News
An inspection of a facility making Elevar’s rivoceranib uncovered deficiencies, leading the FDA to reject a combination therapy that includes the drug. The rebuff is the third strike for the partners after the agency issued manufacturing-related denials for the other drug in the combo.
FEATURED STORIES
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
On Wednesday, the CDC’s Advisory Committee on Immunization Practices voted to recommend Valneva’s chikungunya virus vaccine Ixchiq for certain high-risk patient groups.
This episode explores the drug pricing gap between consumer experience and industry norms. Join Lori and our KOLs as we explore the drivers of healthcare costs, the CBO, rebates, and overall spend in this new series.
Stakeholders Hope Bill Will Create IRA Drug Negotiation Parity Between Biologics and Small Molecules
Congressional legislation seeks to “equalize” the negotiating period between biologics and small molecules under the Inflation Reduction Act’s Drug Price Negotiation Program.
Electronic consent can personalize the patient experience in clinical trials and even improve retention. At Medable, where I am CSO, we’re committed to driving the adoption of this transformative technology.
Under the research and development agreement announced Wednesday, Viatris is securing global rights to Idorsia’s late-stage heart and lupus candidates.
The vaccine maker’s fourth-quarter revenue and earnings on Wednesday missed Wall Street expectations, while providing full-year 2024 sales guidance of flat to lower than last year.
Plus, last week Richard Gonzalez announced his retirement from AbbVie, PhRMA appointed Gilead’s O’Day to chair its board and Joseph Papa became president and CEO of Emergent.
AbbVie continued its dealmaking spree Wednesday by partnering with OSE Immunotherapeutics to develop its early-stage, first-in-class antibody for chronic and severe inflammation.
This week Lori, Greg and Tyler discuss AbbVie: how longtime CEO Richard Gonzalez navigated Humira’s LOE, his victorious retirement announcement, and the future of biosimilars.
The Canadian biotech’s regulatory setbacks continued on Tuesday with an FDA Refusal to File letter for its intramuscular formulation of the humanized monoclonal antibody Trogarzo.