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Dengue poses a year-round risk in many parts of the world, with outbreaks occurring frequently. As of July 2024, the United States has reported travel-related and locally acquired cases of dengue fever. This indicates the U.S. is quietly joining the over 100 countries currently facing outbreaks.
As of July 5, 2024, the U.S. Centers for Disease Control and Prevention (CDC) has reported 2,391 dengue cases in 45 jurisdictions.
The unfortunate leader reporting mosquito-transmitted disease is the state of Florida.
Florida Health's latest weekly vector-borne illness report confirmed that ten locally acquired dengue cases were reported from four counties (Miami-Dade (6), Monroe (2), Pasco, and Tampa) in 2024.
In 2023, 186 humans were reported from five Florida counties to have locally contracted dengue.
Additionally, 244 travel-associated dengue cases were reported, mainly by visitors from Brazil and Cuba. In 2023, Florida Health reported 609 travel-associated dengue cases.
While most disease outbreaks of this nature have a variety of preventive vaccines and treatments available, dengue is an anomaly.
The CDC's Health Advisory, dated June 25, 2024, stated, 'No antiviral medications are approved to treat dengue. Treatment is supportive and requires careful volume management.'
"Maintain a high suspicion for dengue among patients with fever and recent travel (within 14 days before illness onset) to areas with frequent or continuous dengue transmission.'
'Healthcare providers should consider locally acquired dengue among patients with signs and symptoms highly compatible with dengue (e.g., fever, thrombocytopenia, leukopenia, aches, pains, rash) in areas with competent mosquito vectors.'
Also, in late June 2024, the CDC informed its vaccine committee that U.S. residents do not currently have access to a previously approved dengue vaccine.
Furthermore, the CDC did not clarify if the second-generation Qdenga® vaccine would be authorized in 2024.
GSK plc recently announced a restructuring of its collaboration agreement with CureVac N.V. Under the new agreement, GSK will focus on the development of mRNA vaccines for influenza and COVID-19 while withdrawing from other infectious disease projects.
As part of the revised contract reported on July 3, 2024, GSK will pay CureVac €400 million (approx. $430 million) upfront. Additionally, GSK has committed to providing up to $1.13 billion in development, regulatory, and sales milestone payments and offering tiered royalties.
Tony Wood, GSK's chief scientific officer, said in a press release, “We are excited about our flu/COVID-19 programs and the opportunity to develop best-in-class mRNA vaccines to change the standard of care. With this new agreement, we will apply GSK’s capabilities, partnerships, and intellectual property to CureVac’s technology to deliver these promising vaccines at a pace.”
This new deal will replace all previous financial terms from the original agreement. In exchange for these payments, GSK will secure full global rights to develop and commercialize CureVac’s investigational mRNA vaccines for influenza and COVID-19, including combination formulations.
Currently, the partners have seasonal flu and COVID-19 shots in Phase II development and an avian flu candidate in Phase I. Both companies believe that these candidates have best-in-class potential.
Completion of the new agreement remains subject to certain antitrust and regulatory approvals and customary closing conditions. The original collaboration between CureVac and GSK was initiated in July 2020.
CureVac is a multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine.
The U.S. National Institutes of Health (NIH) recently announced a Phase 1 trial testing the safety of an experimental nasal vaccine may provide enhanced breadth of protection against emerging variants of the SARS-CoV-2 coronavirus is now enrolling healthy adults at three sites in the United States.
Announced on July 1, 2024, the NIH is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in pre-clinical studies by scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases.
The investigational vaccine, MPV/S-2P, uses murine pneumonia virus (MPV) as a vector to deliver a version of the SARS-CoV-2 spike protein (S-2P) stabilized in its prefusion conformation. MPV has aan affinity for epithelial cells that line the respiratory tract and may be effective in delivering vaccines to the places where natural coronavirus infections begin.
NIAID Director Jeanne M. Marrazzo, M.D., M.P.H., commented in a press release, “While first-generation COVID-19 vaccines continue to be effective at preventing severe illness, hospitalizations, and death, they are less successful at preventing infection and milder forms of disease."
"With the continual emergence of new virus variants, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission.”
This is the first NIAID clinical trial to be conducted as part of the U.S. Department of Health and Human Services Project NextGen. More information about the trial is available at clinicaltrials.gov using the identifier NCT06441968.
For the 2024-2025 season, the U.S. CDC has recommended updated COVID-19 vaccines.
Note - Link correction was completed on July 4, 2024.
The global search for innovative urinary tract infection (UTI) treatments recently received a $10 million boost.
Recce Pharmaceuticals Limited, a leading Australian developer of a new class of Synthetic Anti-Infectives, announced it had received binding commitments to raise about $10 million in new funds.
On July 2, 2024, Recce confirmed that the funds raised from the Placement will be used to advance clinical trials for intravenous use of R327 and topical applications of R327G, including Registrational Phase III clinical activities in Indonesia, Investigational New Drug (IND) enabling activities, working capital, and offer costs.
