Cidofovir

Takeda Announces China NMPA Approval of LIVTENCITY® (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Refractory to Prior Therapies

Retrieved on: 
Thursday, December 21, 2023
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Transplant, SOT, CDE, CMV, Cidofovir, Incidence, Hospital, Week, NMPA, Ganciclovir, Infection, European, National Medical Products Administration, Cytomegalovirus, Valganciclovir, Patient, Safety, Foscarnet

Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
  • LIVTENCITY is the first and only inhibitor of CMV-specific UL97 protein kinase in China for this indication.
  • LIVTENCITY was granted Breakthrough Therapy Designation by China Center for Drug Evaluation (CDE) in 2021.
  • “This approval will help redefine the CMV treatment landscape for transplant patients in China and is a positive step forward toward addressing an unmet need for this community.”
    The NMPA approval is based on the results of the Phase 3 SOLSTICE trial, which evaluated the safety and efficacy of maribavir versus conventional antiviral therapies – ganciclovir, valganciclovir, cidofovir or foscarnet – for the treatment of patients with CMV infection/disease refractory* to prior therapies.

Global Monkeypox Treatment Market 2023 to 2035 - Featuring ACON Laboratories, altona Diagnostics, Jiangsu Bioperfectus Technologies and Elabscience Among Others - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 31, 2023
Infectious Diseases, Pharmaceutical, Health, Public health emergency of international concern, Vaccine, Laboratory, Human, Monkeypox virus, Therapy, Animal, Diagnosis, Viral disease, Contact tracing, World Health Organization, Developed country, ACAM2000, PCR, Patient, Cidofovir, Incidence, Research, PHEIC, Risk, WHO, Emergent, Disease, Growth, Smallpox, Public, Type, Polymerase chain reaction, Pharmaceutical industry, Mpox

In May 2022, multiple cases of the disease were reported in several non-endemic countries, thereby making monkeypox a disease of global concern.

Key Points: 
  • In May 2022, multiple cases of the disease were reported in several non-endemic countries, thereby making monkeypox a disease of global concern.
  • Consequently, in July 2022, the World Health Organization (WHO) declared global monkeypox outbreak a Public Health Emergency of International Concern (PHEIC).
  • Presently, more than 25 therapeutics / vaccines are commercialized / under development for the treatment and prevention of monkeypox.
  • Due to the surge in monkeypox cases in 2022, globally, there is a growing demand for monkeypox vaccines, therapeutics and diagnostic kits.

European Commission (EC) Approves LIVTENCITYTM▼ (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Infection And/or Disease That Are Refractory (With or Without Resistance) to One or More Prior Therapies

Retrieved on: 
Friday, November 11, 2022
Research, Surgery, Infectious Diseases, Clinical Trials, Stem Cells, Other Health, Biotechnology, Pharmaceutical, Health, Science, Foscarnet, Transplant, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Degenerative disease, Hospital, Organ transplantation, EEA, Food, Incidence, SOT, CMV, Valganciclovir, Disease, Plasma protein binding, Ganciclovir, EudraCT, Life, Adult, Tablet, Middle East Society for Organ Transplantation, Health Canada, Patient, Cytomegalovirus, Immunosuppression, Infection, Immune system, Safety, TAK, European Commission, Royal commission, EC, Liver, Kidney, Human, Cidofovir, Physician, Dentistry, Pharmaceutical industry, Dietary supplement, Takeda, HSCT, EU

With the EC approval of LIVTENCITY, we are privileged to offer healthcare providers in the EU and EEA* with an additional oral antiviral treatment for post-transplant refractory CMV.

Key Points: 
  • With the EC approval of LIVTENCITY, we are privileged to offer healthcare providers in the EU and EEA* with an additional oral antiviral treatment for post-transplant refractory CMV.
  • CMV DNA levels should be monitored and resistance mutations should be investigated in patients who do not respond to treatment.
  • Serum digoxin concentrations should be monitored, and dose of digoxin may need to be reduced, as needed (see Table 1).
  • Co-administration of maribavir with sensitive BCRP substrates such as rosuvastatin, is expected to increase their exposure and lead to undesirable effects.

Chimerix Announces Closing of TEMBEXA Sale to Emergent BioSolutions

Retrieved on: 
Monday, September 26, 2022
Adult, Tablet, Development, Human, Department, Contract, Sale, Food, BARDA, Administration, Biomedical Advanced Research and Development Authority, Company, Population, EBS, Economics, Private Securities Litigation Reform Act, Achievement, Emergent, Forward-looking statement, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, ONC201, Exercise, Emergent BioSolutions, Human services, Immunodeficiency, Orthopoxvirus, Smallpox, NASDAQ, DNA, GLOBE, Animal, Cidofovir, Pharmaceutical industry, Music, Vaccine

DURHAM, N.C., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the closing of its sale of TEMBEXA® to Emergent BioSolutions Inc. (EBS or Emergent).

