The annual ASH meeting has become one of the year’s most exciting conferences, and on the cutting edge of cancer-killing cell therapies. This week, Gilead showed how a single infusion of Yescarta extended lives by over two years in patients with relapsed large B-cell lymphoma. Meanwhile, Bristol-Myers upcoming CAR-T therapy erased signs of the same blood cancer in more than half of patients. At the same time, Janssen’s CAR-T eliminated multiple myeloma in 69% of cases in a small phase 1 trial. These astounding data, and the rest of our top stories of the week, follow below. | |
| Featured Story | Sunday, December 8, 2019 ORLANDO, FLORIDA—How long can a single infusion of CAR-T drug Yescarta continue helping patients with refractory large B-cell lymphoma? Pretty long, Gilead Sciences showed Saturday. Nearly half of patients treated with Yescarta more than three years ago—47%—were still alive at a median follow-up of 39.1 months. |
|
---|
|
Top Stories Of The Week Saturday, December 7, 2019 In a newly unveiled study, Bristol-Myers Squibb’s CAR-T therapy banished tumors in more than half of relapsed blood cancer patients and shrank tumors in nearly three-quarters of them. The treatment, picked up in the company’s $74 billion Celgene buyout, could help patients with large B-cell lymphomas whose disease has worsened despite trying other treatments. From Big Pharmas like Novartis and Gilead to liver specialists and one-asset biotechs, it seems like everyone in biopharma has some skin in the NASH game. This report examines the top prospects in the NASH pipeline, and why we even need a drug for nonalcoholic steatohepatitis in the first place. Tuesday, December 10, 2019 When Novartis unveiled its $9.7 billion buyout of The Medicines Company a few days ago, several industry watchers suggested the price was too high. Turns out, Novartis' own number-crunching "could not justify $85 per share" for the PCSK9 drug developer, SEC documents show—but even so, the company at one point offered as much as $90. Saturday, December 7, 2019 Janssen’s BCMA-targeting CAR-T therapy eliminated tumors in 69% of patients with advanced multiple myeloma in a small phase 1 study. The treatment, which also shrank tumors in all 29 of the patients, kept cancer at bay in 93% of patients six months after dosing. Tuesday, December 10, 2019 Sanofi spent months hyping its Tuesday investor event, and new CEO Paul Hudson certainly laid out a different vision for the drugmaker at the confab. The company has long been a leader in diabetes and cardiovascular diseases, but it won't be focused there going forward. Instead, it's focusing on rare diseases, cancer, and transformative launches. Tuesday, December 10, 2019 As its new CEO begins to move Sanofi away from new diabetes research, the drugmaker—and producer of one of the world’s top-selling insulins—will also look to pull back from its three-year-old relationship with Verily and their virtual diabetes clinic, Onduo. Wednesday, December 11, 2019 Sanofi, which has moved purposefully into high technologies to get more from its manufacturing, will lean even more on that strategy to save costs and fatten margins. Using robotics, artificial intelligence and new generation manufacturing should save it half a billion euros in annual costs by 2022. Friday, December 6, 2019 Biogen has shared the detailed data on aducanumab that it hopes will secure FDA approval in Alzheimer’s disease. The Clinical Trials on Alzheimer's Disease presentation cleared up some questions about the data set without delivering a telling blow for either side of the debate. Friday, December 6, 2019 Noninfectious viruses used to deliver gene therapy can still sometimes touch off dangerous immune responses. A team from Johns Hopkins Medicine has developed an alternative method for transporting large therapies into cells—including genes and even the gene-editing system CRISPR. It’s a polymer nano-container that biodegrades inside of cells. Friday, December 6, 2019 On the heels of an FDA speedy review for Keytruda’s potential use in non-muscle invasive bladder cancer, its close rival, a gene therapy by Ferring Pharmaceuticals spinout FerGene, has posted competitive late-stage data. But Merck has at least one upper hand. 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: 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. |