long dreamed of designing genetic circuits in the body that can produce drugs in response to environmental cues. But it’s been a challenging task. Now scientists at Rice University say they have created a toolkit of gene “promoters” that can turn genes on and off at command. Friday, January 12, 2018 The FDA gave the green light to Boston Scientific’s first-of-its-kind electric pulse system designed to treat pain without the use of opioids. Thursday, January 11, 2018 In this week's EuroBiotech Report, Ablynx rebuffs €2.6 billion Novo bid, Takeda inks €520 million TiGenix buyout and more. Friday, January 12, 2018 Takeda, which just reached a neurodegenrative deal with Denali, is buying up TiGenix; Opdivo and Lynparza are among 16 potential blockbuster nods in China this year; several Indian and Chinese firms are reportedly eyeing Sanofi's European generics unit; plus more news from Asia's pharma industry. Friday, January 12, 2018 Novartis poached Pfizer oncology head Liz Barrett, Ed Kaye re-emerged as CEO of genetic disease startup Stoke Therapeutics, Perrigo hired pharma packaging company executive Uwe Röhrhoff as CEO; plus more hirings, firings and retirings throughout the industry. This week's sponsor is Protea Biosciences. | Protea's “BIOPHARMA” Assets Available For Sale in Morgantown, WV (Ch. 11 Debtor) Cancer-Diagnostic Protocols, Lab EQ, & Licenses ($1.15MM Min) Stalking Horse Bid at $1.0MM Already Filed; Sale Hearing Date 01/24/18 Small Molecule Analytics Business, EQ, & Cust. AR + $75.0MM NOLs ($1.0MM Min) All assets to be sold via 363-Sale Auctions (No. Distr. of WV BK Court - Case: 17-1200) Bids are due by January 18, 2018 (Unless Extended) Contact: Jack Teitz, CRO for Additional Information: 412-855-7625 | 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: Seton Hall Don’t miss this educational program trusted by multi-national companies as part of their employee’s compliance training. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating in the Asia-Pacific region. Visit event page for session topics. Presented by: SDC and Stiris Research What do you do when timelines are missed, data is dirty, and everyone is pointing fingers? From study delays to quality issues, sponsors can find their studies at risk with no clear solution. Sponsored by: Veeva Systems Expanding into new markets places a spotlight on inefficient processes. Sponsored by: Agilent This Agilent intact protein analysis includes: Sponsored by: Veeva Systems Regulatory leaders share challenges and best practices from a lack of standardization, manual processes, and fragmented systems. 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: 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. 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: 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. Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA Drug Approval, Manufacturing Quality & Regulation 2018 | Online TMF Operations: a Quality and Regulatory Approach March 19 - 21, 2018 | Berlin, Germany
Field Service Medical February 26-28, 2018 | Hilton La Jolla, Torrey Pines, CA |