| Today's Big NewsDec 19, 2022 |
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Jan 11, 2023 | 2:00pm ET Recent advances in natural language processing (NLP) caused an explosion of practical use cases that have now become viable. This webinar for healthcare & life sciences leaders surveys common NLP applications that are being widely deployed, including real world data extraction from pathology & radiology reports, patient risk adjustment & HCC coding, and more. Register now. 
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| By Fraiser Kansteiner Atara Biotherapeutics' allogeneic Epstein-Barr virus-positive (EBV) T-cell therapy tabelecleucel snagged a world-first approval in Europe, assuming the commercial moniker Ebvallo. |
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By Annalee Armstrong Fierce Biotech recounts the biggest biotech blunders and one refreshing reparation in the 2022 edition of Rotten Tomatoes. |
By Heather Landi Despite the market downturn and investor caution amid an unstable market, there are health tech companies bucking the trend and raising significant amounts of cash. Nearly two dozen healthcare-focused startups crossed the $1 billion valuation threshold to become "unicorns" in 2022. Fierce Healthcare took a look at this year's new crop of unicorns and pared down the list to the top 10 based on reported valuations. |
By Andrea Park As the EU’s new system for regulating medical devices takes effect, some medtech companies are finding the process of securing new authorizations for their previously authorized devices overwhelming—and, in some cases, not worth the hassle. |
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Tuesday, January 24, 2023 | 11am ET / 8am PT UGTs are the most common enzymes involved in metabolism after CYP enzymes, followed by numerous hydrolases, carbonyl reductases, aldehyde oxidase and other enzymes. Hear Dr. Brian Ogilvie discuss case studies and strategies to address non-CYP related metabolism questions in your drug’s safety assessment. Register now. 
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By Frank Diamond In what the Department of Justice is calling one of the biggest healthcare fraud schemes ever, a federal grand jury convicted the owner of a genetic testing lab for cancer of bilking Medicare out of hundreds of millions of dollars. |
By Max Bayer Bluebird is continuing to build on its regulatory momentum, rebooting an adolescent trial of its sickle cell gene therapy after the FDA lifted a yearlong hold. The company is planning to ask regulators to approve the treatment's use in adults in the first quarter of 2023. |
By Fraiser Kansteiner It’s been nearly a year since Novo Nordisk revealed a supply shortfall for its obesity blockbuster-to-be Wegovy. Now, it appears history is repeating for the company’s chief rival, Eli Lilly. |
By Conor Hale After decades of jokes (and legitimate complaints) that doctors’ handwriting can be largely inscrutable, Google has decided the easiest way to fix the problem is to train a computer to read those illegible prescription notes for you. |
By James Waldron The tricky indication of nonalcoholic steatohepatitis has confounded many a biotech, but Madrigal Pharmaceuticals and its investors think the company is finally onto a winner with its second positive phase 3 readout. |
By Fraiser Kansteiner Novartis is cutting 285 jobs across three New Jersey sites, according to a local Worker Adjustment and Retraining Notification Act notice. |
By Paige Minemyer Centene expects to bring in revenue of between $137.4 billion and $139.4 billion next year, the company announced at its investor day on Friday. |
By Conor Hale The company, previously known as MastOR, secured its first 510(k) clearance from the FDA for its Maestro surgical system, and shortly followed that up with the announcement that it had completed its first-in-human study of the hardware. |
By Kevin Dunleavy The FDA has blessed Eagle Pharmaceuticals' Pemfexy with a fifth indication, this one as a combo treatment alongside Merck’s Keytruda and platinum chemotherapy for those with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. |
By Andrea Park Someday in the future, migraine relief could be just a click away. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we discuss the medtech industry’s highest paid CEOs. Plus, we cover Theranos' COO's prison sentence, highlights from the American Society of Hematology annual meeting and other top headlines from this week. |
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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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Webinar Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Presented by: Twist Bioscience |
Executive Summary Strategies to help scale-up for commercial manufacturing are critical to getting cell and gene therapies to patients as more advanced therapies reach late-stage clinical studies and regulatory decisions. 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 |
Whitepaper Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Biologics |
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 |
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 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 |
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