Instituto Butantan

Global Anti-Venom Market Analysis Report 2024-2032: Increasing Investments in Developing New Drugs and Technological Innovation Fueling Growth - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 1, 2024
Health, Pharmaceutical, USD, Mortality, System, Fast Track, WHO, Fish, World Health Organization, Molecular Modeling Database, ANAVIP, Poisoning, Vaccine, Growth, Instituto Butantan, Incidence, Patient, Biting, Death, Snakebite, Therapy, Snake, NCBI, Overalls, Prevalence, Disease

The "Global Anti-Venom Market Report by Type, Animal Type, End User, Region and Company Analysis 2024-2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Anti-Venom Market Report by Type, Animal Type, End User, Region and Company Analysis 2024-2032" report has been added to ResearchAndMarkets.com's offering.
  • The growing prevalence of snake and other animal bites, such as fish stings, drives the anti-venom market.
  • The global market for anti-venom is expected to grow due to increasing investment in developing new drugs and technological innovation in treating venomous bites.
  • The anti venom market in the U.S. is expected to have significant growth due to the country's high occurrence of snake bites.

Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Monday, November 13, 2023
VLA, CEPI, Epidemic, Euronext Paris, Adolescence, Licensure, Safety, Saint-Herblain, Food, European Medicines Agency, GMT, Ageing, CHIKV, Valneva SE, Clinical trial, Vaccination, EMA, History, European, FDA, Coalition, Instituto Butantan, Geometric mean, Antibody, Food and Drug Administration, Vaccine

Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.

Key Points: 
  • Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.
  • These results complement the initial Phase 3 safety data the Company reported for the trial in August 20231.
  • The pivotal immunogenicity data showed that a single-dose vaccination with VLA1553 induced a robust immune response in adolescents aged 12 to
  • An independent Data Safety Monitoring Board has continuously evaluated safety data during the trial and has not identified any safety concerns.

Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ®

Retrieved on: 
Friday, November 10, 2023
VLA, CEPI, Webcast, LMIC, Epidemic, Disease, Euronext Paris, Health Canada, Viral, Research, Low, Saint-Herblain, Climate change, Licensure, Safety, Food, PRV, Advisory Committee, European Medicines Agency, Ageing, Valneva SE, Risk, Pan American Health Organization, Priority review, Fatigue, EMA, Patient, Climate, FDA, Vaccine, Death, Notifiable disease, ACIP, Coalition, Priority, Trial of the century, Partnership, Arthralgia, R, PAHO, Temperature, Travel, Pharmaceutical industry, Lancet, CHIKV, Instituto Butantan, Chikungunya

Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

Key Points: 
  • Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.
  • As sponsor of the first chikungunya vaccine approved in the U.S., Valneva has received a Priority Review Voucher (PRV) from the FDA, which it intends to monetize to help finance its research and development (R&D) programs.
  • With this U.S. approval, IXCHIQ® becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva1 has brought from early R&D to approval.
  • Initial safety data from this trial were included in the submission to the European Medicines Agency (EMA) in October 202313.

China Review Studio and Chinese Red Cross Foundation Release "Generation Vax" Documentary for Broadcast Internationally

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Monday, October 2, 2023
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BEIJING, Oct. 2, 2023 /PRNewswire/ -- China Review Studio, in collaboration with Chinese Red Cross Foundation recently released a documentary on YouTube named Generation Vax. Directed by internationally renowned director Mitchell Farkas, the film focuses on the theme of China's Covid-19 vaccine by deeply diving into the safety, effectiveness, and publicity of China's vaccines.

Key Points: 
  • BEIJING, Oct. 2, 2023 /PRNewswire/ -- China Review Studio, in collaboration with Chinese Red Cross Foundation recently released a documentary on YouTube named Generation Vax.
  • Directed by internationally renowned director Mitchell Farkas, the film focuses on the theme of China's Covid-19 vaccine by deeply diving into the safety, effectiveness, and publicity of China's vaccines.
  • The film also reveals the story of how clinical phase III of China's vaccine has been conducted in Brazil.
  • The second half of the film documents China's calls for the world to work together to face down public safety incidents together.

Health Canada Accepts Valneva’s Chikungunya Vaccine License Application for Review

Retrieved on: 
Tuesday, August 29, 2023
Epidemic, Priority review, NDS, Biologics license application, Pan American Health Organization, Saint-Herblain, Priority, Marketing, Coalition, European Medicines Agency, Valneva SE, CEPI, PAHO, Coalition for Epidemic Preparedness Innovations, Licensure, Chikungunya, Person, Trial of the century, Fast track (FDA), EMA, Euronext Paris, VLA, MD, Instituto Butantan, Ageing, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Vaccine, Lancet

Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

Key Points: 
  • Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.
  • This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023.
  • A Biologic License Application (BLA) is currently under priority review1 by the U.S. Food and Drug Administration (FDA)2.
  • VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need.

Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Monday, August 28, 2023
Epidemic, Biologics license application, DSMB, Saint-Herblain, Coalition, European Medicines Agency, Valneva SE, CEPI, Clinical trial, Coalition for Epidemic Preparedness Innovations, Licensure, Prescription Drug User Fee Act, EMA, Euronext Paris, Food and Drug Administration Amendments Act of 2007, VLA, Instituto Butantan, PDUFA, Adolescence, Ageing, FDA, Lancet, BLA, Food, Safety, CHIKV, Vaccine, Pharmaceutical industry, Chikungunya

Saint-Herblain (France), August 28, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.

Key Points: 
  • Saint-Herblain (France), August 28, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.
  • An independent DSMB has continuously evaluated safety data during the trial and has not identified any safety concerns.
  • Importantly, the initial data suggest a favorable safety profile in seropositive participants, confirming the observations following re-vaccination of individuals in Phase 1 trial VLA1553-1011.
  • If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.

Valneva Files for Chikungunya Vaccine Authorization with Health Canada

Retrieved on: 
Tuesday, May 30, 2023
Epidemic, Biologics license application, Pan American Health Organization, Saint-Herblain, Vaccination, Priority, Coalition, European Medicines Agency, Valneva SE, CEPI, PAHO, Coalition for Epidemic Preparedness Innovations, Licensure, Chikungunya, Person, Trial of the century, Fast track (FDA), EMA, Euronext Paris, VLA, MD, Instituto Butantan, PDUFA, Ageing, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Vaccine

Saint-Herblain (France), May 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the filing of a regulatory application with Health Canada for marketing approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 years and above.

Key Points: 
  • Saint-Herblain (France), May 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the filing of a regulatory application with Health Canada for marketing approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 years and above.
  • If accepted, Health Canada will provide additional information on the potential approval timeline.
  • This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023.
  • VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need.

Valneva Completes Enrollment for Adolescent Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Tuesday, February 14, 2023
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Saint-Herblain (France), February 14, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it completed enrollment and vaccination for a Phase 3 trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553.

Key Points: 
  • Saint-Herblain (France), February 14, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it completed enrollment and vaccination for a Phase 3 trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553.
  • The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination4.
  • The VLA1553-321 adolescent trial is also expected to support licensure of the vaccine in Europe and Brazil, which would be the first potential approval for use in endemic populations.
  • Conducted in collaboration between Instituto Butantan and Valneva, VLA1553-321 is a double-blinded, multi-center, randomized and placebo-controlled Phase 3 trial.

Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Monday, December 5, 2022
Euronext Paris, European, BLA, Infection, CEPI, EMA, Immunization, Vaccination, Mortality, VLA, Antibody, FDA, Marketing, Safety, Priority, Headache, Nausea, Vaccine, Human, Lyme disease, Fever, Interest group, Food and Drug Administration, LMIC, Disease, Ageing, Rash, SAE, Public health, Genome, Aedes, Alphavirus, Fast track (FDA), File, Dietary supplement, Pharmaceutical industry, Instituto Butantan, Valneva SE, CHIKV, Chikungunya

The antibody persistence trial enrolled 363 healthy adult participants and followed them from month 6 after vaccination to month 12.

Key Points: 
  • The antibody persistence trial enrolled 363 healthy adult participants and followed them from month 6 after vaccination to month 12.
  • These antibody levels confirm the antibody persistence profile observed in an earlier study3.
  • The antibody persistence was similar in older adults aged ≥65 years, who retained neutralizing antibody titers comparable to younger adults throughout the follow-up.
  • VLA1553 is a live-attenuated, single dose vaccine candidate targeting the chikungunya virus, which has spread to over 100 countries.

SINOVAC Approved to Initiate Clinical Trial for Its Omicron Containing COVID-19 Vaccine in Chile

Retrieved on: 
Tuesday, September 6, 2022
Research, Infectious Diseases, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Valence (chemistry), COVID-19, CEO, Safety, Program, Influenza A virus subtype H1N1, WHO, NASDAQ, Vaccine, Streptococcus, R, Infection, H5N1, Instituto Butantan, HFMD, Polio, Chickenpox, Hepatitis A, Mumps, ISP, Company, Foot-and-mouth disease virus, RNA transfection, Clinical trial, Delta, EV71, Sinovac Biotech, Omicron

In this phase II randomized, double-blind, multicenter clinical trial, 826 fully vaccinated adults will be recruited.

Key Points: 
  • In this phase II randomized, double-blind, multicenter clinical trial, 826 fully vaccinated adults will be recruited.
  • Mr. Weidong Yin, the Chairman, President, and CEO of SINOVAC said, SINOVAC has made great progress collaborating with global partners in the development and manufacturing of the COVID-19 vaccine.
  • Its COVID-19 vaccine, CoronaVac, has been approved for use in more than 60 countries and regions worldwide.
  • SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities.