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Wednesday, January 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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Today's Big NewsJan 6, 2023 |
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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 Fraiser Kansteiner Friday, the U.S. Food and Drug Administration signed off on the accelerated approval of the Eisai and Biogen's antibody lecanemab in Alzheimer's disease, where it will now carry the commercial moniker Leqembi. Meanwhile, the partners are taking a cautious, "phased approach" to the launch, Eisai's U.S. CEO Ivan Cheung said in an interview. |
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By Heather Landi Drugstore chain Walgreens posted a quarterly net loss of $3.7 billion Thursday as it took a $6.5 billion opioid litigation charge, sending its shares down 7% this morning. But the company raised its sales outlook driven by strong performance in its growing U.S. healthcare segment. The healthcare business brought in first-quarter sales of $989 million, up from $51 million a year ago. |
By Annalee Armstrong Karuna Therapeutics is gearing up for a potential launch of schizophrenia med KarXT—one which analysts say could be “amongst the highest in profile in recent times.” But they’ll now be doing it without their Chief Commercial Officer Charmaine Lykins, who quietly departed Thursday afternoon. |
By Conor Hale The Mount Sinai spinout raised $16 million to continue developing its test that looks for environmental exposures trapped within a piece of hair. |
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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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By Ben Adams Less than a week into 2023, and we already have a biotech name change as PsiOxus Therapeutics becomes Akamis Bio. |
By Angus Liu While Novo Nordisk, AstraZeneca and Eli Lilly are set to lead their pharma peers with the most top-line growth this year, Merck & Co. and Sanofi are notably absent from the projection despite major expected contributions from their star meds, a new Evaluate report shows. |
By Nick Paul Taylor Pfizer is stepping back from early-stage rare disease R&D. After reviewing its portfolio, the Big Pharma has begun “exploring externalization opportunities for a number of highly innovative, niche programs” as part of a rethink of its approach to orphan indications. |
By Conor Hale The move follows a string of major medtechs in the past year pushing their internal business units to take flight as separate companies. |
By Annie Burky CommonSpirit Health reported back in October that a ransomware attack had compromised the protected health information of more than 623,700 people. |
By Kevin Dunleavy With a pediatric approval in June for its next-generation pneumococcal vaccine, Merck leads a high-stakes race with Pfizer to capture the competition’s key demographic. But Pfizer is quickly gaining ground with its next-gen shot that offers more protection. Friday, the FDA designated Prevnar 20 for priority review in children aged 6 weeks through 17 years. |
By Annalee Armstrong CureVac and GSK have picked the mRNA approach that will advance in the clinic for flu and COVID-19 after seeing phase 1 data on a handful of candidates. While analysts were happy to see the win, they were skeptical of the lack of updated variant data and limited population read-out—even going so far as to call the disclosure “half-baked.” |
By Andrea Park Medical devicemakers in the European market are one step closer to securing a bit of breathing room after saying new regulatory laws could lead to product shortages among their businesses. |
By Frank Diamond In-person care for mental health services crashed in the first year of the COVID-19 pandemic. However, that gap was more than made up for in a 16- to 20-fold increase in the use of telehealth, according to RAND researchers. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we discuss the biotech industry’s rotten tomatoes. Plus, we cover the drug approvals of last year, a congressional report on Biogen's "inappropriate" communications with the FDA and other top headlines from this week. |
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Wednesday, January 25, 2023 | 1:00pm ET In this webinar, you’ll learn about a case study pursued in collaboration with Geneos Therapeutics and Personalis to utilize a tumor-informed ctDNA assay to retrospectively analyze clinical response to a class of personalized immunotherapies developed against tumor-specific neoantigens in advanced hepatocellular cancer (HCC) patients. Register now. 
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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 |
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 |
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 |
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 |
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