After patients die, FDA clamps hold on Astellas gene therapy trial COVID-19 close-up: Takeda's Morabito on the science behind plasma-based treatments After CureVac nabs government backing, BioNTech sees $250M private investment 2 early-stage biotechs gun for $175M as IPO waters remain warm Heron's wings clipped again with another FDA rejection for opioid alternative Using gene editing to keep cholesterol down and heart attacks at bay With FDA nod, Beckman Coulter plans to ship 30M antibody tests per month Featured Story Monday, June 29, 2020 A second patient has died after receiving Audentes Therapeutics’ gene therapy against a rare genetic neuromuscular disorder. Audentes, which Astellas Pharma acquired for $3 billion, has dropped plans to file for approval imminently and paused a clinical trial while it reviews the situation. read more |
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| Top Stories Monday, June 29, 2020 Hyperimmune globulins work by giving patients a mix of antibodies produced by different kinds of immune cells, so they have multiple different antibodies against multiple different antigens on the virus. Morabito called it a “shotgun approach” that could help patients fight off COVID-19 while researchers are still learning about the disease. read more Monday, June 29, 2020 As two of Germany’s brightest COVID-19 pandemic vaccine biotechs continue to speed on with their clinical work, both have seen big cash injections to help them—but from very different sources. read more Monday, June 29, 2020 If there’s one thing that’s bucking the downward market trend during this pandemic, it's the biotech IPO, and now we have two more phase 1 companies ready to go public. read more Monday, June 29, 2020 After its expected FDA decision date last week came and went and its shares drove downward premarket Monday morning, Heron Therapeutics has been handed a complete response letter from the FDA. read more Monday, June 29, 2020 What if we could replace the arsenal of drugs used to prevent heart attacks with one injection? Verve Therapeutics believes gene "base editing" is the key. In data presented this weekend, the company showed that the approach could switch off either the PCSK9 or ANGPTL3 gene—both of which play a role in heart disease—in monkeys. read more Monday, June 29, 2020 Beckman Coulter received an FDA emergency authorization for its mass-produced coronavirus antibody test, with plans to deliver more than 30 million tests per month worldwide. read more Enrollment Showcase Sponsored by: University of Florida College of Pharmacy University of Florida precision medicine leaders highlight current knowledge and trends to advance the future of health care in this quarterly webinar series. Register today. |
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| Resources Sponsored by: PRA Health Sciences Collaboration across the industry will be key to meeting the demands of the RACE Act and ensuring pediatric patients receive the care and treatments they need. Sponsored by: Systech Get an inside look… Merck shares its next-generation approach to supply chain protection with new digital platforms, including Blockchain. Sponsored by: ICON Download this whitepaper to learn more about the success factors that are required to keep a pandemic respiratory vaccine trial running at optimal speed and efficiency. Sponsored by: Automation Anywhere Built on advances in Artificial Intelligence (AI), data mining, and information integration into various systems at 100% accuracy, the new era of intelligent automation is integral to life sciences for devising new treatments faster and at a lower expense. Sponsored by: Research Solutions Learn four ways to squeeze more value from your limited R&D resources. Sponsored by: BioAnalytix Download this eBook and Learn the Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies Sponsored by: Blue Matter, strategic consultants in the life sciences White paper describing 7 keys to success for any biopharma company that is entering (or thinking about entering) Europe. 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® 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now. | COVID19 provisions – training will be on-site as normal. | New – may be possible for some individuals to access the training virtually in real time. |