| This week's sponsor is Rho. | | | [Webinar] Understanding New Drug Applications (NDAs)
Tuesday, August 14 | 1pm ET / 10am PT
Understand what is involved in an NDA including regulatory strategy, data integration and readiness, and electronic publishing, and get tips that can help you avoid common pitfalls in the submissions process. Register Now! |
Today's Rundown Clovis loses Servier pact, agrees to settle SEC case Karuna raises $42M to resurrect abandoned Lilly drug for schizophrenia Sanofi diabetes executive makes the jump to Omeros to become CMO Brexit forces EMA to suspend tasks as job loss forecast jumps Celtaxsys’ cystic fibrosis drug reduces lung exacerbations in phase 2 study Early trial shows application of RXi’s skin-scar drug in wet AMD Lung cell discovery opens new route for cystic fibrosis treatment Featured Story | | | Thursday, August 2, 2018 Clovis Oncology has provided updates on two tarnished drugs that were once central to its plans. The biotech is set to put the rociletinib saga to bed through a $20 million agreement with the SEC, and it will also resume development of lucitanib without the involvement of Servier. |
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Top Stories Thursday, August 2, 2018 Karuna Pharmaceuticals has the cash it needs to start midstage trials of an Eli Lilly drug, shelved because of side effects, as part of a combination therapy for schizophrenia and Alzheimer’s. Thursday, August 2, 2018 In keeping with the recent trend of top R&D executives moving to smaller biotechs, Sanofi’s Eckhard Leifke, M.D., the giant’s global head of diabetes late-stage development, is making the jump to Seattle-based Omeros to become its chief medical officer and VP of clinical development. Thursday, August 2, 2018 The EMA is suffering heavier than expected job losses as a result of its relocation to the Netherlands, forcing it to scale back and suspend more of its activities. International collaborations, development of guidelines and other tasks will slow significantly as the EMA focuses its dwindling resources on key functions. Thursday, August 2, 2018 Celtaxsys’ oral anti-inflammatory drug for cystic fibrosis, acebilustat, cleared a phase 2 study by demonstrating meaningful improvements in pulmonary exacerbations, or the acute worsening of symptoms such as heavy coughing or shortness of breath, combined with sharp decreases in lung function following irreversible organ damage. Wednesday, August 1, 2018 RXi Pharmaceuticals unveiled positive safety and efficacy results in an early-phase study of its antifibrotic agent RXI-109 in patients with advanced neovascular age-related macular degeneration, demonstrating improvements in visual acuity and no drug-related adverse events across escalating doses. Wednesday, August 1, 2018 Scientists already know cystic fibrosis is caused by mutations in the CFTR gene, but they didn’t know where expression of the gene is active. Now, two separate teams have discovered a rare cell type in airway tissue that appears to play a key role in the genetic disorder. Resources Sponsored by: WCG Selecting the right sites is the most crucial decision you’ll make in your next clinical trial, and the single most important factor to consider in selecting a site is whether or not it can meet its enrollment goals. Sponsored by: Veeva Industry Research: See new results from one of the industry's largest, global clinical operations surveys. Sponsored by: Medidata Accelerate Clinical Research as Study Complexity Grows Sponsored by: Veeva Ready to modernize your RIM environment? Secure buy-in with these tips. Sponsored by: Patheon, part of Thermo Fisher Scientific Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies. What should pharma companies look for when navigating this new era of small-volume manufacturing? Here are some ideas to consider when developing a new manufacturing strategy. Sponsored by: Veeva See results from the Tufts eClinical Landscape Study – CRO Report on current data management practices, goals, and challenges for contract research organizations (CROs). Drug Approval, Manufacturing Quality & Regulation 2018 | Online The Life Science Women's Conference August 8-9, 2018 | Austin, Texas BIO Latin America 2018 September 4-5, 2018 | São Paulo, Brazil RESI HealthTech Week September 5-7, 2018 | Boston, MA 4th Annual Bio/Pharmaceutical Product Launch Summit September 25-26, 2018 | Cambridge, MA Drug Development Immersion September 26-27, 2018 | West Windsor, NJ FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Compliance Certification Program at Seton Hall Law October 8-11, 2018 | Newark, NJ The Advanced Biologic Development Summit at Northeastern University October 9, 2018 | Boston, MA BioImmersion: Biotech for the Non-Scientist October 16-18, 2018 | Chicago, IL 2018 BIO Investor Forum October 17-18, 2018 | Westin St. Francis, San Francisco, CA FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Drug Development Boot Camp® 2018 – Register Now! November 14-15, 2018 | Boston, MA | Register now and start your pre-Boot Camp preparation Field Service Amsterdam November 27-28, 2018 | NH Collection Amsterdam Grand Hotel Krasnapolsky | 