| Today's Big NewsApr 7, 2023 |
| 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 Gabrielle Masson Takeda is moving away from early R&D work in the AAV gene therapy and rare hematology spaces, with an unknown number of employees set to “transition out” of the pharma. |
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 Max Bayer,Gabrielle Masson Amarin CEO abruptly resigned after investor activists shook up the board. CinCor's former CEO jumps to Abivax after AstraZeneca sale. Page joins Arvinas to lead global oncology strategy. |
By Fraiser Kansteiner At the behest of an independent data monitoring committee, Merck and Eisai have called it quits on their phase 3 study of Keytruda plus Lenvima as an initial treatment in unresectable or metastatic melanoma. |
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 Conor Hale A group of investors says the company’s leadership has shown slow progress in clinical trials and presided over sliding stock value. |
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 Zoey Becker After a long battle, it's officially the end of the road for Covis' preterm birth med Makena. The FDA finally revoked its approval after two advisory committee recommendations to do so. |
By Zoey Becker In yet another TAF/TDF drug lawsuit for Gilead Sciences, the company faces claims from two plaintiffs that it caused injuries with its older tenofovir products while shelving a safer generation of new products. |
By Robert King New bipartisan legislation in the House aims to tie Medicare physician payments to rises in inflation to better keep pace with rising costs. |
By Teresa Carey This week on "The Top Line," we discuss how this year is chock-full of blockbuster drugs headed for the patent cliff, besides the well-known patent cliff for AbbVie's Humira. We also cover Johnson & Johnson's talc settlement offer and more of this week's top headlines. |
By Angus Liu BioNTech linked up with a Chinese company on two antibody-drug conjugates. Sanofi is reportedly looking to separate its consumer health unit in India through a de-merger. Takeda is doubling down on celiac disease with yet another deal in the area. And more. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss how this year is chock-full of blockbuster drugs headed for the patent cliff, besides the well-known patent cliff for AbbVie's Humira. We also cover Johnson & Johnson's talc settlement offer and more of this week's top headlines. |
|
|---|
|
|
| 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 |
| Whitepaper How 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 |
| 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 |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| 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 |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. 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 |
| 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 |
| 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 |
| |
|
