Rare Disease on Payer’s Minds - Even with the COVID-19 emergency measures, payers still had an eye on the potential flood of gene therapies for rare diseases brewing in the pipeline, and were pondering new ways to pay for them. 
U.S. Food and Drug Administration staff reviewers on Friday said Moderna Inc.’s COVID-19 vaccine appears safe and effective for use in children aged 6 months to 17 years old as a committee of scientists will meet next week to vote on whether to recommend the regulator authorize the vaccine in children.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new and updated results from the Phase 2 CAPTIVATE study evaluating IMBRUVICA® (ibrutinib) in combination with venetoclax (I+V) as a potential fixed-duration (FD) treatment in adult patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Updated data from the FD cohort with three years of follow-up shows that I+V continues to demonstrate deep and durable responses and clinically meaningful progression-free survival (PFS) and overall survival (OS) in the first-line treatment setting.
GSK aims to get the company’s respiratory syncytial virus (RSV) vaccine to regulators for review later this year, after interim data showed the vaccine was effective in a keenly watched late-stage study involving older adults.
Diabetes may increase the risk of long COVID, new analyses of seven previous studies suggest. Researchers have also found that babies born to mothers who had COVID-19 while pregnant may be at higher than average risk for problems with brain development involved in learning, focusing, remembering, and developing social skills.
Pre-orders of vaccines for children under age five have been slow, but Biden administration senior officials say they are not alarmed and expect the pace to pick up after federal approvals later this month.
The annual meeting of the American Headache Society (AHS) is being held in Denver, Colorado from June 9-12. Here’s a look at just some of the wide-ranging research being presented.
A look at some of the latest COVID-19 news includes the U.S. Food and Drug Administration’s plans to review changes to Novavax’s manufacturing process before the regulatory agency authorizes the company’s vaccine. Moderna expects to submit data to regulators soon with expectations of the company’s bivalent COVID-19 vaccine—consisting of the original Spikevax vaccine and a newer version, mRNA-1273.214 that contains an Omicron-specific vaccine—becoming available in late summer.
It’s game day for bluebird bio. The company, battered by layoffs and cash concerns, faces a two-day crucible as the U.S. Food and Drug Administration’s Cell, Tissue and Gene Therapies Advisory Committee will give two lentiviral vector gene therapies a thumbs up or down.
The World Health Organization said on Thursday its latest investigation into the origins of COVID-19 was inconclusive, largely because data from China is missing, another blow to the WHO’s years-long effort to determine how the pandemic began.
A team involving researchers from Alcediag, Montpellier University Hospital, Les Toises Psychiatry Centre in Lausanne and Professor David J. Kupfer from the University of Pittsburgh identified and validated a combination of blood biomarkers specific to bipolar disorder. These results, recently published in the leading scientific journal Nature, have led to the development of the first diagnostic blood test for this disorder that affects more than 60 million people worldwide.