Key Points: 
  • DURHAM, N.C., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Chimerix, Inc.(NASDAQ:CMRX), a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the closing of its sale of TEMBEXA to Emergent BioSolutions Inc. (EBS or Emergent).
  • The closing of our sale of TEMBEXA to Emergent allows Chimerix to accelerate the value of this product while still participating in its longer-term potential.
  • This would represent the first approved therapy specifically targeting patients with this invariably lethal disease, said Mike Sherman, Chief Executive Officer of Chimerix.
  • The closing amount was subject to the terms of the agreement executed between Biomedical Advanced Research and Development Authority (BARDA) and Chimerix for the procurement of TEMBEXA.

Takeda Receives Positive CHMP Opinion for Maribavir for the Treatment of Adults with Post-transplant Cytomegalovirus (CMV) Refractory (With or Without Resistance) to Prior Therapies

Retrieved on: 
Friday, September 16, 2022
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, Health, Infectious Diseases, Clinical Trials, Adult, Hospital, Maribavir, Degenerative disease, Safety, Committee for Medicinal Products for Human Use, Infection, Incidence, Human, Transplant, EudraCT, FDA, Food, Cidofovir, European Commission, Ganciclovir, Patient, Head, Foscarnet, SOT, European Medicines Agency, Valganciclovir, TAK, CHMP, EC, Committee, Cytomegalovirus, Marketing, Union, Food and Drug Administration, EMA, Disease, CMV, Immunosuppression, Dentistry, Pharmaceutical industry, HSCT, EU, Takeda

The European Commission (EC) will consider the CHMP positive opinion and decide upon potential marketing authorization in the coming months.

Key Points: 
  • The European Commission (EC) will consider the CHMP positive opinion and decide upon potential marketing authorization in the coming months.
  • Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI).
  • In this press release, Takeda is sometimes used for convenience where references are made to Takeda and its subsidiaries in general.
  • Maribavir for refractory cytomegalovirus infections with or without resistance post-transplant: results from a phase 3 randomized clinical trial.

Chimerix Awarded BARDA Contract for TEMBEXA as Medical Countermeasure for Smallpox

Retrieved on: 
Monday, August 29, 2022
Office of Inspector General, U.S. Department of Health and Human Services, Human, Tablet, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Government, Smallpox, NASDAQ, Cidofovir, Exercise, Achievement, ASPR, Sale, Food, BARDA, DNA, Forward-looking statement, Biomedical Advanced Research and Development Authority, U.S. Securities and Exchange Commission, EBS, Animal, ONC201, GLOBE, Emergent, Company, Transaction, Adult, Immunodeficiency, Private Securities Litigation Reform Act, Orthopoxvirus, Development, Patient, Vaccine, Real estate, Music

DURHAM, N.C., Aug. 29, 2022 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced that is has signed a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA) in the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response (ASPR), for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA® to the U.S. government. The contract 75A50122C00047, includes an initial product procurement of 319,000 treatment courses for approximately $115 million. The 10-year contract, which contains options for future procurements, is valued at approximately $551 million in total if BARDA elects to exercise all options. In addition to product procurement, the contract supports post-marketing activities of approximately $13 million, for a total potential contract value of up to $680 million.

Key Points: 
  • In addition to product procurement, the contract supports post-marketing activities of approximately $13 million, for a total potential contract value of up to $680 million.
  • Our collaboration with BARDA for the development of TEMBEXA has provided the United States government with a second therapeutic option to ensure the federal governments readiness for a potential smallpox emergency.
  • TEMBEXAs simple two dose oral regimen is the first approved smallpox treatment for all ages, including infants, said Mike Sherman, Chief Executive Officer of Chimerix.
  • In June 2021, the U.S. Food and Drug Administration granted approval of TEMBEXA for the treatment of smallpox as a medical countermeasure.

Cervical Cancer Drugs: Industry Trends and Opportunity Forecast, 2026 - ResearchAndMarkets.com

Retrieved on: 
Monday, August 15, 2022
Oncology, AIDS, Health, Consumer, Women, Pharmaceutical, Biotechnology, Woman, Z-100, Risk, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Inflammation, Novartis, Cervical cancer, Bristol Myers Squibb, Diagnosis, Bowen University, Growth, Cancer, Geography, College of Arts and Sciences, Prevalence, Allergan, Eli Lilly and Company, GlaxoSmithKline, Degenerative disease, Pessary, National, COVID-19, Company, Gel, Acquisition, CD4, ICH, Awareness, Human, CAGR, Forecasting, Alnylam Pharmaceuticals, Tablet, HIV, Vagina, Celgene, International Council, Harmonization, Immune system, Disease, Birth control, Pharmaceutical industry, Oil, Retail, Pfizer, Cidofovir

The "Cervical Cancer Drugs Global Market Report 2022, Cancer Type, Drug Type, Distribution Channel" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cervical Cancer Drugs Global Market Report 2022, Cancer Type, Drug Type, Distribution Channel" report has been added to ResearchAndMarkets.com's offering.
  • North America is the largest region in the cervical cancer drugs market in 2021.
  • The increasing prevalence of HIV (Human immunodeficiency virus) in women is driving the growth of the cervical cancer drugs market.
  • The lack of awareness and other misconceptions about cervical cancers hinder the growth of the cervical cancer drugs market.