In a press release, Chief Executive Officer James Graham commented on the capital raising: "We are" delighted with the support of our capital raising from our existing shareholders and welcome new institutional shareholders to our register. We thank NorthStar Impact Fund for taking the time to understand Recce and the positive impact we aim to achieve."
Recce stated the Company will be fully funded through to FY2026 to fund significant IND-enabling clinical trials in Australia, covering intravenous and topical treatments for UTI/Urosepsis and ABSSSI, including Diabetic Foot Infections, as well as U.S. Department of Defence Burn Wound Program, Continued development of a pre-clinical portfolio, manufacturing expansion and provides the necessary capital to see Indonesian clinical trials for topical treatments through to commercialization.
On July 1, 2024, Recce clarified the Phase I/II clinical trial is an Open Label, Adaptive Design Evaluation, Crossover Study of the Safety, Pharmacokinetics and Pharmacodynamics of Various RECCE® 327 (R327) Intravenous Dose and Infusion Rates.
The primary trial outcomes were to evaluate the safety and tolerability of R327 administered at various infusion rates ranging from 15 to 45 minutes in healthy male and female participants, and to assess the plasma pharmacokinetics of R327 using the same infusion rates.
The secondary trial outcomes focused on evaluating the concentration of R327 in urine at various doses and infusion rates and examining the ex vivo pharmacodynamics, specifically the minimum inhibitory concentration, of urine and blood samples from participants. Trial outcomes were successfully achieved.
An independent data review has been conducted, and the positive safety and efficacy conclusions stated in the announcement released on June 28, 2024. A comprehensive data review will be conducted, with results to be made available to the Company, which are expected to align with findings to date.
In the United States, And in the United States, Pivya™ (pivmecillinam) recently gained the Food and Drug Administration (FDA) approval for treating adult women with uncomplicated UTIs. Pivya's availability in the U.S. is forecasted for 2025.
Voices of Alzheimer's, a national advocacy organization led by people living with Alzheimer's disease, today announced it celebrates the U.S. Food and Drug Administration's (FDA) decision to grant traditional approval of donanemab (Kisunla) for treating early Alzheimer's disease.
Following last year's first-ever traditional approval of a drug to slow the progression of Alzheimer's, today's decision builds on that progress by providing patients, care partners, and providers with another alternative to care during the early stages of the disease.
While Kisunla is not a cure, new treatment options still bring tremendous hope to affected families and offer priceless additional time for people in the early stages of Alzheimer's disease.
Jim Taylor, President & CEO of Voices of Alzheimer's and husband to Geri, who was diagnosed with Alzheimer's in 2012, said in a press release on July 2, 2024, "Today is a day for celebration in the Alzheimer's community. When doctors diagnosed my wife Geri with Alzheimer's, there was not a single approved treatment to slow the progression of the disease."
"Now, a decade later, we have two traditionally approved disease-modifying treatments and further advancements in the pipeline."
Taylor continued, "I am also encouraged by the evidence supporting stopping treatment with Kisunla when amyloid plaques are removed."
"People living with Alzheimer's and their care partners already face significant costs and burdens in their day-to-day lives. The possibility of stopping treatment could translate to lower costs and a reduced treatment burden."
In light of this news, Voices of Alzheimer's reiterates our call for the Centers for Medicare and Medicaid Services to remove coverage with evidence development requirements for the entire class of monoclonal antibody treatments for Alzheimer's.
The total cost of Kisunla will vary by patient based on when they complete treatment, says Eli Lilly.
Lilly Support Services for Kisunla is a free support program committed to helping patients navigate treatment with Kisunla. The program includes coverage determination assistance, care coordination, nurse navigator support, customized support, and resources. For more information, visit www.Kisunla.Lilly.com or call 1-800-LillyRx (1-800-545-5979).
Alzheimer's disease preventive vaccine candidates continue to be researched in clinical trials.
Despite the World Health Organization declaring an end to the recent pandemic about a year ago, COVID-19 remains a significant health risk for immunocompromised patients.
To address this unmet need, AstraZeneca today announced its Marketing Authorisation Application for sipavibart (AZD3152), an investigational long-acting monoclonal antibody, has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA) for preventing COVID-19 in immunocompromised patients.
This passive immunization is essential for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.
Prof. Paul Loubet, M.D., Ph.D., MPH, Professor of infectious diseases, University of Montpellier, head of the Infectious and Tropical Diseases Department, Nîmes University Hospital, France, and SUPERNOVA clinical trial investigator, said in a press release on July 1, 2024, “The disease burden of COVID-19 remains high for immunocompromised patients who are disproportionately impacted compared to the general population, despite vaccination."
"With cases expected to rise in the winter months, adding more pressure to stretched healthcare systems, sipavibart has the potential to be an important option for immunocompromised patients who remain at risk, and it has demonstrated COVID-19 protection in a mixed variant environment.”
In addition to the EMA, AstraZeneca is in dialogue with other regulatory authorities on potential authorization or approval pathways for sipavibart.
