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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 24, 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 Nektar Therapeutics’ hopes of rebuilding its battered business around lupus lie in tatters. The key phase 2 clinical trial of rezpegaldesleukin missed its primary endpoint, prompting partner Eli Lilly to drop plans for further development in lupus and reassess its next steps in atopic dermatitis. |
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By Nick Paul Taylor Novartis is nixing a nonalcoholic steatohepatitis candidate amid a narrowing of its therapeutic focus, walking away from a Pliant Therapeutics program it paid $50 million for back in 2019. |
By James Waldron Having drastically reduced head count and sold off one of two remaining assets, ObsEva has now turned its sights on the company’s U.S.-based leadership as a way of clawing back some more savings. |
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 Annalee Armstrong Destiny Pharma could be in line for $570 million thanks to a new co-development agreement with U.S.-based Sebela Pharmaceuticals for a C. difficile treatment. |
By Annalee Armstrong Fulcrum Therapeutics’ sickle cell disease therapy has been placed on a clinical hold by the FDA, capping off a tough week for drug development for the condition that saw three separate treatments discontinued. |
By Max Bayer Sangamo has elected to shelve later-stage development of its sickle cell asset, saying that it would look to find a partner for future phase 3 development. The company joins two rivals that similarly announced scaling back sickle cell plans in the last day. |
By Joseph Keenan Medidata, a branch of Dassault Systèmes, made two big changes in its senior leadership ranks. The company named a new chief executive and a chief operating officer to lead the trial tech firm. |
By Ben Adams Bristol Myers Squibb, Boehringer Ingelheim and Roche are the most mature pharmas on social media, though there are still areas in which the companies can do better. |
By Andrea Park Spinal cord stimulators were first approved to treat chronic pain in 1989, but in more recent years, researchers have begun studying the technology’s potential to address other conditions including those affecting movement. |
By Teresa Carey This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week. |
By Max Bayer,Gabrielle Masson Former Roivant Founder Vivek Ramaswamy announced a formal run this week for the White House, becoming the third Republican candidate to enter the field. As a part of the decision, Ramaswamy departed from Roivant’s board. |
By Angus Liu Eisai's Alzheimer's disease drug Leqembi won't get any special Medicare coverage—for now. AstraZeneca signed a deal worth up to $1.1 billion for a Chinese antibody-drug conjugate. Plus more. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the 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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