Featured Story | By Nick Paul Taylor The CEOs of all the leading Western developers of COVID-19 vaccines have vowed to only file for FDA approval after demonstrating safety and efficacy in phase 3. The pledge comes amid reports that the Trump Administration is pushing for a vaccine to be approved before the November election. read more |
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Top Stories By Nick Paul Taylor Aveo Oncology has regained the full global rights to ficlatuzumab. Biodesix was co-developing the hepatocyte growth factor inhibitory antibody with Aveo but has chosen to exercise its opt-out right before the program moves into phase 3. read more By Nick Paul Taylor Merck has presented detailed phase 3 data on P2X3 receptor antagonist gefapixant. Across the two late-phase trials, the higher dose of the drug triggered improvements in several measures of chronic cough symptoms but also caused adverse events that drove a significant minority of patients to drop out of the study. read more By Ben Adams Fierce 15 winner Prelude Therapeutics is going for a $100 million IPO, a pretty common goal for biotechs in 2020, as it looks to finish off early clinical work for its cancer candidate PRT543. read more By Ben Adams Sanofi’s trials and attempts at getting new drugs and vaccines against the pandemic onto the market have been some of the hardest hit by COVID-19. read more By Amirah Al Idrus There is no shortage of biotech startups working to streamline drug discovery, but those efforts are concentrated at the earliest stages of drug discovery and sooner or later, all drug developers run into the same bottleneck: preclinical testing. Manifold Bio is developing protein barcoding technology to solve this problem. read more By Conor Hale A study from Google and epidemiology researchers at Oxford University found that digital contract tracing using a network of smartphones could potentially help stem the spread of the novel coronavirus, even if a relatively small number of people download the app. read more By Amirah Al Idrus Astronauts on the International Space Station work out two hours a day to fend off the bone and muscle loss that happens outside the pull of Earth’s gravity. But what if a drug could replace that exercise? A group of musclebound mice might hold the answer. read more |  | De-risk Your Drug Pipeline with Organs-on-Chips Technology Drug-induced liver injury is a leading cause of drug candidate attrition. Our Liver-Chip enables more predictive preclinical insights than conventional 2D cell culture by incorporating primary cells in a more physiologically-relevant microenvironment, helping you de-risk drug candidates before the clinic. Learn more. |
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. Sponsored by: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment Sponsored by: LexisNexis Risk Solutions Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information. Download the whitepaper by Optum to see how novel data platforms can uncover hidden insights on medication adherence helping life sciences companies maximize product utilization. Sponsored by: Oracle Health Sciences Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual." 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: 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. | 
