| 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 Robert King Congress released a major omnibus package that includes a slew of healthcare policies, including partial relief to physicians from several Medicare cuts. |
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By Zoey Becker As the seasons change and one year turns to the next, Johnson & Johnson’s talcum powder litigation rolls on. The latest update involves an expert witness who much of the plaintiff's case hinges on. |
By Gabrielle Masson In another twist down the CytoDyn rabbit hole, former CEO Nader Pourhassan, Ph.D., and Amarex CEO Kazem Kazempour are both facing multiple charges for their alleged roles in schemes to defraud investors. |
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. |
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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 Annalee Armstrong Magenta Therapeutics has stopped dosing a group of patients after a serious adverse event was reported in a phase 1/2 trial for the biotech’s leukemia med. |
By Heather Landi DEA alleged that Truepill filled prescriptions that were unlawful by exceeding the 90-day supply limits and/or written by prescribers who did not possess the proper state licensing. |
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. |
By Andrea Park The U.K.’s Competition and Markets Authority is escalating its investigation into Cochlear’s planned acquisition of Demant subsidiary Oticon Medical, based on concerns that the merger could stanch competition in some areas of the hearing device market. |
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 Fraiser Kansteiner By expanding an existing partnership with Cypriot pharmaceutical company Medochemie, Viatris aims to boost drug manufacturing in Vietnam and improve patients’ access to locally made medicines there. Specifically, Viatris will transfer technology that Medochemie will use under license to make certain drugs from Viatris’ noncommunicable disease portfolio. |
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. |
By Andrea Park Just a few months after upgrading its portfolio of recharge-free spinal cord stimulators with FDA approval for a new version of the technology, Abbott has done the same for its line of rechargeable neurostimulation devices. |
By Gabrielle Masson ContraFect’s CEO has dubbed results from a discontinued phase 3 trial “uninterpretable," and yet the biotech is still clinging to hope that its lead candidate has potential in several indications. |
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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