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The U.S. Centers for Disease Control and Prevention (CDC) today reported that in Alaska, nirsevimab (Beyfortus™) was 89% effective in preventing RSV-associated hospitalization for infants in their first RSV season and 76% and 88% effective against medically attended illness for children in their first and second seasons, respectively.
On November 14, 2024, the CDC's MMWR 73(45);1015–1021 stated these findings support current CDC recommendations for all infants in their first RSV season to either receive nirsevimab or be protected through maternal vaccination and for children entering their second season with increased risk for severe RSV illness, including all AI/AN children, to receive nirsevimab.
According to the manufacturer, 50mg and 100mg of Beyfortus injection doses will be available for the 2024-2025 RSV season. And supply is secured for 20 countries.
Tonix Pharmaceuticals Holding Corp. today announced the publication of a paper entitled, “Recombinant Chimeric Horsepox Virus (TNX-801) is Attenuated Relative to Vaccinia Virus Strains in Both In Vitro and In Vivo Models.”
Data published in the peer-reviewed journal mSphere demonstrate that TNX‐801 is less virulent than 20th-century vaccinia vaccines in immune-compromised mice.
The publication describes data in which TNX-801 was compared with older vaccinia vaccine strains used to eradicate smallpox for tolerability in both in vitro and in vivo models.
Together, TNX-801 was shown to be more than 10—to 1,000-fold more attenuated (or less virulent) than the older vaccinia smallpox vaccines.
Combined with the ability of TNX-801 to protect animals against lethal challenge with Clade Ia mpox virus, the Company believes that the new tolerability data support the idea that TNX-801 is a candidate vaccine to control the ongoing mpox Clade Ib and mpox Clade IIb outbreaks.
Previously, single-dose vaccination with TNX-801 was shown to protect animals from a lethal challenge with Clade Ia mpox.
The new Clade Ib mpox is spreading among children in Africa and, so far, has been carried by adult travelers from Africa into non-African countries.
The global mpox outbreak from Clade IIb, which commenced in May 2022, continues in various countries, including the United States.
“Addressing the new Clade Ib mpox outbreak and the ongoing spread of Clade IIb mpox may require a single dose mpox vaccine that provides durable protection,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, in a press release on November 13, 2024.
The current standard of prevention focuses on Bavarian Nordic's JYNNEOS® (MVA-BN®, IMVAMUNE®, IMVANEX®) two-dose vaccine, which is commercially available in the United States.
AC Immune SA today announced positive interim safety and immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, its anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of patients with early Parkinson's disease (PD).
ACI-7104.056 is an optimized formulation of its clinically validated anti-a-syn predecessor active immunotherapy. It generated a target-specific antibody response against pathological oligomeric a-syn to inhibit spreading and downstream neurodegeneration in early PD.
The accumulation of alpha-synuclein protein aggregates has been shown to cause inflammatory stress in cells and contribute to the degeneration of neurons in the brain.
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented in a press release on November 14, 2024, "We are encouraged by these initial Phase 2 safety and immunogenicity data on our ACI-7104.056 active immunotherapy being studied in early PD.'
"The level of immunogenicity after only 3 months of treatment, as well as the continued positive safety profile, reinforces the best-in-class characteristics of our clinically validated anti-a-syn active immunotherapy for treating PD."
"We look forward to sharing further updates in H1 2025, including the decision to expand into Part 2 of the VacSYn study."
The U.S. NIH says Parkinson's is a progressive movement disorder of the nervous system. It causes nerve cells (neurons) in parts of the brain to weaken, become damaged, and die, leading to symptoms that include problems with movement, tremors, stiffness, and impaired balance. People with PD may have difficulty walking, talking, or completing other simple tasks as symptoms progress.
The recently released World Health Organization (WHO) 2024 Global Tuberculosis Report revealed tuberculosis remains a leading infectious disease globally.
Unfortunately, the WHO African Region continues to be significantly impacted by tuberculosis (TB) outbreaks.
For example, Nigeria and the Democratic Republic of Congo (DRC) are among the eight countries that account for over 60% of the people estimated to have developed TB in 2023.
Nigeria has 4.6% of the global new cases, while the DRC has 3.1%.
When visiting Nigeria or the DRC, the U.S. CDC's Travel Health Notices do not recommend TB vaccination.
The only vaccine use to prevent TB is about 100 years.
Today, over ten versions of the Bacillus Calmette-Guérin (BCG) vaccine are used worldwide.
