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May 1 - 3, 2023 | Jersey City, NJ Connect on current challenges and opportunities found within your medical affairs role to become better equipped in developing a unified scientific voice.
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| By Gabrielle Masson Nothing good lasts forever, a sentiment that held true for private biotech financing in 2022. After two record-setting years, fundraises finally fell, dipping 24% from the highs of 2021. |
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By Zoey Becker In a slight decrease from 2021, Amgen's M&A-hungry CEO Robert Bradway collected $21.4 million in total pay last year. |
By Annalee Armstrong Some 300 biotech executives and industry leaders are objecting to the decision from a Texas federal judge to block the FDA’s approval of the abortion drug mifepristone. The executives argue that the judicial interference will undermine the agency’s authority and endanger innovation in the industry. |
By Annalee Armstrong A cell has to know what it is to do its job. New research from Trinity College Dublin has helped reveal just how cells establish their identities, which could have implications for developing more targeted cancer treatments. |
By Zoey Becker After a round of layoffs last year, Biogen is axing positions once again. This time, the company is reportedly targeting employees on its multiple sclerosis team. |
By Kevin Dunleavy Four months after filing for bankruptcy, Clovis Oncology has found a buyer for its assets including the rights to ovarian cancer drug Rubraca. Pharma& Schweiz GmbH of Switzerland submitted the highest bid at an auction on March 30. The agreement is for $70 million up front, with an additional $50 million on achieving regulatory milestones and $15 million in sales-related milestones. |
By Andrea Park Elizabeth Holmes must report to prison at the end of this month as previously scheduled, the judge in her case ruled this week, shutting down the disgraced Theranos founder’s bid to delay her sentence while she appeals her conviction. |
By Andrea Park In a classic “two steps forward, one step back” situation, just as Philips is aiming to wrap up the repair-and-replace program for the 5.5 million respiratory devices it began recalling two years ago, the company has had to re-recall a slew of the already repaired machines. |
By Angus Liu AbbVie and J&J are pulling two Imbruvica accelerated approvals after failing to satisfy the FDA. They're doing so even though the drug met its primary endpoint in a confirmatory trial in one of the indications. |
By Nick Paul Taylor Genentech has published the findings of its investigation into an alleged fraud and a cover-up involving a 2009 Nature paper co-authored by Marc Tessier-Lavigne. None of the 35 current and former employees interviewed for the probe reported knowing of fraud, but the process did leave unanswered questions. |
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. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we talk about biotech’s top money raisers in 2022. We also cover J&J's talc litigation, prison plans for Elizabeth Holmes and more of this week's top headlines. |
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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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Whitepaper Accelerated approval pathways create an additional layer of complexity in the chaotic oncology marketplace, leaving manufacturers of all sizes seeking a new commercialization model for launch success. Sponsored by: EVERSANA |
Whitepaper The preclinical hematotoxicity screening method that helps clients eliminate bad players earlier in the drug development process Sponsored by: ReachBio | The Cell Biology Experts™ |
Whitepaper We’ve identified four must-have tools to manage today’s scientific information chaos. How many are you utilizing? Sponsored By: CCC |
Research The current real-world safety reporting process is too burdensome for most HCPs – how can technology help? Sponsored by: Veradigm |
Whitepaper How advanced medicines commercial readiness differs and the resources needed to maximize potential. Sponsored by: Herspiegel Consulting |
Whitepaper This 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 |
Whitepaper Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
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 |
| May 1-3, 2023 | Jersey City, NJ |
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