Featured Story | By Nick Paul Taylor Sanofi and GlaxoSmithKline have moved their adjuvanted protein-based COVID-19 vaccine into the clinic, setting them on a path they expect to lead to a filing for approval in the first half of next year. read more |
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Top Stories By Ben Adams In a reminder to the world of how hard it is to kill viruses and help those infected, Janssen has been forced to terminate its influenza A antiviral hopeful. read more By Nick Paul Taylor Johnson & Johnson’s $6.5 billion takeover of Momenta Pharmaceuticals came out of the blue last month. Yet, behind the scenes, the companies had been circling each other for more than 18 months, culminating in a drawn out due diligence process that drove Momenta to issue J&J an ultimatum. read more By Amirah Al Idrus Taysha Gene Therapies launched just four months ago, but it plans to ride the biotech wave to a $100 million IPO. It recently topped up its coffers with a $95 million series B, but, with plans to hit the clinic by the end of the year, more money can’t hurt. read more By Conor Hale After six months of treatment, Amylyx Pharmaceuticals’ AMX0035 demonstrated a significant benefit compared to placebo, delaying the fast-acting neurodegenerative disease. read more By Amirah Al Idrus Magenta Therapeutics started the year losing its chief scientific officer when Michael Cooke hopped over to IFM Therapeutics. Now, the company has picked his successor: Lisa Olson, Ph.D., who previously led immunology discovery at AbbVie. Along with Olson, Magenta also hired Kevin Johnson, Ph.D., to lead its regulatory and quality unit. read more By Angus Liu Scientists at Mayo Clinic and the University of Pennsylvania shed light on the role of a protein called poly(GR) in toxic TDP-43 aggregation, a hallmark of frontotemporal dementia and amyotrophic lateral sclerosis. They showed in mice that antisense drugs by Ionis might help counteract these neurodegenerative diseases. read more By Conor Hale Roche plans to make a rapid antigen test for the novel coronavirus widely available in Europe later this month, while also submitting it to FDA reviewers for an emergency authorization in the U.S. read more By Eric Sagonowsky Amid doubts about the FDA’s decision-making process during the pandemic, biotech CEOs on the front lines of research are laying out their approach and asking “all parties” involved in the process to adhere to high scientific standards. read more Enrollment Showcase | Presented by: Biotility Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more. |
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Resources Sponsored by: EVERSANA How independent drug launch and commercialization can lead to higher market capitalization. Sponsored by: AMRI Download our white paper to learn more about the growth trends, complex anatomy and intricacies of developing these armed antibodies, as well as AMRI’s approach to their discovery and development. Sponsored by: LexisNexis Risk Solutions Avoid severe compliance penalties by staying on top of evolving laws. Sponsored by: Quotient Sciences This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging. Download now >> Sponsored by: Clarify Health In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy. Sponsored by: Benchling Life science R&D generates a LOT of data. Learn how to make sense of it and harness its potential with this step-by-step guide. Sponsored by: Thermo Fisher Scientific Don’t oversimplify your solubility challenges. Sponsored by: Clinical Ink Download this free whitepaper to learn how to execute fast, high-quality clinical trials through eSource for studies that boost efficiency for both sponsors and sites. Sponsored by: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. 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: Thermo Fisher Scientific Download the whitepaper to learn more. 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Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: Thermo Fisher Scientific How to select the right dosage form for your Phase I clinical supply. Sponsored by: Thermo Fisher Scientific Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker. 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: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. 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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