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Today's Rundown Sanofi's phase 2 MS data spark broad push into late-stage trials GlaxoSmithKline talks up its new R&D focus, keeps mum on M&A targets Roche posts data on SMA rival to drugs from Biogen, Novartis Sonoma Bio debuts with $40M to push Treg treatments for autoimmune, neuro diseases European rare disease biotech Azafaros grabs $28M early funding round FDA grants emergency nationwide use to CDC's coronavirus test GSK cutting 720 jobs in manufacturing, R&D and support functions at massive Belgian vaccine hub Featured Story | | | Thursday, February 6, 2020 A phase 2b clinical trial of Sanofi’s BTK inhibitor SAR442168 in relapsing multiple sclerosis has met its primary endpoint. Sanofi responded to the data by outlining plans to start four phase 3 trials of the Principia Biopharma-partnered asset in relapsing and progressive forms of MS. |
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Top Stories Thursday, February 6, 2020 GSK had a busy day: It announced its fourth-quarter/full-year results along with a split of the company to focus on R&D on one side and consumer health on the other (and maybe sell off its dermatology biz), all the while quietly cutting and scaling back three pipeline efforts. Thursday, February 6, 2020 Roche has presented data from a spinal muscular atrophy clinical trial it hopes will support an FDA approval of its challenger to drugs from Biogen and Novartis. The update adds figures to Roche’s earlier top-line readout but leaves questions about the competitiveness of risdiplam unanswered. Thursday, February 6, 2020 Sonoma Biotherapeutics launched with a mission to create regulatory T-cell treatments for autoimmune and neurodegenerative diseases, $40 million in series A financing and the renowned immunologist, Jeffrey Bluestone, Ph.D., at its helm. Bluestone lands at Sonoma after leading the Parker Institute for Cancer Immunotherapy as its president and CEO. Thursday, February 6, 2020 Azafaros has grabbed €25 million ($27.5 million) in a series A investment boost as it looks to push on with its pipeline focused on rare metabolic disorders. Wednesday, February 5, 2020 The FDA has authorized the nationwide use of the Centers for Disease Control and Prevention’s novel coronavirus diagnostic. Until now, the test could only be used to evaluate nasal or oral swab samples shipped to the agency’s own laboratories. Thursday, February 6, 2020 GlaxoSmithKline’s vaccines unit has been a bright spot for the company amid challenges elsewhere, but its recent performance doesn’t make it immune to staff cuts. The drugmaker this week unveiled a restructuring and up to 720 layoffs. Resources Sponsored by: Medidata To conduct a successful trial, do you need to understand the global eConsent Regulatory landscape? Sponsored by: Veeva Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%. Sponsored by: Quotient Sciences Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL BioBasics 101: The Biology of Biotech March 26-27, 2020 | Boston, MA BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA BIO International Convention June 8-11, 2020 | San Diego, CA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 