ASH: J&J, Legend's anti-BCMA CAR-T keeps it consistent in phase 2 as FDA filing looms AbCellera, tapped by Lilly for its COVID-19 antibody therapy, sets IPO terms with $5B valuation After boosting gene therapy focus, Bayer signs up to new cell therapy pact with Atara Sponsored: From Conquering COVID-19 to Curing Cancer, New York City Charts the Future of Life Sciences ASH: Regeneron's bispecific banishes lymphoma—even in patients failed by CAR-T Sponsored: Biotech IPOs: Navigating the New Landscape Not so fast, ALX: FDA pumps the brakes on cancer hopeful 10 months after fast-tracking it ASH: J&J links subcut BCMA bispecific to 73% response rate, plots aggressive investment Maze allies with BridgeBio and Alloy to create 2 biotechs ASH: Kura chalks another one up for menin inhibitors in leukemia Roivant gets $200M for major push into protein degradation Olympus to boost respiratory portfolio with $340M acquisition of Veran Medical Technologies ASH: CRISPR-edited CAR-T cells show enhanced activation against leukemia in mice Featured Story | By Amirah Al Idrus Bristol Myers Squibb and bluebird bio were first to file an anti-BCMA CAR-T for approval, but Johnson & Johnson and Legend Biotech are hot on their heels. The companies unveiled the first phase 2 data for their prospect, which banished multiple myeloma in two-thirds of patients and shrank tumors in 97% of patients. read more |
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| | Balancing Cost, Time and Quality When you support many clinical studies, one thing is certain—you gain experience. Explore critical factors in the packaging design process that can help to deliver the best possible outcome for your study. |
Top Stories By Ben Adams Canada’s speedy R&D engine AbCellera, now world-renowned for its tech producing the Eli Lilly COVID-19 drug authorized by the FDA, has set terms for a monster IPO. read more By Ben Adams German pharma Bayer is moving into cell therapy R&D with its latest pact focusing on tough-to-treat lung cancers with Atara Biotherapeutics. read more Sponsored By: NYCEDC The life sciences sector in New York City is on pace to raise $1B in venture funding in 2020, up from just $40 million ten years ago. In addition to NYC’s outstanding talent and funding, the city is rich with life science real estate offerings across the five boroughs. read more By Amirah Al Idrus CAR-T therapies have been a game changer in certain blood cancers, but they aren't a complete solution. For starters, not all patients can get CAR-T treatment, while others see their cancer worsen despite receiving it. But Regeneron’s bispecific antibody could be a new option for those patients. The drug beat cancer back in two kinds of lymphoma in a phase 1 study. read more Sponsored By: RBC Capital Markets Biotech IPO markets are booming. But even in a boom, identifying the right time to go public and telling your post-IPO story for how capital deployment translates to value for investors is critical. read more By Amirah Al Idrus The FDA granted ALX Oncology’s head and neck cancer program a fast-track tag in February, but, now, it’s telling the company to hold its horses. The agency placed a partial clinical hold on the program, allowing it to enroll a maximum of 50 patients across two pivotal trials while it wraps up a nonclinical safety study. read more By Nick Paul Taylor A subcutaneous formulation of Johnson & Johnson’s BCMAxCD3 bispecific antibody teclistamab has achieved a 73% overall response rate in a small trial of heavily pretreated multiple myeloma patients. read more By Nick Paul Taylor Maze Therapeutics has partnered to create two startups focused on cardiovascular and ophthalmic diseases. The startups will benefit from Maze’s human genetics and functional genomics platform as well as the capabilities of either Alloy Therapeutics or BridgeBio Pharma. read more By Amirah Al Idrus Adults with acute myeloid leukemia (AML) often beat back their cancer with front-line chemotherapy, but many patients relapse and need other options. Early data out of Kura Oncology suggest menin inhibitors could be one of those options. Its drug eliminated tumors in two patients with AML that had come back after previous treatment or hadn’t responded in the first place. read more By Nick Paul Taylor Roivant Sciences has secured $200 million to advance its protein degradation ambitions. Armed with the money, Roivant CEO Vivek Ramaswamy plans to use the VantAI platform to spawn multiple new biotech startups. read more By Conor Hale Olympus’ U.S. division aims to expand its respiratory care offerings with the purchase of Veran Medical Technologies, maker of computer-guided bronchoscopes and cancer biopsy systems. The company described the $340 million acquisition as the latest in a series of deals that over the past year have aimed to focus and scale up its interventional products. read more By Arlene Weintraub Novartis’ CAR-T cancer therapy Kymriah can induce long-term remissions in some blood cancers, but many patients either relapse or don’t respond at all. University of Pennsylvania researchers used CRISPR-Cas9 to eliminate a protein that can stifle the activation of the cancer-killing cells, greatly improving responses in mice. read more Resources Sponsored by: ZS Learn how Aerie fueled their product launches with advanced analytics. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Thermo Fisher Scientific Lack of resources to move from lab concept to the manufacture/delivery of GMP clinical supplies to patients, key milestones can be missed. Sponsored by: Cytiva Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand. Sponsored by: Covance Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Veeva New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress. Sponsored By: BBK Worldwide The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement. Sponsored By: BioAnalytix Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics. Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. Sponsored by: Premier Research Browse the latest learnings and insights from our clinical development professionals. Sponsored by: Rousselot This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Sponsored By: Lonza Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives. Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Outer Edge Technology Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now! Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Fierce JPM Week January 11–13, 2021, 10AM ET | Virtual Event | 