| Today's Big NewsApr 12, 2023 |
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July 18-19, 2023 | Jersey City, NJ Hear the latest industry trends from leaders in the field, and developed with input from our esteemed advisory board, to ensure you have a sound plan for your company, brands, and yourself. Save $500 when you Register Today!
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| By Annalee Armstrong The biopharmas that objected to a Texas judge’s ruling suspending the approval of the abortion drug mifepristone are not content with just a letter. The companies have now banded together to support the U.S. government’s appeal in an amicus brief. |
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By Conor Hale Icahn previously put forward three names that he wants to see appointed to the DNA giant’s nine-seat board of directors. Now he says that—if anyone needs to go to make room—it might as well be the CEO. |
By Angus Liu Astellas is doing some house cleaning under new CEO Naoki Okamura, booking impairments from three programs before its full-year earnings report. |
By Nick Paul Taylor The evidence that drug-induced liver injury is a classwide problem for BTK inhibitors is mounting up. In the wake of its partial clinical holds on studies involving Biogen and Sanofi, the FDA has clamped down on trials of Merck KGaA’s contender in response to evidence of damage to the liver of two patients. |
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Thursday, April 20, 2023 | 11am ET / 8am PT In this presentation, we highlight key study design challenges and considerations for rare disease CGT trials and discuss the potential for leveraging in silico approaches for generating synthetic control arms that enable a control-based comparative assessment of efficacy. Register now.
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By Fraiser Kansteiner After decades under Johnson & Johnson, a massive plant that once cranked out over-the-counter mainstays like Pepcid and Imodium is poised to hit the market. |
By Andrea Park Novo Nordisk’s diabetes treatments have so far revolved around injected insulins and other medications along with a slate of insulin pen technologies to help perform those injections. Now, however, the Big Pharma is looking even deeper under the skin for its next diabetes therapeutic. |
By Nick Paul Taylor Junshi Biosciences has established its credentials as the next challenger for the increasingly congested Chinese PARP inhibitor market. A phase 3 trial of the candidate hit its primary endpoint, setting Junshi up to compete with products including AstraZeneca and Merck & Co.’s Lynparza for the ovarian cancer space. |
By Zoey Becker As Arbutus tries its hand in lawsuits against Moderna and Pfizer, an appeals court upheld a prior decision to strike one of its patents. |
By Conor Hale A study of miniaturized, leadless pacemakers found that, due to their smaller size, they could provide a promising, short-term option for certain children with abnormally slow heartbeats. |
By James Waldron Employees at Aeglea BioTherapeutics who survived the company’s previous two rounds of layoffs may be left wondering if it was worth it, as the biotech effectively throws in the towel in response to the latest data from one of its two remaining rare disease candidates. |
By Kevin Dunleavy Five months after merging, manufacturers Kindeva Drug Delivery and Meridian Medical Technologies are expanding their capabilities in Missouri. In a $100 million investment over four years, Meridian plans to convert its newly purchased building in Bridgeton to increase production of drug-device combination products with added fill-finish capability. |
Fierce podcastsDon't miss an episode |
| | This week on "Podnosis," we discuss Medicaid redeterminations and the long-term outlook for the misunderstood program. We also talk about colorectal cancer and what stakeholders can do to tackle this disease. |
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| Thursday, May 4, 2023 | 11am ET / 8am PT Join industry experts for this insightful webinar to learn more about enzyme inhibition studies. We’ll explore how these studies drive informed decisions for drug developers, frequently asked questions from sponsors, recommendations for achieving successful regulatory submission, and more. Register now. |
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| WhitepaperThe preclinical hematotoxicity screening method that helps clients eliminate bad players earlier in the drug development process Sponsored by: ReachBio | The Cell Biology Experts™ |
| WhitepaperWe’ve identified four must-have tools to manage today’s scientific information chaos. How many are you utilizing? Sponsored By: CCC |
| WhitepaperHow advanced medicines commercial readiness differs and the resources needed to maximize potential. Sponsored by: Herspiegel Consulting |
| WhitepaperThis paper outlines an approach that digital health / therapeutics companies can use when developing a go-to-market strategy for the complex US market. Presented by Blue Matter, strategic consultants in the life sciences |
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| Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. 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 |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
| 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 |
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