WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST When paired with Gilead’s remdesivir, Eli Lilly’s Olumiant was able to knock a whole day off average recovery times for hospitalized patients facing COVID-19, according to a recent NIH study—putting the rheumatoid arthritis drug in the running to become the third FDA-authorized treatment for the disease. But at the same time, the agency cited quality control issues at Lilly’s antibody manufacturing site. Elsewhere, former FDA Commissioner Scott Gottlieb said Regeneron’s boat has sailed when it comes to meeting this year’s demand for doses of its antibody cocktail—but that production could still scale up for 2021. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Kyle Blankenship Months into the COVID-19 pandemic, just two therapies have emerged as FDA-approved emergency therapies hospitalized patients. Last month, Eli Lilly rolled out findings for rheumatoid arthritis med Olumiant in an effort to become the third—and new data shows the extent of the drug's effect on improving recovery. read more |
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Top Stories Of The Week By Ben Adams Infectious disease expert Anthony Fauci, M.D., has said of Regeneron’s experimental antibody cocktail that: “There is a reasonably good chance that in fact it made [President Donald Trump] much better.” read more By Kyle Blankenship Days removed from its star turn in President Donald Trump's COVID-19 treatment, Regeneron's antibody cocktail could be on the fast track to an emergency approval. But if it gets there, will there be enough supply to meet this year's demand? That boat's already sailed, a former FDA chief warned. read more By Amirah Al Idrus Messenger RNA (mRNA) candidates are among the front-runners in the race for a COVID-19 vaccine, with Moderna and tandem Pfizer and BioNTech planning to seek emergency approvals later this year. But vaccination is just the tip of the iceberg for mRNA technologies, which Yusuf Erkul, Ph.D., thinks could be more useful as treatments for cancer, COVID-19 and beyond. read more By Carly Helfand After Pfizer’s Ibrance failed a crucial study in HR-positive, HR-negative postsurgery breast cancer patients, the company clung to hope that it could still show a benefit in a high-risk subset of those patients. But new data have officially snuffed out those hopes. There’s “no saving adjuvant for Ibrance,” SVB Leerink analyst Geoffrey Porges wrote in a Friday note to clients. read more By Amirah Al Idrus Johnson & Johnson put its late-stage COVID-19 vaccine study on hold because a patient has fallen ill. The pause comes just weeks after the company kicked off the 60,000-patient study and about a month after AstraZeneca suspended its own COVID-19 study for similar reasons. read more By Kyle Blankenship Just days after Eli Lilly sent its COVID-19 antibody ahead for FDA scrutiny, the drugmaker's immediate chances were halted by a damaging trial stop for the therapy. Now, the FDA has knocked Lilly for its manufacturing controls at a New Jersey site handling production of the antibody. read more By Conor Hale As an increasing number of biopharmaceutical companies go all-in on artificial intelligence, Takeda has now committed to equipping each of its scientists with cloud-based research tools by the end of this decade. read more By Sharon Klahr Coey AstraZeneca wants people to know that while many aspects of daily life have stopped during the pandemic, cancer hasn’t. That's the goal of the company's “New Normal Same Cancer” awareness campaign to address the drop in cancer screenings and care during the pandemic. read more By Arlene Weintraub A Johns Hopkins team found that blocking the protein factor D prevented the process by which SARS-CoV-2 over-stimulates the immune response, causing the destruction of healthy cells in the lungs, blood vessels and organs. They believe the discovery could inspire new treatments to prevent severe COVID-19 symptoms. read more Resources Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored by: LexisNexis Risk Solutions A complete Life Science Industry Snapshot in One Report Sponsored By: ICON Clinical Research Ltd The culture of clinical research is evolving from one directed by researchers to one driven by the needs of patients and those who care for them. Sponsored By: The PerkinElmer Signals Screening Team Creating integrated HCS workflows in a single platform increases accuracy; reduces time and helps to identify the most appropriate hits or drug candidates. Learn more about a reliable method for creating a more efficient, faster, 3D image and multi-parametric data analysis workflow. 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: Cascade Chemistry, API CDMO Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success. Sponsored by: EVERSANA An integrated compliance model can be the competitive differentiator to commercialization and move the needle from cost center to value. Learn How. 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: Formedix Learn how to save time and reduce costs and complexity by streamlining the clinical trial process. Sponsored by: LabVantage Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions. Sponsored by: Thermo Fisher Scientific Learn how to safeguard supply, improve distribution and reduce program costs and risks Sponsored by: Clinical Ink Learn how the right data capture solution can prompt the patient to follow the correct procedures and automatically sort the responses, according to protocol. Sponsored by: Guidehouse While COVID-19 has shifted the rules of the healthcare industry, research shows there was already progress on changes being made for how pharma companies are launching products. Sponsored by: Blue Matter Consulting Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers. Sponsored by: Evidation Health Achieving patient centricity depends on evolving how evidence is generated. Sponsored by: 4G Clinical This white paper addresses the complexity of basket and umbrella designs, and how modern technology is critical to run flexible, agile and quality-driven trials. 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 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 Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. 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: 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. | 