NIH

mRNA technology helped propel the development of some of the most successful drugs in pharma history — notably, the Comirnaty COVID-19 from Pfizer/BioNTech generated almost $56 billion in 2022 while Moderna’s Spikevax vaccine raked in $18.4 billion. But demand for COVID-19 vaccines continues to cool. In 2023, Comirnaty brought in $15 billion between its two…

The FDA and NIH have debuted the Critical Path for Rare Neurodegenerative Diseases (CP-RND), a public-private partnership focused on developing new therapies for amyotrophic lateral sclerosis (ALS) and rare neurodegenerative diseases. One of the goals of the CP-RND is to foster innovation in drug discovery and development as well as clinical testing. In addition, CP-RND…

U.S. Dept. of Health and Human Services (HHS) announced that it formed a new research project agency for health. HHS Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health (NIH). Adam H. Russell was appointed as acting deputy…

The Biden-Harris administration has announced that the NIH has licensed COVID-19 research technologies and vaccine candidates to the Medicines Patent Pool (MPP). Working with the WHO’s COVID-19 Technology Access Pool (C-TAP), the NIH will provide licenses to enable manufacturers to use the technologies to develop COVID-19 vaccines, treatments and diagnostics. In total, NIH is providing…

The National Institute of Allergy and Infectious Diseases (NIAID) has announced a Phase 1 clinical study of HIV vaccines using mRNA sequences. The study will test the safety and immunogenicity of three investigational HIV mRNA vaccines known as BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA. The three HIV vaccine…

The National Institutes of Health (NIH) announced a plan to provide approximately $185 million over five years to a consortium researching genomic variation. Initiated and funded by NIH’s National Human Genome Research Institute (NHGRI), the Impact of Genomic Variation on Function (IGVF) consortium will receive the $185 million over five years in the form of…

The National Institutes of Health (NIH) has launched a study to gauge the antibody response of a third dose of mRNA COVID-19 vaccine in patients with autoimmune disease. Participants in the study had an insufficient immune response to the primary series of vaccination. The Phase 2 study will also test the impact of pausing immunosuppressive…

While the COVID-19 pandemic has highlighted the prowess of the pharmaceutical industry, it should also “serve as a major wake-up call,” said Dr. George Yancopoulos, co-founder, president and CSO of Regeneron (NSDQ:REGN), at a panel at the virtual USA India Chamber of Commerce meeting. COVID-19 has underscored the importance of preparing for infectious pandemics and…

The NIH today announced that a clinical trial is underway to study whether people who are highly allergic or have a mast cell disorder are more likely to develop an allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines. Reports of severe allergic reactions to COVID-19 vaccines have made headlines since the rollout to the…

The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial. NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned that information the company released from its AZD1222 vaccine clinical trial may be outdated.In turn, that may…

The NIH announced today that it has launched the last of three Phase 3 clinical trials to evaluate blood thinners to prevent life-threatening blood clots in adults with COVID-19. As part of the  Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, the trial will study the use of Bristol Myers Squibb/Pfizer’s Eliquis blood thinner in…

The NIH announced today that it has halted a clinical trial of COVID-19 convalescent plasma among ER patients with mild-to-moderate symptoms after the trial found no significant benefit from the treatment. An independent data and safety monitoring board (DSMB) recommended on Feb. 25 that NIH’s stop enrolling new patients. The Clinical Trial of COVID-19 Convalescent…

A segment of the population is wary of COVID-19 vaccines. One of the main reasons why is the rapid pace at which they were developed. But the mRNA vaccines FDA was able to authorize in late 2020 were years in the making, stressed Kizzmekia Corbett of the NIH at CDC’s National Forum on COVID-19 Vaccine…