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Pneumonia is a lung infection that can be caused by viruses, bacteria or fungi and can result in millions of hospitalizations and deaths annually. Thus, to address drug-resistant infections, pharma and biotech companies are developing novel treatments such as bacteriophage therapies, immunomodulators and monoclonal antibodies.
In the fight against multidrug-resistant bacteria, scientists in Sweden have developed a new kind of antibiotic-free protection for wounds that kills drug-resistant bacteria and induces the body’s own immuneresponses to fight infections.
When developing a clinical development program for these increasingly popular therapies, it is important that sponsors use modeling and pharmacokinetic (PK) analysis to evaluate parameters that can be measured while dosing with gene therapy drugs, to characterize exposure-response data and inform rational dosing.
Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. Both next-gen shots offer enhanced protection against bacteria that can cause pneumonia, blood infections and meningitis.
The treatment has been granted US FDA breakthrough therapy designation and orphan drug designation, and has also completed a phase 3 clinical study. The biotech is eligible to receive a further $125 million if the FDA approves the drug and could receive another $225 million in commercial milestones. difficile infection (CDI).
The US Food and Drug Administration (FDA) has green-lighted the first pneumonia vaccine specifically designed for adults 50 years of age and older. According to a November 2023 readout, Capvaxive also elicited superior immuneresponses for ten of the 11 serotypes not covered by Prevnar 20.
Clinical Data Supporting Approval Demonstrated Non-Inferior ImmuneResponses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior ImmuneResponses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.
While infectious disease experts and drug companies have rightfully spent the last 18 months developing therapeutics and vaccines targeting SARS-CoV-2 and COVID-19, another global threat to public health — antimicrobial resistance (AMR) — has, and will continue to, persist until similar direct action is taken.
“Antibody responses are not likely to be the sole determinant of someone’s outcome,” said Scott Boyd, associate professor of pathology at Stanford. Some of these patients mount a vigorous immuneresponse, and others have a more moderate response. There are also other branches of the immune system involved.
SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic designed to activate the STING pathway in the tumor microenvironment in order to upregulate the patient’s immuneresponse. CAMBRIDGE, Mass. , Sokolovska, A.,
Immuneresponses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. among adults 65 years of age or older.
Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan. FDA in July 2017.
It may be caused by the immune system being triggered by a virus or bacteria that results in an atypical immuneresponse, or genetics play a role in disease development as it is more common in people whose immediate family members have Crohn’s disease.
Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. They’ll use software that searches available drugs, as well as drug-like compounds.
Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. “We NEW YORK–(BUSINESS WIRE)– Pfizer Inc.
Developing a highly effective vaccine against malaria has been technically challenging because malaria has a large and complex genome, and it’s why it’s generally more difficult to develop a vaccine against parasites than smaller viruses and bacteria.
TB is caused by the bacillus Mycobacterium tuberculosis and is transmitted when infected individuals expel bacteria into the air (e.g., In light of World TB day on March 24, the field hopes to overcome some major barriers to the drug development landscape. by coughing). million new cases reported worldwide.
Fabhalta works by inhibiting factor B, a key enzyme in the alternative complement pathway, thus calming the damaging immuneresponse. Due to a risk of serious infections from encapsulated bacteria, its use is limited to a Risk Evaluation and Mitigation Strategy requiring specific vaccinations.
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