Today's Rundown Roche's risdiplam clears another phase 3, setting up SMA showdown with Biogen and Novartis Merck KGaA spinout iOnctura raises cash for cancer trials In conversation with Myrtle Potter, CEO of Sumitovant Summit Therapeutics tops up C. diff war chest with $8.8M BARDA funding Hey Sanofi, you need to freshen up your pipeline, perhaps with M&A: report FDA approves Medtronic's tiny, wireless, minimally invasive pacemaker implant Featured Story | | | Thursday, January 23, 2020 Roche’s risdiplam has come through another late-phase test, triggering improvements in the motor skills of infants with type 1 spinal muscular atrophy. The clinical success comes months before the FDA is set to decide whether to approve the survival motor neuron-2 splicing modifier. |
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Top Stories Thursday, January 23, 2020 Merck KGaA spinout iOnctura has raised a €15 million ($17 million) series A round to support an early-phase solid tumor trial. The company is gearing up to generate data on PI3Kδ inhibitor IOA-244 in humans while hustling a second candidate through IND-enabling studies. Thursday, January 23, 2020 Sumitovant CEO Myrtle Potter discusses the $3 billion deal between Roivant and Sumitomo Dainippon that set up Sumitovant, a new umbrella containing five Vants now owned by the Japanese Pharma, as well as her role at Sumitovant and what's up in 2020. Thursday, January 23, 2020 Antibiotics player Summit Therapeutics is gearing up for a new clinical trial of its lead asset, an antibiotic for Clostridium difficile infection, thanks to an $8.8 million cash infusion from the U.S. Biomedical Advanced Research and Development Authority. That study, to be done in adolescents, will be part of the new drug application for ridinilazole. Thursday, January 23, 2020 More than 75% of Sanofi's sales come from products over 10 years old—a quandary that can't be solved unless the French pharma giant embraces M&A to boost its pipeline, said analysts at Vantage. Which company offers the best model for using deals to freshen up the pipeline? That would be Gilead, they said. Thursday, January 23, 2020 The FDA approved a new, tiny pacemaker from Medtronic that does not require the wiring of separate electrodes between the implant and the heart. Less than one-tenth the size of traditional pacemakers and described as one of the world’s smallest, the Micra AV device is designed to be placed entirely within the heart’s right ventricle. 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: 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: DocuSign A digital transformation is taking place in the life sciences industry, from research laboratories to manufacturing facilities. But there has always been a gap in these technologies. Download the whitepaper to learn how this challenge was addressed. Sponsored by: DocuSign This paper discusses some of the challenges that the GDPR will introduce, with a particular focus on its requirements for obtaining verifiable, unambiguous consent. Sponsored by: DocuSign Download this paper to learn how you can fully digitize all paper processes. By doing so, you will see shorter cycle times, reduced development costs, and greater customer satisfaction. Sponsored by: Benchling As emerging modalities transform the needs of life science R&D, how can biotech and pharma companies use modern software approaches to increase productivity and reach breakthroughs faster? 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: ICON Clinical Research Ltd The beginning of this digital transformation is well underway and is likely to accelerate. Read our white paper, “Digital Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D,” to learn more. Sponsored by: snapIoT, Inc. Download this white paper and read the expert feedback that snapIoT has gathered from industry thought leaders on the evolution, evaluation, and use of telemedicine solutions in clinical trials. Sponsored by: EVERSANA How are your launch strategies can convert “innovation” into value for patients? Sponsored by: Amazon Web Services From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks Sponsored by: Outer Edge Technology, LLC Why companies leverage the expertize of industry focused cloud service providers to design and build quality systems and facilitate the FDA Validation of Mission Critical Apps in the Cloud. Sponsored by: Colorcon Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication. Sponsored by: Metabolon Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor. 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. Asia-Pacific Healthcare Compliance Certificate Program March 9-12, 2020 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL 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. Middle East Healthcare Compliance Certificate Program March 23-26, 2020 | 