News
The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad.
FEATURED STORIES
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
THE LATEST
Seladelpar, which Gilead acquired when it bought CymaBay in February for $4.3 billion, showed positive results for reducing pruritus in primary biliary cholangitis patients and reducing inflammation.
Neuroscience-focused Rapport Therapeutics and radiopharma developer Telix Pharma announced their respective plans Friday for initial public offerings on the Nasdaq for undisclosed dollar amounts.
To support its growing antibody-drug conjugate portfolio, AstraZeneca on Monday said it is investing $1.5 billion in a Singapore production site that will include all steps of the ADC manufacturing process.
The European Patent Office last week upheld one of Moderna’s key patents, handing the biotech an important victory in its protracted COVID-19 vaccine battle with Pfizer and BioNTech.
Pfizer’s Wyeth unit notched a legal victory over AstraZeneca on Friday as a federal jury found the British-Swedish company violated two key patents in developing and marketing its lung cancer drug Tagrisso.
While Eli Lilly and Novo Nordisk currently dominate the GLP-1 receptor agonist space, there are more than 50 candidates in clinical development for obesity and type 2 diabetes, according to analytics firm GlobalData.
Life science companies can protect intellectual property in multiple ways, including leveraging IP rights.
Bayer on Thursday provided additional data on late-stage studies of its rival drug to Astellas’ Veozah, which met all primary endpoints.
A European Medicines Agency panel on Friday cited a possible but unconfirmed risk of cancer and recommended that hydroxyprogesterone caproate drugs be suspended from the European Union market.
Bolstered by promising response data from its Phase II study, Amgen announced Thursday it got the FDA’s green light for its first-in-class bi-specific T-cell engager Imdelltra for extensive-stage small lung cancer.