Featured Story | By Amirah Al Idrus Novavax will not file for approval of its COVID-19 vaccine until July at the earliest, thanks to manufacturing issues related to an assay needed to show regulators that its vaccine manufacturing process is consistent across different sites. read more |
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Top Stories By Nick Paul Taylor Ginkgo Bioworks is set to go public through a $17.5 billion merger with a special purpose acquisition company (SPAC). The deal, which involves Arie Belldegrun, will generate $2.5 billion of gross cash proceeds to support Ginkgo’s efforts to engineer cells to enable new product development. read more By Nick Paul Taylor Eli Lilly has struck a deal with MiNA Therapeutics to develop small activating RNA (saRNA) candidates against up to five targets across its key therapeutic focus areas. Lilly is paying $25 million upfront and committing to milestones of up to $245 million per target to work with MiNA. read more By Nick Paul Taylor Nuvalent has raised $135 million to take ROS1 and ALK kinase inhibitors into the clinic. The series B, which comes months after Nuvalent disclosed a $50 million round, sets Nuvalent up to study drugs designed to improve on products such as Roche’s Alecensa and Pfizer’s Xalkori. read more By Annalee Armstrong Cell therapy biotech Acepodia nabbed AbbVie cancer R&D veteran Thorsten Graef as chief medical officer. Graef rose up the ranks after AbbVie’s 2015 acquisition of Pharmacyclics, which brought the blockbuster cancer drug Imbruvica into the pharma giant’s fold. read more By Amirah Al Idrus Having sold off The Medicines Company to Novartis for $9.7 billion last year, former Purdue CEO Mark Timney is taking the helm of yet another biopharma company. He joins Attralus Therapeutics, a company working on new treatments for systemic amyloidosis, alongside several other new hires. read more By Amirah Al Idrus Appia Bio launches with $52 million to develop off-the-shelf cell therapies for cancer based on hematopoietic, or blood-forming, stem cells. Its platform, dubbed ACUA, allows for the programming of stem cells to become invariant natural killer T (iNKT) cells, a rare but powerful subtype of T cell. The company hopes to be in the clinic in 2023. read more By Annalee Armstrong Three years after receiving a gene therapy from Orchard Therapeutics in an early-stage clinical trial, 100% of patients with an inherited disease that damages the immune system were still alive, according to a new study published in the New England Journal of Medicine today. read more By Beth Snyder Bulik Pharma's hockey stick upswing is flattening out, at least reputation-wise. The good news is the industry is still the biggest gainer when it comes to pandemic image-polishing, according to The Harris Poll’s most recent survey. read more By Arlene Weintraub As Novavax prepares to file for FDA emergency use authorization of its COVID-19 shot, the vaccine developer is already looking ahead to the possibility of combining coronavirus and flu protection. In ferrets and hamsters, a flu-COVID combo vaccine produced antibodies against both viruses at levels comparable to what was seen with either component vaccine alone, the company said. read more Resources Sponsored By: Veeva One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster. Sponsored By: Blue Matter This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe. Sponsored by: Datacubed Health The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 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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 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 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 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. | 
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