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Trinity Life Sciences can partner with you to assess, benchmark, plan and implement. LET’S GO. 
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Today's Big NewsMay 18, 2023 |
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Learn how modern software development is driving the future of clinical research and technology, specifically how it is impacting the next generation of IRT. Learn more. 
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| By Annalee Armstrong Former Immunomedics CFO Usama Malik has pleaded guilty to a charge of insider trading for tipping off his girlfriend that the biotech’s breast cancer drug had succeeded in a clinical trial, allowing her time to purchase shares before the information went public. |
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By Andrea Park To rev up its cell therapy engine, AstraZeneca is looking to the aptly named Revvity. |
By Helen Floersh The song of Siren Biotechnology, a brand-new startup that’s merging immunotherapy and gene therapy to treat brain and eye cancers, called to the American Society for Gene and Cell Therapy crowd. |
Sponsored by Bridge Bank Venture debt is a type of debt financing obtained by early and growth-stage companies and typically used as a complementary method to equity financing. |
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Tuesday, May 23, 2023 | 12pm ET / 9am PT Join us for this insightful webinar to explore why analytical development is often underestimated, and should go hand-in-hand with process development when addressing clinical and commercial manufacturing requirements, advantages of using integrated analytical services within the areas of process development and technology transfer, and more. Register now. 
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By Max Bayer Mustang Bio is shelving a handful of cell therapy programs and halting work on a gene therapy to treat "bubble boy disease" in order to funnel cash toward a lead asset. The company is also selling off its manufacturing facility that opened five years ago. |
Sponsored by Cytel Developing a new life-saving drug or medical device is fraught with challenges. But while challenges often vary from program to program, one in particular is guaranteed: uncertainty. In this article, Dr Kim, CMO at Cytel, discusses the nature and consequences of the uncertainty challenge, as well as the options available to help pharmaceutical and biotechnology companies navigate it. |
By Nick Paul Taylor PTC Therapeutics’ phase 3 clinical trial in the rare inherited disorder phenylketonuria has met its primary endpoint. And yet, the design of the study means analysts remain unsure about the strength of PTC’s hand and whether it can rival BioMarin’s Kuvan and live up to its $400 million peak sales forecast. |
By Nick Paul Taylor Synthego has prevailed in its intellectual property dispute with Agilent Technologies. The row led to the invalidation of two Agilent patents related to guide RNA, leading Synthego to hail the ruling as a victory “for the entire CRISPR-enabled research and therapeutics field.” |
By Angus Liu,Kevin Dunleavy In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning. |
By Andrea Park With a fresh injection of venture funding and a high-profile addition to its board, Moon Surgical is entering a new phase. |
By Fraiser Kansteiner Viatris' proposed generic of J&J’s Invega Trinza would "induce infringement” of a patent dubbed '693, New Jersey federal Judge Evelyn Padin wrote in court documents this week. Viatris’ attempts to show the patent is invalid have fallen flat, Padin continued. |
By Dave Muoio In a new filing, a coalition of unions alleged that UPMC's rapid growth and market power has allowed it to limit wages, increase workloads and keep workers from changing employers. |
By Sharon Klahr Coey Bayer Pharmaceuticals is using a not so subtle approach in showing how women can take control of heavy menstrual bleeding (HMB) in its new campaign "Seeing Red" for IUD Mirena. In addition to the original indication of contraception, Mirena is the first IUD approved by the FDA to control HMB, also known as menorrhagia, which is not just an annoyance but a medical condition. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we're launching a mini-series on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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Whitepaper ChatGPT 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 |
Whitepaper Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties. Sponsored by: Twist Bioscience |
eBook Discover 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 |
Whitepaper This 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 |
Research Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
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 |
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 |
| July 18-19, 2023 | Jersey City, NJ |
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