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While typically required for a product’s marketing approval, in some situations conducting a randomized controlled trial is unethical or impractical. Often in these scenarios, the solution is to use an in silico method to construct a virtual patient control arm. Download our guide to learn how in silico approaches can be used to evaluate drug candidates before clinical trials or in single-arm clinical trials.
Premier Consulting. Built for Biotech℠ 
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Today's Big NewsFeb 14, 2023 |
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Learnings from three IQVIA case studies. Accelerate your trials with these strategies: contract execution to go-live in 3 months, 50% timeline reduction in study build and 95% patient compliance. On-Demand Now. 
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| By Nick Paul Taylor GSK is trimming its ties to Vir Biotechnology, walking away from COVID-19 antibody and vaccine research projects while continuing to collaborate on two pandemic assets and programs against other respiratory diseases. |
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By Gabrielle Masson Several biotech entrepreneurs have launched a new venture capital vehicle dubbed Curie.bio that will serve not only as a seed investor, but as a drug discovery co-pilot for founders. |
By Nick Paul Taylor,Gabrielle Masson Sanofi's head of global R&D John Reed, M.D., Ph.D., has departed for a spot at Johnson & Johnson, where he'll serve as executive vice president of pharmaceutical R&D. |
By Max Bayer Pharnext is moving on from developing an Alzheimer's treatment, saying further development would cost too much. The move underscores how much cash runway is being emphasized at a time of tighter fundraising. |
By Annalee Armstrong Just in time for Valentine’s Day, Sesen Bio has made up with a group of investors who had alleged they were offered a “bribe” to support a merger with cell therapy biotech Carisma Therapeutics, clearing the way for the transaction to proceed. |
By James Waldron Despite phase 3 data last year that demonstrated the effectiveness of Soligenix’s cutaneous T-cell lymphoma treatment, the FDA has halted the biotech's approval plan in its tracks. The agency has sent a refuse-to-file letter, leaving the company scrambling to decide on a path to market and its stock sinking. |
By Max Bayer Cullinan is adding a new bispecific to its rapidly growing clinical-stage bispecific, plucking U.S. rights to the med from Harbour BioMed. The treatment is in a phase 1 trial of advanced solid tumors. |
By Helen Floersh Scientists have developed a drug called a covalent heterobivalent inhibitor that's capable of preventing peanut-specific anaphylaxis in mouse models. The drug held off anaphylaxis for at least two weeks in the mice after a single dose, without any obvious signs of toxicity. |
By Helen Floersh A pair of new studies identified and validated two potential drug targets in animal models of both genetic and sporadic ALS, paving the way for broad treatments. |
By Kevin Dunleavy Twenty-two months after European Commission President Ursula von der Leyen admitted to The New York Times that she negotiated a COVID-19 vaccine deal with Pfizer CEO Albert Bourla, Ph.D., through text messages, the newspaper is suing the commission over its refusal to make the texts public. While the lawsuit was filed on Jan. 25 and listed on the European Court of Justice’s public website on Monday, none of the documents related to the case are available to the public. Two people familiar with the suit confirmed it to Politico. |
By Andrea Park The layoffs will affect 14% of Vicarious’ workforce, CFO William Kelly told investors this week. With 165 employees listed in its most recent annual report, that means around 23 roles could be eliminated. |
By Fraiser Kansteiner A federal judge scrapped Merck and Glenmark’s bid for summary judgment in a five-year-old lawsuit that claims the drugmakers leveraged a 2010 settlement to stifle generics of Merck’s former cholesterol blockbuster Zetia. |
By Sharon Klahr Coey The wings and Rihanna’s halftime show weren’t the only things that were hot during the Super Bowl. Astellas showcased its “Heat on the Street” disease state awareness campaign for vasomotor symptoms, more commonly known as “hot flashes and night sweats,” during the Big Game. |
By Robert King Provider groups say CMS needs to go further to reform prior authorization, pressing for the agency to adopt standards for gold carding and to eliminate step therapy. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss which companies made the list of the top 10 pharma M&A deals of 2022 and what was at stake last year. We also talk about what last year's biggest deal means for M&A activity this year. |
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Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
Whitepaper This paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
Whitepaper Exploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
Whitepaper Learn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
Whitepaper RCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
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Whitepaper What 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 |
Whitepaper Explore 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 |
Whitepaper For 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 |
Whitepaper Learn 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 |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper How 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 |
Whitepaper Explore 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 |
Whitepaper Planning 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 |
| May 1-3, 2023 | Jersey City, NJ |
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