Over the decades, BCG vaccination has been found effective for children but less so for adults. The good news is that various TB vaccine candidates are in late-stage development, with authorizations expected soon.
The Texas Department of State Health Services (DSHS) reports an increase in pertussis cases in 2024, with about triple the number of cases reported this year compared with the same period in 2023.
Texas has confirmed 772 pertussis cases in 2024, compared to 264 last year.
This DSHS announcement on November 12, 2024, follows a national trend, which has seen a more than fivefold increase in 2024 cases based on preliminary data posted by the U.S. CDC.
As of week #44, reported on November 2, 2024, CDC data show that more than five times (22,240) as many pertussis cases were reported compared to (4,209) at the same time in 2023.
According to a state-based analysis, Pennsylvania reported about 10% (2,462) of all pertussis cases in 2024.
Pertussis is a highly contagious illness caused by the bacteria Bordetella pertussis and is vaccine-preventable, says the CDC.
Early symptoms are very similar to the common cold. People may develop paroxysms (coughing fits) one to two weeks after the first symptoms start. The cough generally gets worse and becomes more common as the illness continues. It can cause people to vomit or make a “whoop” sound when breathing in.
DSHS advises clinicians to follow the recommendations below and report any cases to their local health department within one workday.
Novavax, Inc. today announced its financial results and operational highlights for the third quarter ended September 30, 2024. A few highlights are inserted below:
For the third quarter of 2024, total revenue was $85 million, compared to $187 million in the same period in 2023. And ended the quarter with $1 billion in cash and receivables.
Advanced preparation for Sanofi to assume lead commercial responsibility of Nuvaxovid™ COVID-19 vaccine for the 2025-2026 vaccination season in the U.S., Europe, and select major markets not currently subject to Novavax Advanced Purchase Agreements or existing partnership agreements.
Entered the U.S. market with an improved Nuvaxovid presentation and broader access, available in pre-filled syringes in over 30,000 locations across major pharmacy retailers and regional grocers.
John C. Jacobs, President and Chief Executive Officer of Novavax, commented in a press release on November 12, 2024, “In addition to progress on our other value drivers, this past quarter, we made significant progress defining our R&D strategy as we look to expand beyond COVID-19 and influenza."
"We intend to develop our early-stage pipeline with a disciplined approach, as we focus on areas where our technology can have a positive impact on public health and generate value.”
An example is the R21/Matrix-M™ vaccine that includes Novavax's proprietary saponin-based Matrix-M adjuvant. This malaria vaccine is manufactured by the Serum Institute of India Private Ltd and is available in various African countries in 2024.
ImmunityBio, Inc. today announced its financial results for the third quarter ended September 30, 2024. The company achieved a net product revenue of approximately $6 million during the three months ended September 30, 2024, surpassing net product revenue of $1 million in the prior quarter and analyst estimates.
ANKTIVA® (N-803), U.S. FDA-approved and commercially available since May 2024, is now widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare). ImmunityBio has secured coverage for over 200 million medical lives through medical reimbursement policies.
ANKTIVA is a cytokine interleukin-15 (IL-15) that plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells.
By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity, resulting in a prolonged duration of complete response.
“The U.S. launch of ANKTIVA for non-muscle-invasive bladder cancer (NMIBC) CIS continues to gain momentum, and we are pleased to see the clinical impact for patients,” said Richard Adcock, President and CEO of ImmunityBio, in a press release on November 12, 2024.
“The Centers for Medicare and Medicaid Services have issued our permanent J-code, effective January 1, 2025."
"Our submission of ANKTIVA for NMIBC CIS to the U.K.'s MHRA for potential approval demonstrates our plans for global expansion. Further, we anticipate an EU submission this quarter.”
Arcturus Therapeutics Holdings Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study Can Proceed” notification for the Company’s Investigational New Drug application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to enhance the expression of haemagglutinin and neuraminidase antigens, thereby enabling lower doses than conventional mRNA vaccines.
“Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic with our STARR® self-amplifying mRNA technology is a key step in this important process,” said Joseph Payne, President & CEO of Arcturus Therapeutics, in a press release on November 11, 2024.
“The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza.”
The clinical study is funded by the U.S. Biomedical Advanced Research and Development Authority.
The U.S. and European vaccine agencies have previously approved avian and pandemic influenza vaccines and have recently awarded funding grants for (bird flu) vaccine candidates.
