|  | Finding the right patients for a particular clinical trial involves precision, timeliness and is one of the most important hurdles to successful clinical development. Learn more about early indicators of efficacy and more from a free white paper by TD2. |
Featured Story | By Ben Adams German biotech CureVac shouldn’t be discounted from being a major COVID-19 vaccine player despite being at the tail end of the race to market. read more |
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 | Thank you to Catalent for sponsoring this year's JPM 2021 coverage. |
Top Stories By Conor Hale Alongside hopes that it will soon have a new drug for Alzheimer’s disease speeding to market, Biogen has announced a new research project with Apple to see whether the company’s iPhones and smartwatches can help monitor users for declines in cognitive health. read more By Amirah Al Idrus The COVID-19 pandemic has spurred enormous interest and innovation in vaccines, antivirals and anti-infective drugs and for obvious reasons. There’s another area that might have been buoyed by the threat of a new illness that had no specific treatments—but wasn’t. That area, of course, is antibiotics development. read more By Nick Paul Taylor Celltrion’s anti-SARS-CoV-2 antibody has improved outcomes in patients with mild to moderate COVID-19 in a phase 2/3 clinical trial. The Korean biopharma reported lower rates of progression to severe COVID-19, shortened time to clinical recovery and reduced viral load in patients on the drug. read more By Amirah Al Idrus All eyes are on Biogen’s aducanumab as the FDA’s decision date for the controversial Alzheimer’s drug looms. Industry watchers and executives are hopeful for an approval come March, partly because of a dearth of approvals since that of Namenda (memantine) nearly 20 years ago. read more By Amirah Al Idrus COVID-19 threw a wrench in Imara’s plans. The company was testing a treatment for sickle cell disease—which occurs more often in people of African descent—during a pandemic that disproportionately affected communities of color. But it learned some lessons along the way that aren’t just useful for its own work, but for anyone working on drugs for diverse populations (so really, anyone working on drugs, period). read more By Nick Paul Taylor IO Biotech has raised €127 million ($155 million) to fund clinical development of immune-modulating IDO and PD-L1 cancer vaccines. The series B financing round comes months after IO Biotech showed combining its IDO and PD-L1 vaccines with Opdivo triggered complete responses in 45% of stage 4 melanoma patients. read more By Ben Adams Amgen has penned a deal worth $240 million-plus with biotech Evoq Therapeutics as it looks to the future for autoimmune research. read more By Ben Adams Gilead and trendy biotech Vir Biotechnology are teaming up in the effort to find a cure to the liver disease hepatitis B. read more By Arlene Weintraub A year ago, Vir Biotechnology CEO and Biogen veteran George Scangos was presenting early data on the startup’s antivirals to treat HIV, flu and hepatitis B. Then COVID-19 hit. Now Vir and its partner GSK have an antibody in phase 3 testing that Scangos believes could rival antibodies from Regeneron and Eli Lilly. read more By Angus Liu Scientists from the University of Bonn, the Karolinska Institutet and Scripps Research Institute have designed a COVID-19 treatment by fusing "nanobodies" from a llama and an alpaca. In lab experiments, the engineered antibodies were able to neutralize emerging mutants of the novel coronavirus. read more By Ben Adams Contract research organization PPD said that while the pandemic is surging again across the world, lessons since March put the industry in a better position to keep trials going, as it says approvals for new vaccines haven’t and won’t lead to a letup in its COVID-19 trial work. read more By Ben Adams,Conor Hale Welcome to Day 3 of the annual J.P. Morgan healthcare conference. Here's your need to know, as Bayer says CureVac is not just an also-ran in the mRNA COVID-19 vaccine race while Aridis’ CEO says the pandemic has lamentably not secured more interest in antibiotic R&D. read more Resources 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: Blue Matter Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.” Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: GenScript A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields. Sponsored by: Catalent Cell and gene therapies hold the promise to offer novel therapeutic avenues for individuals facing serious medical conditions, but bringing them through the clinical trial process introduces a level of supply chain risk and complexity. Sponsored by: AllianceRx Walgreens Prime Gene and cell therapy are shifting paradigms for manufacturers, patients, healthcare providers and pharmacies. We invite you to learn more by reading Gene and Cell Therapy: A New Age of Medicine. 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: Metabolon Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline. 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: 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: 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: 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 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. | 
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