Today's Rundown Featured Story | Friday, December 13, 2019 After being hit with an FDA rejection for Sarepta Therapeutics' second Duchenne muscular dystrophy drug back in the summer, it looked like a long road, tinged with more than a hint of political intrigue, for it to be approved. |
|
---|
|
Top Stories Friday, December 13, 2019 Amid all the talk about aducanumab and whether it can be approved in Alzheimer’s disease next year in a classic phoenix from the flames tail, Biogen has served up another trial flop. Friday, December 13, 2019 Early data out of former Fierce 15 winner Gritstone Oncology have been heralded as a big win for the early-stage biotech by analysts. Friday, December 13, 2019 A thumping election win for the Conservative Party has positioned the U.K. to push ahead with plans to leave the EU. The new parliamentary arithmetic gives Boris Johnson the numbers to pass the withdrawal agreement and take the U.K. out of the EU, although what will happen after that remains a mystery. Friday, December 13, 2019 Anixa Biosciences has delayed a planned IND filing by 12 months to buy time to improve its CAR-T candidate. The delay will enable Anixa to perform additional genetic engineering intended to boost the efficacy of the treatment in ovarian cancer. Friday, December 13, 2019 Baylor researchers scoured all of the proteins present in 500 diverse cancers and made a surprising discovery: All of those cancers, it turns out, can be slotted into 10 subtypes, each of which is driven by a common set of proteins. The data may lead to new ideas for drug development in ovarian, breast, colon, renal and uterine cancers, they believe. Thursday, December 12, 2019 In this week's EuroBiotech Report, Sanofi inks $2.5B Synthorx takeover and posts sutimlimab data, Roche shares bispecific results and more. Friday, December 13, 2019 AstraZeneca and Daiichi Sankyo turned up "impressive" efficacy data for their antibody-drug conjugate. Janssen and Legend Biotech’s CAR-T therapy cleared multiple myeloma in 69% of patients in phase 1. South Korea jailed Samsung execs for burying evidence linked to a BioLogics fraud probe. Friday, December 13, 2019 Pyxis brings on SpringWorks founder Sullivan; Insitro hires chief data officer Batzoglou; Frinzi to step down from J&J Vision. Resources 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: Clarivate Analytics Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead. Sponsored by: Thermo Fisher Scientific Are you facing costly delays in your API scale-up? Sponsored by: Roche and IQVIA This global landscape study identifies and assesses innovative funding models for cancer and other high-cost chronic NCDs across Africa, Asia, Europe, Latin America and Middle East. The study aims to enable readers to better understand the possibilities that innovative funding models bring to bridge the current and future funding gap, while stressing the key success factors that enable sustainability and success such as stakeholder collaboration. 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. 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 See why visionaries outsource the design and management of the infrastructure allowing their scientists to innovate. Sponsored by: Veeva Systems Medical Affairs 2025 brings together leading perspectives from AstraZeneca, Bristol-Myers Squibb, Merck, Lilly, and other innovative life sciences organizations on key challenges impacting medical affairs and a roadmap for success in the coming decade. Sponsored by: IBM Watson Health IBM’s highlighted solutions reside in a security-rich cloud environment—home for capturing, managing and analyzing clinical study data with control, accuracy and confidence. These solutions lay the groundwork for further integration with IBM® Watson® cognitive technology. Sponsored by: IBM Watson Health Inpatient View and Outpatient View are powered by robust data assets and use sophisticated projection methodologies to help ensure accuracy of reporting. Sponsored by: IBM Watson Health Acknowledging various stakeholder networks, as well as recognizing variances within the regulatory environment, we believe, is essential for companies looking to uncover the right decision-makers in support of biologics or biosimilars. Learn more. Sponsored by: Eli Lilly and Company in partnership with Xcenda Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. |