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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 15, 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 Biogen has soured quickly on Bruton’s tyrosine kinase inhibitor orelabrutinib. Just 19 months after paying $125 million for ex-China rights in multiple sclerosis, the Big Biotech is punting the prospect back to InnoCare Pharma. |
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By Annalee Armstrong Biogen’s new CEO Christopher Viehbacher has wasted no time getting a pipeline re-prioritization underway while signaling that the formerly restrained company is ready to make some deals. |
By Max Bayer Arrowhead's hepatitis B program may have been left in limbo after Fierce Pharma revealed J&J is shaking up its infectious disease group, but last week the company told investors it was at least confident its NASH collab was safe. Now, it appears J&J has even turned its back on that asset. |
By James Waldron Concert Pharmaceuticals managed to keep hold of the breakthrough tag for its alopecia areata therapy, even though the approval of Eli Lilly’s rival gave the FDA second thoughts. |
By Nick Paul Taylor AlloVir has generated early evidence its lead prospect works in solid organ transplant patients, reporting phase 2 data that suggest it has a shot at expanding beyond its initial focus on stem cell transplants. |
By Gabrielle Masson,Max Bayer,Annalee Armstrong Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing. |
By Joseph Keenan Clinical trial software provider Sophia Genetics has inked a partnership with AstraZeneca to improve clinical trials for new cancer treatments. |
By Kevin Dunleavy In November, Takeda said its blood cancer drug Iclusig topped Novartis’ Gleevec in a phase 3 trial in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Three months later, at the American Society of Clinical Oncology virtual conference, Takeda is touting data indicating Iclusig has the potential to become the “standard of care” in the indication, according to the abstract’s lead author. |
By Andrea Park Not long after locking down FDA clearance for a device used to collect high-volume blood samples from the comfort of a user’s own home, Tasso is once again expanding its reach—both geographically and in terms of its product portfolio. |
By Ben Adams When COVID hit and much of the world was forced to stay in place from spring 2020, many of us were left scared and uncertain about the future. But for parents with chronically ill children, they actually felt safer during the pandemic. |
Fierce podcastsDon'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 |
| 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 |
| WhitepaperRCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
| Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
| 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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