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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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Today's Big NewsDec 20, 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 Max Bayer Gilead-owned Kite Pharma is buying Carl June-founded Tmunity, significantly widening its CAR-T-focused expertise. The deal gives the Yescarta maker access to a range of potential cell therapy technologies developed by University of Pennsylvania researchers. |
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By James Waldron Entrada Therapeutics has been dragged back to Earth thanks to a clinical hold placed by the FDA on its Duchenne muscular dystrophy program. |
By Annalee Armstrong Cerevel Therapeutics investors themselves had some raised blood pressure as they anxiously awaited phase 1 safety results for the biotech’s schizophrenia drug. With the news that it does not, in fact, raise blood pressure, an analyst from Mizuho Securities is hoping the rest of the Pfizer apprentice’s pipeline can shine. |
Sponsored by Allucent We discuss how small and mid-sized biotechs can succeed at the start of their first clinical trials. We go in-depth about biotech industry innovation and how companies are bringing value to the industry currently, and how they can add value if they aren’t already. |
By James Waldron You have to admire Otonomy’s perseverance. The biotech has experienced a series of clinical failures throughout a gruelling year but kept the faith in its ear disorder pipeline. |
By James Waldron REGiMMUNE’s lead candidate to prevent graft-versus-host disease after stem cell transplants has passed its phase 2 test, setting the Taiwan-based biotech up for a late-stage showdown. |
By Max Bayer The FDA's accelerated approval pathway could be in for an overhaul, with new reforms included in the latest congressional spending bill. |
By Helen Floersh The scientists behind the discovery showed that it counteracted methamphetamine, too, and found that it was capable of binding to many other drugs of abuse. |
By Robert King Congress released a major omnibus package that includes a slew of healthcare policies, including partial relief to physicians from several Medicare cuts. |
By Angus Liu Despite five years of collective experience making and selling engineered human cell products, CAR-T companies are still having trouble ensuring smooth and timely access. For this report, Fierce Pharma talked to cell therapy leaders at three top cancer centers to understand how recent CAR-T launches are progressing in the real world. |
By Andrea Park A trio of Johnson & Johnson subsidiaries have filed suit against a handful of former employees and their current company, accusing the workers of stealing tens of thousands of J&J documents. |
By Dave Muoio The federal watchdog's audit of 148 Medicare bad debt claims from 2016 to 2018 found 22 instances in which reimbursement should have been denied. OIG called on HHS to provide additional, specific guidance to Medicare administrative contractors on when to review these claims. |
By Kevin Dunleavy With Eisai on the verge of a scoring a potential approval for its Biogen-partnered Alzheimer’s disease drug lecanemab, the Japanese pharma is thinking big. On Monday, Eisai inked a deal to unload one of its smaller potatoes, epilepsy drug Fycompa. Catalyst Pharmaceuticals will pick up its rights in the U.S. for $160 million upfront, with milestone and royalty payments tied to its future success. |
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 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 |
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 |
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 |
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