Featured Story | By Ben Adams “Lockdown” has been named the Collins Word of the Year 2020. At Fierce Biotech, the word our team has been writing the most is, in fact, not even a word, but an abbreviation: COVID-19. read more |
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Top Stories By Amirah Al Idrus The world is watching and waiting for data to see whether Gilead's investigational antiviral remdesivir can help fight COVID-19. And while some leaked early results suggest that it can, industry watchers will need to wait for data from Gilead's own controlled phase 3 study to know for sure. read more By Ben Adams After having to halt enrollment in its severe COVID-19 trial due to a lack of patients, a second test of Gilead’s old Ebola drug remdesivir has befallen the same fate, this time in patients with a milder form of the disease. read more By Nick Paul Taylor Researchers at the University of Oxford have begun enrolling subjects in a phase 2/3 clinical trial of AstraZeneca-partnered COVID-19 vaccine AZD1222. The next stage of the program, which follows a 1,000-subject phase 1, is set to enroll 10,260 people in the U.K. to generate results to support the first shipments to customers in September. read more By Nick Paul Taylor Gilead has posted data on 53 severe COVID-19 patients who received remdesivir on a compassionate use basis. More than two-thirds of the patients improved after receiving remdesivir, although the lack of a control arm makes it hard to tell what role the antiviral played in their recoveries. read more By Nick Paul Taylor AstraZeneca and the University of Oxford are set to share “positive news” on their COVID-19 vaccine soon, according to a leading U.K. journalist. The update, which could come as soon as tomorrow, may shed light on how the front-runner vaccine fared in early clinical trials. read more By Amirah Al Idrus The first data are in for Regeneron’s COVID-19 antibody cocktail—and they’re encouraging. The top dose of the treatment lowered virus levels and relieved symptoms more quickly than placebo in patients infected with COVID-19 but not sick enough to be hospitalized. read more By Amirah Al Idrus As seen in 45 younger adults, the middle dose of Moderna’s COVID-19 vaccine triggered the production of neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19, in 10 patients aged 56 to 70 and 10 patients over 71. The patients’ antibody levels were two to three times higher than those seen in patients who recovered from the disease. read more By Nick Paul Taylor A phase 1 trial of Moderna’s COVID-19 vaccine candidate has begun enrolling subjects at the highest dose. Moderna shared the update on the COVID-19 study alongside news that people in another trial had anti-Zika antibodies after receiving the biotech’s vaccine against that virus. read more By Ben Adams Daniel Menichella started the month as CureVac CEO, one of the privileged few to discuss the coronavirus response with the U.S. president and kick-starting a vaccine trial against COVID-19. read more By Amirah Al Idrus The World Health Organization accidentally revealed data from a study in China showing that the treatment neither improved patients’ condition nor tamped down on the amount of virus in their blood, the Financial Times reported, calling the trial a “flop.” But was it really a flop? read more By Beth Snyder Bulik Comirnaty. It’s a name we’ll all know soon. The new brand for Pfizer and BioNTech's COVID-19 vaccine, Comirnaty mashes up community, immunity, mRNA and COVID—pretty much everything that could fit into the moniker for the world's most high-profile product at the moment. read more By Conor Hale In a typical year, I'd compile our annual roundup of top stories while searching for images of gold confetti and festive ribbons. This year? Not so much. read more Resources 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: ZS Learn how Aerie fueled their product launches with advanced analytics. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Thermo Fisher Scientific Lack of resources to move from lab concept to the manufacture/delivery of GMP clinical supplies to patients, key milestones can be missed. Sponsored by: Cytiva Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand. 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: BioAnalytix Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics. 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: 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: Lonza Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives. 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 Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. 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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