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Cancer is an incredibly intricate disease. In recent years, there’s been a shift in how early-phase oncology studies are conducted as adaptive trial designs have become more common. These designs aim to increase the chance of trial success. Read our blog to learn more. Premier Research. Built for Biotech℠
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Today's Big NewsFeb 21, 2023 |
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March 14-15, 2023 | San Francisco, CA Be in the room with the life sciences industry leaders to forge new connections & take advantage of in-person networking opportunities. Find out who you can connect with!
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| By Nick Paul Taylor Pfizer is ready to ram home its advantage in the respiratory syncytial virus maternal vaccine race. With onetime close rival GSK still stalled, the Big Pharma has put itself on course to receive a landmark approval by August and go on to challenge AstraZeneca and Sanofi’s long-acting antibody for the market. |
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By Max Bayer Staffing constraints at the FDA are throwing a wrench into Akebia's formal appeals process of its kidney disease med, vadadustat. The company appealed the agency's rejection of the med in October 2022 after it was knocked down earlier in the year. |
By Phil Taylor Thousands of studies are registered each year in the U.S. alone, so there is always a vast array of disappointing results to choose from as we compile our 10 top clinical trial flops. |
Sponsored by Ocugen Ocugen remains diligent in developing innovative COVID-19 vaccine options—including a non-mRNA injectable and next-gen inhaled vaccine—to meet the current need and prepare for an annual booster strategy. |
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April 3 - 4, 2023 | San Diego, CA The only west coast event exclusively for life science communicators to share best practices, benchmarks, and tools, as well as network with peers. Register by March 10th for the best Rate!
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By Nick Paul Taylor Astellas’ bid to bring menopause drug candidate fezolinetant to market has hit a last-minute snag. Just days before the approval decision date, the FDA has extended the review by three months to give it more time to complete its assessment. |
By James Waldron While hemophilia has soaked up clinical attention and investor dollars for decades, it’s come at the expense of a range of intriguingly named but less well-known blood clotting disorders. That’s where Hemab Therapeutics comes in. |
By Nick Paul Taylor Bridge Biotherapeutics is keeping the faith after seeing its lead inflammation candidate fail a midphase trial. BBT-401 performed numerically worse than placebo in the ulcerative colitis clinical trial, but Bridge continues to see the Pellino-1 inhibitor as an important asset and is plotting formulation changes. |
By Helen Floersh There’s no shortage of applications for RNA technology, from vaccines to treating wrinkles. Now, researchers are looking to add another indication to the list: preeclampsia, a common but dangerous condition in pregnancy where malformed blood vessels to the placenta prevent proper blood flow between the mother and the fetus, jeopardizing the health of both. |
By Annalee Armstrong,Gabrielle Masson,Max Bayer We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech. |
By Helen Floersh Scientists may have found a way to intervene on some aspects of Robinow syndrome disorders before they have a chance to fully develop. |
By Angus Liu The FDA has accepted Alnylam’s application for Onpattro in the rare heart disease of ATTR-CM, a blockbuster territory that Pfizer dominates. The bad news? There will an advisory committee meeting to examine the drug’s controversial data. |
By Andrea Park A year after Charles River Laboratories teamed up with artificial intelligence developer Valo Health to build an AI-powered drug discovery and development platform, the contract research organization is putting that tech to work. |
By Frank Diamond No generally agreed upon best practice guidelines for the treatment and diagnosis of long COVID exist. There do exist, however, guidelines for most of the symptoms that patients who may be suffering from long COVID present with. Can’t providers just take them on one at a time? |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss the intense patent fight between Moderna and Pfizer-BioNTech around the mRNA technology used in their COVID-19 vaccines. We also talk about negotiating vaccine contracts via text messages, one of the biggest medtech deals of the year and other top headlines from this week. |
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| ResearchLike many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials. Sponsored by: H1 |
| Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
| WhitepaperThis paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
| WhitepaperExploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
| WhitepaperLearn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
| On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
| WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
| WhitepaperExplore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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