| Today's Big NewsJan 18, 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 Max Bayer J&J is packing up a global phase 3 trial of its HIV vaccine after failing to prevent infections compared to placebo. The news comes a year and a half after a different regimen of the vaccine failed a separate phase 2 trial in Africa. |
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By Zoey Becker After an anti-abortion coalition sued the FDA over its 2000 approval of abortion pill Mifeprex, the agency argued that pulling the drug 23 years after its regulatory green light would "undermine the administrative framework" that Congress designated for drug regulation. |
By Robert King The number of providers serving as accountable care organizations in 2023 increased slightly as new forms meant to help spur participation take root. |
By Gabrielle Masson Wilbur Ross' SPAC and Alzheimer’s focused-Aprinoia Therapeutics have inked one of the first biotech blank check deals of the new year, reigniting hope in the chilly SPAC waters. |
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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 Andrea Park In interviews with Fierce Medtech during the J.P. Morgan Healthcare Conference in San Francisco last week, leaders from several medtech companies shared the industry trends they’re keeping an eye on in 2023 and beyond. |
By Angus Liu With a recent acquisition, Ipsen joined a growing list of drugmakers doubling down in rare diseases. Despite increasing Big Pharma investments in the area, Ipsen CEO David Loew believes his company can hold its own as a midsize player. But there's one field he doesn't want to enter just yet. |
By Gabrielle Masson After a brutal year of biotechs slashing programs and culling staff, the hottest topic at last week’s J.P. Morgan Healthcare conference was whether the frosty market is likely to thaw in 2023. But while some companies are counting every dollar, Fierce Biotech caught up with two CEOs about riding the rocky market waves and why they think their biotech is well positioned for the next few years. |
By Dave Muoio Forty-six healthcare entities with more than $10 million in liabilities filed for Chapter 11 in 2022, bringing the sector back to pre-pandemic levels after just 25 filings in 2021. |
By Andrea Park A handful of medtech companies have kicked off 2023 with workforce reductions, and now, PAVmed is joining the queue with some cost-cutting measures of its own. |
By Annie Burky Paytient snatched up $40 million in series B funds. The company adds its interest-free Visa card to the payer ecosystem. Employers, health systems and insurers pay a fee to the fintech company so patients can pay for service at the point of care and repay the cost back to Paytient through an interest-free payment plan. |
By Kevin Dunleavy A week after hiring Matt Stober to take over as CEO, Abzena has sold a new biologics drug substance facility in Sanford, North Carolina, to Pfizer for an undisclosed sum. Pfizer, which already operates a gene therapy manufacturing site in Sanford, will produce pipeline products at the new facility, which also will add capacity to make “in-line medicines," it said. |
By Gabrielle Masson Gilead is expanding with a new research center that's plotted in headquarters Foster City, California, as it races to develop 10 new transformative therapies. |
By Conor Hale After collaborating with the developer of artificial intelligence-powered medical imaging programs for just over two years, Bayer has sealed the deal to acquire Blackford Analysis. |
Fierce podcastsDon't miss an episode |
| | In this week's episode of "Podnosis," we talk about the Fierce 15 honorees. We also discuss how to prevent the disruption of cancer care in times of crisis. |
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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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| 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 |
| WhitepaperThis 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 |
| WhitepaperHow 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 |
| WhitepaperWhat 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 |
| 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 |
| 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 |
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