| Today's Big NewsJan 20, 2023 |
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Register for the virtual Bionano Symposium 2023 and learn how optical genome mapping (OGM) can outperform traditional cytogenetic methods so you can easily screen cell lines for genomic instability and off-target events. 
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| By Annie Burky Microsoft announced a jarring pivot this week by firing 10,000 employees and moving resources toward artificial intelligence. Paige, the only company FDA-approved for a clinical AI application in digital pathology, is one of such enterprises touting recent partnerships with the tech giant. |
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By Ben Adams The nonprofit public health advocacy group the Physicians Committee has issued a formal complaint over allegations that Novo Nordisk paid for a promotional segment on "60 Minutes" and dressed it up as a news segment without clearly stating the drug’s risks. |
By Annalee Armstrong Eli Lilly’s bid for an accelerated approval of Alzheimer’s disease drug donanemab has been shut down by the FDA. |
By Andrea Park A JAMA investigation found that devices were much more likely to be slapped with a Class I recall if their FDA authorizations were based on devices that had previously been recalled as well. |
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Thursday, December 15, 2022 |2:00pm ET / 11:00am PT This talk emphasizes the role of partnerships between early- and late-stream analytical assay developers while tackling unique challenges in validating flow cytometric methods for Chimeric Antigen Receptor (CAR) T cells, during manufacturing and clinical monitoring. We will be introducing Critical Quality Attributes and key considerations when designing sample preparation methods, optimization, validation, and implementation for cell and gene therapy bioanalytics. Register now. 
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By Paige Minemyer UnitedHealthcare is rolling out a new virtual behavioral health coaching program backed by Optum. |
By Fraiser Kansteiner Lies, shredded documents and a trashcan dowsed in acid: Intas Pharmaceuticals’ new write-up from the U.S. FDA is a textbook example of what not to do when investigators come knocking. |
By James Waldron Back in the summer, Cyteir Therapeutics announced that it was pressing pause on plans to get one of its cancer meds into the clinic. But it’s only now that we’re seeing the fallout of the decision to focus on its lead ovarian cancer asset—in the form of laying off 70% of its workforce. |
By Robert King A new analysis from Avalere found that some Medicare Part D beneficiaries could still face affordability challenges even after taking into account a redesigned drug benefit taking effect. |
By Conor Hale The acquisition of AcuFocus includes its lens replacement implant designed to offer an extended depth of field. |
By Zoey Becker Ipsen's Onivyde proved its worth in previously untreated pancreatic ductal adenocarcinoma, a notoriously tough-to-treat cancer type. The treatment improved progression-free survival by a median of 7.4 months compared with standard of care. |
By Nick Paul Taylor The FDA has handed a boost to Astellas Pharma’s stuttering push into gene therapy by lifting the clinical hold on a phase 1/2 study in late-onset Pompe disease. Astellas was forced to pump the brakes on the AT845 program last year after a participant developed peripheral sensory neuropathy. |
By Sharon Klahr Coey Citing the “trust gap” as one of the greatest challenges in global health today, Sanofi announced its new NextGen Scholarship program a global initiative aimed at getting more people from underrepresented communities, specifically Black and ethnic minority groups, women, people with disabilities and LGBTQ+ communities, into the healthcare profession. |
By Helen Floersh Surgically removing a tumor can cure a patient, but if there are any cancerous cells left around the edges, it’s likely to return. Applying a gel containing CAR-T cells to the surgical wound could clear out residual cancer and prevent recurrence, a new mouse study found. |
By Andrea Park Fresh off the release of clinical data showing its Tumor Treating Fields technology helped improve survival rates for lung cancer patients compared to standard therapies alone, Novocure is bracing for that trial win to kick off a period of rapid growth. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we take you inside Fierce's JPM Week event. Listen in on snippets from a lively panel discussion on how companies will navigate the drug pricing policies the Biden administration rolled out just last year. And hear from Christine Roth, head of Bayer's oncology strategic business unit, about the company's plans to become a strong competitor in cancer. |
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Tuesday, January 24, 2023 | 11am ET / 8am PT Your CRO is a finalist in a project bid and clinical supplies are one of the aspects that you will manage on behalf of the client via a partner. Register now. 
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Whitepaper RCTs 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 |
Whitepaper This paper explores how Medical Affairs is adapting medical communications to meet the demands of a new environment (part 5 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences |
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 |
Executive Summary Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more. Sponsored by: Catalent |
Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 |
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 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 |
| May 1-3, 2023 | Jersey City, NJ |
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