Drug Development
Pfizer announces the first data from its Metsera-acquired pipeline just ahead of its earnings call, where analysts pressed execs for more details; Merck and Roche also released Q4 and full year earnings, with Eli Lilly, Novo Nordisk and others reporting Wednesday; REGENXBIO hits a regulatory snag ahead of its upcoming PDUFA; more.
FEATURED STORIES
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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The question before the committee was whether the benefits of teplizumab outweigh the risks as it voted 10-7 in favor of the drug to delay clinical type 1 diabetes mellitus.
Fennec is looking for a second chance to approve PEDMARK, its pediatric chemotherapy-induced hearing loss prevention drug, as it resubmits its NDA for the agent to the U.S. FDA.
Bristol Myers Squibb has been busy the last two weeks with a string of approvals, positive clinical trial updates and deals. Here’s a look.
A two-stage Phase III clinical trial by Sanofi and GSK, is studying a COVID-19 vaccine candidate targeting the original SARS-CoV-2 strain as well as the South African B.1.351 variant.
Determined to take its next-generation engineered cell therapies to the next level, BlueRock teams up with Senti Biosciences with futuristic medicines in mind.
The EUA was granted base on interim data from the Phase III COMET-ICE trial in high-risk adult outpatients.
The U.S. FDA has granted approval to MYFEMBREE, Myovant Sciences, and Pfizer’s once-daily treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Drug companies have been suggesting that booster shots will be needed. However, it is up to the CDC’s recommendation if booster shots are necessary.
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
This is the second IND to come out of the two companies’ collaboration. They will initiate a Phase I trial of the drug in cardiometabolic diseases.