Global Cervical Cancer Drugs Market (2021 to 2030) - Featuring Hetero, GlaxoSmithKline and Allergan Among Others - ResearchAndMarkets.com

Retrieved on: 
Monday, December 20, 2021
General Health, Pharmaceutical, Health, Oncology, Benchmark, Oncology Drug Advisory Committee, Oncology, Cervical cancer, FDA, Z-100, CD4, Awareness, Diagnosis, Gel, ICH, Division, Harmonization, Create, Human, Bowen University, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, National, Safety, Prevalence, Disease, Gynecologic cancer disparities in the United States, Risk, Woman, Tablet, College of Arts and Sciences, Coronavirus, Food, Immune system, HIV, Vagina, International Council, Growth, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pessary, Marketing, Birth control, Cidofovir

The increasing prevalence of HIV (Human immunodeficiency virus) in women is driving the growth of the cervical cancer drugs market.

Key Points: 
  • The increasing prevalence of HIV (Human immunodeficiency virus) in women is driving the growth of the cervical cancer drugs market.
  • The lack of awareness and other misconceptions about cervical cancers hinder the growth of the cervical cancer drugs market.
  • For instance, companies introduced vaginal gels such as Cidofovir gel and 851B Gel into the market to treat cervical cancer.
  • In addition to the above mentioned gels, drugs such as ISA101, AGEN2034 and Z-100 are in pipeline and promise growth to the cervical cancer drugs market.

Amber Specialty Pharmacy Selected by Takeda to Dispense LIVTENCITY™ (maribavir) for the Treatment of Adults and Pediatric Patients with Post-Transplant CMV Infection/Disease that is Refractory to Treatment

Retrieved on: 
Friday, December 3, 2021
Retail, Health, Supermarket, Specialty, General Health, Pharmaceutical, Patient, URAC, Pharmacy, Death, Attention, Partnership, Accreditation Commission for Health Care, Transplant, Human, Cidofovir, Takeda, National Association, Ganciclovir, Valganciclovir, Foscarnet, Person, SOT, Immunosuppression, Degenerative disease, ACHC, HCT, CMV, Specialty pharmacy, Dentistry, Hospital

Through this partnership, Amber Specialty Pharmacy's best-in-class service model will support transplant facilities and patients throughout the country.

Key Points: 
  • Through this partnership, Amber Specialty Pharmacy's best-in-class service model will support transplant facilities and patients throughout the country.
  • Amber Specialty Pharmacy was established in 1998 as the first specialty pharmacy to focus on the life-long health and needs of the transplant community.
  • Amber Specialty Pharmacy has built an exceptional reputation by providing personalized support and quality clinical care to patients and families.
  • Amber Specialty Pharmacy was named the 2020 Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy.

Takeda’s LIVTENCITYTM (maribavir) Approved by U.S. FDA as the First and Only Treatment for People Ages 12 and Older with Post-Transplant Cytomegalovirus (CMV), Refractory (With or Without Genotypic Resistance) to Conventional Antiviral Therapies

Retrieved on: 
Tuesday, November 23, 2021
Health, FDA, Infectious Diseases, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Patient, FDA, Takeda Pharmaceutical Company, Regulation of tobacco by the U.S. Food and Drug Administration, TAK, Ganciclovir, Cidofovir, Adult, CMV, Valganciclovir, Food, Dentistry, Takeda, CMV, LIVTENCITY, Takeda Pharmaceutical Company Limited, TAKEDA, CMV, LIVTENCITY, TAKEDA PHARMACEUTICAL COMPANY LIMITED

For appropriate patients, physicians can submit a prescription to initiate access to treatment by contacting Takeda Patient Support at 1-855-268-1825.

Key Points: 
  • For appropriate patients, physicians can submit a prescription to initiate access to treatment by contacting Takeda Patient Support at 1-855-268-1825.
  • In clinical studies, we observed LIVTENCITY was statistically superior to conventional antiviral therapies in achieving the primary endpoint at Week 8.
  • Takeda Patient Support is available to help patients prescribed LIVTENCITY gain access to their medication, find educational resources, and understand financial assistance options.
  • Monitor CMV DNA levels and check for maribavir resistance if the patient is not responding to treatment or relapses.