Today's Rundown
New (old) CureVac CEO on non-COVID-19 medical leave as plot thickens Pfizer, BioNTech strike COVID-19 deal, commit multiple R&D sites to vaccine development Serious safety issue forces Novo Nordisk to hit pause on late-stage hemophilia trials [Sponsored] Biogazelle launches novel high-throughput RNA sequencing and data analysis services Merck hits goal in cough phase 3 but yet to quash tolerability concern COVID-19 outbreak prompts Provention to pause diabetes trial Sigilon picks up $80M to test hemophilia cell therapy in humans FDA opens the gates to commercial coronavirus testing without agency review The top 10 drugs losing U.S. exclusivity in 2020
Featured Story | | | Tuesday, March 17, 2020 CureVac’s embroilment in a crazy story just got a lot weirder: It lost its CEO two weeks back, who was without warning replaced by its old CEO. Now, he’s out for the foreseeable future with an undefined (but not COVID-19-related) medical issue suddenly stopping him from being chief. |
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Top Stories Tuesday, March 17, 2020 Pfizer has teamed up with BioNTech to co-develop and distribute a mRNA vaccine against COVID-19 outside of China. The partners plan to use multiple R&D sites in the U.S. and Germany to accelerate the progress of a vaccine that is due to begin clinical testing in humans by the end of April. Tuesday, March 17, 2020 Novo Nordisk has halted one midstage and two late-stage tests of its bleeding disease drug concizumab after seeing blood clots in some patients. Monday, March 16, 2020
Biogazelle NV, a CRO specializing in genomics and transcriptomics, announced the launch of HTPathwaySeq and HTTargetSeq, two cost-effective high-throughput RNA sequencing and data analysis services. Tuesday, March 17, 2020 Merck has linked gefapixant to statistically significant improvements in chronic cough patients in two phase 3 trials. The results cement Merck’s status as the front-runner in the race to develop a P2X3 receptor antagonist but suggest there are enough chinks in its armor to encourage the chasing pack. Tuesday, March 17, 2020 As the race toward a drug for COVID-19 heats up, some biopharma companies are feeling the heat from the outbreak. Provention Bio is one of them—the autoimmune disease player has hit the brakes on a phase 3 study for its diabetes treatment “out of an abundance of caution.” Tuesday, March 17, 2020 Sigilon raised $80.3 million to advance its encapsulated cell treatments. The funding will push its lead program, a treatment for hemophilia A, into the clinic in the first half of this year and bankroll IND-enabling studies for Sigilon’s earlier-stage programs. Tuesday, March 17, 2020 In the face of urgent need, the FDA has opened its floodgates to commercial coronavirus testing. The agency is now allowing companies to proceed with their diagnostic tests without first submitting them for federal review or obtaining an official emergency clearance.
Each year, drugmakers lose their monopolies on a slate of big-selling old medicines. While top brands like Lyrica and Herceptin lost exclusivity last year—and more big rollouts are expected for 2021 and beyond—this year's exclusivity losses will cause some significant pain of their own.
Enrollment Showcase | | | Presented by: Global EMBA for Healthcare & the Life Sciences, University of Toronto
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Resources Sponsored by: eClinical Solutions
Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor. 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. 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 about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Outer Edge Technology
See why innovative BioPharma’s are partnering with Cloud Service Provider’s to design, manage and implement cloud strategies to smooth the path to FDA approval and enhance their competitive prowess. Sponsored by: Metabolon
Metabolomics can help you streamline your drug development process by providing the framework to make a stronger, more confident, and more valuable case for a molecule in a shorter timeframe. Sponsored by: Epsilon
Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing. Sponsored by: Reprints Desk/Research Solutions
3 ways you may be overspending on scientific literature access, and how to fix them. Sponsored by: Baxter
When different drug products are produced in shared facilities, potential for cross-contamination needs to be addressed. Outsourcing to a CMO with experience in multiproduct facilities can be an option. Sponsored by: WCG Metrics Champion Consortium
Ineffective measurement could mean wasting both time and money. This whitepaper showcases a custom-built Metric Maturity Model that helps illustrate and define the process for measuring the right things the right way. Sponsored by: Eagle Productivity Solutions
Mediocre adoption rates aren’t due to poorly designed software or lazy users. They’re the result of how skills are trained. Achieve high adoption rates by implementing the right methodology with a focus on behavior change. Sponsored by: The Kinetix Group
Read about the innovative ways payers are making smart moves in the healthcare game. Sponsored by: Catalent
This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Sponsored by: Blue Matter Consulting
White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done. Sponsored by: Catalent
Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent
Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. 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: 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.
Bioprocessing Summit Europe – Practical Solutions for Today’s Bioprocess Challenges March 24-26 2020 | Barcelona, Spain BioBasics 101: The Biology of Biotech March 26-27, 2020 | Boston, MA Clinical Trial Innovation Summit – Technology, Data, Operations, Oversight April 6-8, 2020 | Cambridge, MA Medical Affairs Strategic Summit (MASS) East April 14-16, 2020 | New Brunswick, NJ BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA European Healthcare Compliance Certificate Program June 2-5, 2020 | Paris, France U.S. Healthcare Compliance Certificate Program June 8-10, 2020 | Newark, NJ BIO International Convention June 8-11, 2020 | San Diego, CA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 