| This week's sponsor is Premier Research. | | | Atopic Dermatitis: Where Do We Go From Here?
Improved understanding of atopic dermatitis is revealing new insights and treatment options. Get current by downloading our white paper examining these exciting and emerging therapies. Premier Research. It's what we do. Best. |
Today's Rundown Roche dumps 4 eye, CNS and cancer drugs in Q4 clear-out Avrobio pulls in $60M to push Fabry, Gaucher candidates through the clinic Voyager founder and CEO to step down, no replacement yet Vertex picks drugs for mass-market cystic fibrosis combinations on back of strong midphase data AstraZeneca, Syndax ally to test PD-L1 drug and CSF1R inhibitor in solid tumor patients MIT study finds that 14% of trials see approvals—higher than first thought Repairing mutation ‘clusters’ with CRISPR could lead to broader Duchenne therapy Featured Story | | | Thursday, February 1, 2018 Swiss major Roche announced its financials today, and buried within its pipeline updates the company announced it was dumping a host of early- and late-stage candidates. |
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| This week's sponsor is Dell EMC. | | | [Webinar] Is Your Life Science Data "F-A-I-R"?
Tuesday, February 13 | 2pm ET / 11am PT
Is Your Life Science Data "F-A-I-R"? Join DataFrameworks & Dell EMC in this webinar to discover a new approach to create scientific data that is findable, accessible, interoperable, and reusable. Register now! |
Top Stories Thursday, February 1, 2018 With the financing, Avrobio plans to push its pipeline through the clinic "as aggressively as possible." Its Fabry treatment will enter phase 2, while its Gaucher and cystinosis programs will start phase 1 trials. Thursday, February 1, 2018 A few months after Sanofi said it didn’t want to be involved with its gene therapy for Parkinson’s, Voyager Therapeutics’ chief and founder Steven Paul, M.D., is stepping down to become an “executive science advisor.” Thursday, February 1, 2018 Vertex has picked the two next-generation correctors it will advance into phase 3 cystic fibrosis trials. VX-659 and VX-445 landed spots in experimental triple combinations designed to treat 90% of cystic fibrosis patients after delivering strong efficacy data in midphase trials. Thursday, February 1, 2018 AstraZeneca and Syndax have teamed up to test immune checkpoint inhibitor Imfinzi in combination with CSF1R inhibitor SNDX-6352. Syndax is set to put the cocktail through a phase 1b solid tumor trial to equip both companies to sponsor midphase trials to demonstrate its safety and efficacy. Thursday, February 1, 2018 A 14% approval rate for drugs coming out of clinical trials may not sound great, but researchers at the Massachusetts Institute of Technology say this is much higher than they thought, and that approvals are bouncing up again after a period of decline. Wednesday, January 31, 2018 Targeting "clusters" of mutations in the dystrophin gene could lead to a treatment for as many as 60% of patients with Duchenne muscular dystrophy, compared to the 13% of patients for whom Sarepta's Exondys 51 is indicated. CRISPR is the key to achieving this, say UT Southwestern researchers. 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: Agilent This Agilent intact protein analysis includes: 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: Patheon Download Patheon’s whitepaper to discover two main areas where a drug developer can face significant obstacles during biologics development and how by evaluating these capabilities, it can answer the critical question of whether its in-house strategy is ready for these uncertainties. Presented by: SDC and Stiris Research What do you do when timelines are missed, data is dirty, and everyone is pointing fingers? Join this webinar to learn how to prevent, identify, and implement a successful clinical trial rescue. Sponsored by: Veeva Systems Expanding into new markets places a spotlight on inefficient processes. 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 Approval, Manufacturing Quality & Regulation 2018 | Online TMF Operations: a Quality and Regulatory Approach March 19 - 21, 2018 | Berlin, Germany
Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel | 