In 2021, Takeda (TYO:4502) announced that it would manufacture 150 million doses of COVID-19 vaccine from NovaVax (Nasdaq:NVAX). But the company has disclosed that the Japanese government has canceled the remaining order for the Nuvaxovid vaccine. The Japanese government acquired 8.24 million vaccine doses but said it would cancel the remaining order for the remaining…
A closer look at the potential of Takeda’s Takhzyro in pediatric hereditary angioedema study
Takeda (NYSE:TAK) recently announced that in the open-label Phase 3 SPRING study, children aged 2 to 12 had 94.8% fewer hereditary angioedema (HAE) attacks when receiving Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline The primary objectives of the SPRING study was to evaluate the safety and pharmacokinetics of Takhzyro in HAE patients aged 2…
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Takeda (NYSE:TAK) has announced that in the open-label Phase 3 SPRING study, children aged 2 to 12 had 94.8% fewer hereditary angioedema (HAE) attacks during treatment with Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline. The Osaka, Japan–based company plans on presenting the data at the European Academy of Allergy and Clinical The SPRING study…
Takeda wins approval to distribute Novavax’s COVID-19 vaccine in Japan
Takeda (NYSE:TAK) has announced that it has won manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid, a novel COVID-19 vaccine. Nuvaxovid (NVX-CoV2373) was initially developed by Novavax (Nasdaq:NVAX). The approval covers the use of the vaccine as both a primary and booster immunization in adults at least…
Takeda’s Takhzyro hit primary endpoints in pediatric hereditary angioedema trial
The plasma kallikrein inhibitor Takhzyro (lanadelumab) from Takeda (TSE:4502/NYSE:TAK) met its objectives in a Phase 3 study focused on hereditary angioedema (HAE) in children aged 2 to 12 in an open-label Phase 3 study. In the SHP643-301 multicenter, open-label study, Takhzyro also had a safety profile similar to that observed in clinical trials focused on…
Takeda wins Japanese approval for Takhzyro as a prophylaxis against acute attacks of hereditary angioedema
Takeda (TSE:4502/NYSE:TAK) has received approval from Japanese regulatory authorities for subcutaneous injection of the monoclonal antibody Takhzyro (lanadelumab) as a prophylaxis against acute attacks of hereditary angioedema (HAE) in individuals at least 12 years old. HAE involves recurring episodes of severe (angioedema) in various body parts such as the abdomen, limbs, face, intestinal tract, genitals,…
J&J and Roche named to Clarivate’s Top 100 Global Innovators list
Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT). Two companies in pharma and another in medtech, however, made the cut. Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator. Roche was included for the 11th consecutive year…
FDA places clinical hold on Denali Therapeutics’ IND for Alzheimer candidate DNL919
Denali Therapeutics (NASDAQ:DNLI) has announced that the FDA has placed a clinical hold on the Investigational New Drug (IND) application for DNL919. The large-molecule drug candidate targets TREM2 or triggering receptor expressed on myeloid cells 2. South San Francisco–based Denali said it received an email from FDA stating that the agency had placed the IND…
Takeda publishes Phase 3 Livtencity data in peer-reviewed journal
Takeda Pharmaceutical (TSE:4502/NYSE:TAK) has announced that it has published data from the SOLSTICE Phase 3 trial for Livtencity (maribavir) in post-transplant recipients with cytomegalovirus (CMV) infection in the peer-reviewed journal of Clinical Infectious Diseases. The drug was statistically superior to conventional therapies at week 81. The trial met its primary endpoint. A total of 55.7%…
European initiative launched to develop COVID-19 treatment
The Corona Accelerated R&D in Europe (CARE) consortium today announced its launch to accelerate the development of COVID-19 treatments. Supported by the Innovative Medicines Initiative, the new consortium has collected $92.7 million (€77.7 million) in grant funding in an effort to conduct a 5-year project, bringing together 37 partners from Belgium, China, Denmark, France, Germany,…
Takeda’s Brintellix Renamed Trintellix
Takeda Pharmaceuticals U.S.A., Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502) (collectively “Takeda”), and Lundbeck announced that Brintellix (vortioxetine) will be marketed in the United States under the new name Trintellix (vortioxetine) starting in June of 2016. The vortioxetine product is a prescription medicine approved to treat Major Depressive Disorder (MDD) in adults. The…