Merck takes $170M charge on abandoned COVID-19 drug Novavax shares in the red after vaccine sees 51% efficacy against South African COVID variant Bluebird names oncology spinoff, establishes leadership team Sponsored: Mitotech brings novel approach to treating eye disorders Sanofi kicks off new immunology research journey with Stanford pact Sponsored: Risk Mitigation in Direct-to-Patient Clinical Trials Dyno grabs $100M to expand tech, build team, ink more gene therapy partnerships Biden admin backs proposal to suspend intellectual property on COVID-19 vaccines, angering industry Medtronic debuts virtual spinal cord stimulation treatment guide A cancer vaccine built from stem cells? Stanford candidate shows promise in pancreatic tumors Featured Story | By Nick Paul Taylor Merck has recorded a $170 million charge related to the discontinuation of the COVID-19 candidate it acquired in the takeover of OncoImmune. The action means Merck has taken hundreds of millions of dollars in charges on failed COVID-19 bets in recent months. read more |
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Top Stories By Ben Adams While the world (and the biotech’s investors) wait for full data and possible filing for emergency use of Novavax’s NVX-CoV2373, it has dropped more data on how its shot works against a particular variant. read more By Nick Paul Taylor Bluebird bio has disclosed the name of its oncology spinoff: 2seventy bio. The spinoff is taking cancer therapies and some executives, including the CEO and chief scientific officer, from bluebird. read more Sponsored By: Mitotech S.A. Mitotech focuses its clinical development efforts on ophthalmology, hoping to deliver its mitochondria targeted therapies to patients suffering from age-related as well as rare genetic eye diseases. read more By Annalee Armstrong Sanofi has signed a new scientific exchange pact with Stanford Medical to research three areas of immunology as part of the French pharma's pivot from the diabetes and cardiovascular disease areas. read more Sponsored By: Catalent Clinical Supply The COVID-19 pandemic has made society very aware of the need to be flexible in the approach to daily life. Use and acceptance of DTP has grown due to the pandemic, and sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes. read more By Amirah Al Idrus Dyno Therapeutics emerged last year with a modest seed round and Big Pharma partnerships to fuel its work designing new and improved viral vectors to deliver gene therapy. Now, the company is kicking it up a notch with a $100 million financing to expand its platform into new tissues, build its team and ink more partnerships. read more By Eric Sagonowsky Bucking the pharma industry on the closely watched issue of patent rights for COVID-19 vaccines, the Biden administration came out in favor of a proposal at the World Trade Organization to suspend intellectual property protections for pandemic shots. read more By Conor Hale The CareGuidePro program allows healthcare providers to help manage and personalize therapy by collecting real-time feedback. read more By Angus Liu A team at Stanford University showed that a cancer vaccine made from induced pluripotent stem cells, together with an immune adjuvant, could protect against pancreatic cancer in mouse models. It induced strong T-cell and antibody responses while dialing down immune suppressor cells. read more Resources Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: ClearView Healthcare Partners As clinical treatment options become more patient-centric, digital therapeutics provide forward-looking biopharma players the opportunity to augment the value of their offerings to stakeholders. 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. 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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. Sponsored By: Culture Biosciences Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. 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. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. TMF Virtual Summit May 18-20, 2021 | Virtual Event Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 12 p.m. EST / 9 a.m. PST Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9 a.m. EST / 6 a.m. PST Biopharma Supply Chain June 29-30, 2021 | Virtual Event | 