| Today's Big NewsMay 10, 2023 |
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Choosing the best eCOA platform that considers the needs of patients, site staff and data requirements are all critical factors. But it takes more to reach success. Download your eCOA Technology Guide.
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| By Annalee Armstrong An FDA committee will consider whether evidence supports the benefits and risks of Sarepta's DMD gene therapy on Friday. The agency seems unconvinced. |
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By Nick Paul Taylor Boehringer Ingelheim has teased the obesity data that emboldened it to start gearing up for phase 3. Recipients of the Zealand Pharma-partnered prospect lost up to 14.9% of their weight after 46 weeks, but the data released so far make it hard to say how Boehringer compares to Eli Lilly and Novo Nordisk. |
By James Waldron Bayer has taken its radiopharmaceutical pipeline up a gear, paying out $45 million upfront to Bicycle Therapeutics on a collaboration spanning multiple oncology targets. |
Sponsored by ValGenesis Inc. Cell and gene therapies hold great promise but can also carry serious risks. Applying a risk-based approach during development and manufacturing increases patient safety and product quality. Read more. |
By Gabrielle Masson All the rumors are true. After months of sale speculation, Syneos Health has officially been snapped up by three private investment firm affiliates for the eye-watering sum of $7.1 billion. |
Sponsored by Precision for Medicine Discover Sofia Baig's vision for clinical research, data-driven insights & patient centricity at Precision for Medicine! |
By Max Bayer Reata and Kyowa Kirin are taking the cleaver the bardoxolone ending development of the kidney disease treatment after more than 13 years of work. The decision was simultaneous to new phase 3 data showing the med did not improve the time to end-stage renal disease compared to placebo. |
By Nick Paul Taylor Gossamer Bio is going all in on seralutinib, laying off 25% of its staff and stopping work on all other candidates to free up money for a phase 3 trial of its pulmonary arterial hypertension prospect. |
By Max Bayer FibroGen is taking on Fortis Therapeutics' sole asset, an antibody-drug conjugate for prostate cancer and multiple myeloma, to fortify a pipeline that has to date been mainly siloed toward anemia and fibrotic diseases. |
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 Andrea Park Genomic sequencing can help match cancer patients to the most effective treatments based on their specific genetic makeup—but only if they have access to the necessary testing. Thermo Fisher Scientific and Pfizer, which have joined forces to expand the global reach of next-generation sequencing technologies. |
By Nick Paul Taylor The U.S. has a new most reputable pharma company: Horizon Therapeutics. In a survey (PDF) of U.S. patient groups, Horizon was the only company to keep its position in the top three, with Roche and Servier rising to displace ViiV Healthcare and Pfizer from the other two spots on the leaderboard. |
By Andrea Park Only a few years after Siemens Healthineers put down $1.1 billion to pick up Corindus and its robotic-assisted endovascular surgery system, the medtech giant is tightening the technology’s scope. |
By Kevin Dunleavy Idorsia’s insomnia treatment Quviviq will be tested in post-traumatic stress disorder patients in a DOD-sponsored phase 2 study. The trial will also measure the effectiveness of two antidepressant drugs as remedies for the disorder. |
Fierce podcastsDon't miss an episode |
| This week on "Podnosis," we discuss the rise of digital therapeutics and remaining barriers to implementation. We also talk about what it takes to fix the PBM industry. |
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July 18-19, 2023 | Jersey City, NJ Our speaking faculty features leaders from big pharma, small-mid size pharma, biotechs, and more. Save $500 when you. Register Today!
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WhitepaperChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations. Sponsored by: Elucidata Corp., Cloud SAAS in Life Sciences R&D |
eBookDiscover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success. Sponsored by: EvidentIQ |
Research What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
WhitepaperThis paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing. Sponsored by: Blue Matter, strategic consultants in the life sciences |
ResearchStrategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
Whitepaper How can eConsent provide a more flexible approach to informed consent? Sponsored by: YPrime |
Whitepaper Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
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 |
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 |
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