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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 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 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. |
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By James Waldron After signing a collaboration with fellow French company Innate Pharma in 2016 to develop natural killer cell engagers, Sanofi is paying 25 million euros upfront for a second order. |
By Annalee Armstrong Fierce Biotech recounts the biggest biotech blunders and one refreshing reparation in the 2022 edition of Rotten Tomatoes. |
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 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 Gabrielle Masson Pfizer, looking to be the king in respiratory syncytial virus vaccines and therapeutics, is going back to scoop up one therapy that was left on the table earlier this summer when the pharma giant acquired ReViral and its RSV portfolio. |
By Annalee Armstrong “Very clear, unequivocal and unprecedented” is how Zymeworks CEO Kenneth Galbraith heralded results from a mid-phase study of biliary tract cancer drug zanidatamab, which sent shares soaring nearly 30%. |
By James Waldron Three days after appointing its next CEO, Bionomics had to break the news to investors that its lead asset has flunked a phase 2 trial in acute social anxiety disorder. |
By Max Bayer Alnylam has elected to cull three clinical-stage programs, including an IgA nephropathy med once partnered with Regeneron that was headed for a phase 3 trial. Alnylam said that Regeneron pulled out of the program, prompting a reassessment of development plans. |
By Helen Floersh Scientists have found that a "master regulator" receptor of digestive processes is present on both intestinal cells and on a set of inflammatory molecules that drive IBD. A drug that stimulates it reversed inflammation-driven changes to the gut lining in mouse models of the disease. |
By Joseph Keenan With the latest in a string of acquisitions, Velocity Clinical Research is laying claim to the title of largest dedicated research site organization in the world. |
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 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 Jacqueline Renfrow Like other advertising channels, this year had its fair share of COVID vaccine-related television commercials. Companies such as Pfizer and BioNTech spent large amounts of TV dollars on campaigns highlighting “getting back to normal,” featuring loved ones reuniting after years apart. |
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 Sharon Klahr Coey When it comes to pharma’s reputation at the end of 2022, there’s some good news and some bad news. The bad news is that according to the Harris Poll, pharma’s rep in the U.S. is continuing to drop from its peak in of 62% positive in December 2020 when the first COVID mRNA shots were authorized by the FDA. But it’s not all doom and gloom for the industry, at a 45% positive rating it’s still up from a pre-pandemic 32%, so that’s good. |
Fierce podcastsDon'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 |
| 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 |
| WhitepaperLearn 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 |
| 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 |
| 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 |
| 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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