A day after announcing it would pump $120 million into a Michigan manufacturing facility for Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. produced new data it plans to use in an U.S. NDA submission for treating COVID-19. While some data for the oral antiviral fell short of statistical significance, other companies are not far behind Pfizer in their drive for FDA acceptance using similar approaches.
Eli Lilly and Co. crossed the line in front of three strong competitors with the U.S. FDA’s approval of Olumiant (baricitinib) as a first-in-disease systemic treatment for severe alopecia areata. Two of those three are, like Olumiant, JAK inhibitors and have recent phase III data to run by the FDA.
The EMA has a list and it’ll be checking it frequently to avoid shortages with the help of COVID-19 marketing authorization holders and EU members states.
Based on a preliminary data analysis of its second and newest COVID-19 booster candidate, Moderna Inc. said it plans to ask the U.S. FDA to approve mRNA-1273.214 ahead of potential shipping in late summer 2022. The vaccine contains mRNA-1273 (Spikevax) and a vaccine candidate targeting omicron. New phase II/III results show the candidate hitting all the study’s primary endpoints when compared to Moderna’s original vaccine, mRNA-1273.
Code Biotherapeutics Inc. has raised an upsized and oversubscribed series A financing to develop programs for treating rare and genetic diseases that include Duchenne muscular dystrophy and type 1 diabetes.
The world’s biggest cancer-focused conference began June 3 as more than 40,000 attendees are expected at the American Society of Clinical Oncology’s (ASCO) annual gathering. The conference is being held in live in Chicago and is also available virtually. Among the more than 2,500 abstract presentations in about 120 subject subcategories are potential breakthroughs in treating non-small-cell lung cancer from Immutep Ltd., Cullinan Oncology Inc. and Surface Oncology Inc. Each company has seen upticks in their stock value, some as much as 10%, during the week as the conference approached and their data are presented.
Five-year survival rates for people with metastatic colorectal cancer haven’t budged much in recent decades but new data presented at the American Society of Clinical Oncology’s annual conference pushed the boundary enough to be notable.
Building on years of informal collaboration, the American Society of Clinical Oncology (ASCO) and the World Health Organization (WHO) said they plan to measure and improve cancer care an equity gap of cancer care around the world.
Following a negative phase II/III study of an investigational treatment for major depressive disorder, Praxis Precision Medicines Inc. is dropping staff from the payroll and refocusing the company’s resources on tremor and epilepsy. The Aria study of PRAX-114, a positive allosteric modulator extrasynaptic GABA receptor, missed its primary endpoint, statistical significance as measured on the Hamilton Depression Rating Scale. It also missed the study’s secondary endpoints.
Five-year survival rates for people with metastatic colorectal cancer haven’t budged much in recent decades but new data presented at the American Society of Clinical Oncology’s annual conference pushed the boundary enough to be notable.
