Tags : Candidate

COVID-19 Regulatory

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273

Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed through 12mos. after the second vaccination. Takeda has completed enrollment […]Read More

Clinical Trials COVID-19

Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted

Shots: Clover plans to initiate a global P-II/III efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the H1’2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021 Additionally, Clover discontinued their partnership with GSK to evaluate the S-Trimer vaccine candidate with GSK’s pandemic adjuvant […]Read More

Pharma

Lilly Signs a License Agreement with Asahi Kasei Pharma for

Shots: Asahi Kasei to receive an $20M up front, ~$210M as development & regulatory milestones and will be eligible for ~$180M milestones along with royalties on sales of the therapy. Lilly to acquire the exclusive rights for AK1780 while Asahi Kasei will retain the right to promote AK1780 in Japan and China (including Hong Kong […]Read More

Biotech

J&J and US Government Amends their Agreement for the Next

Shots: J&J and the US Department of Health and Human Services have expanded an agreement to support the next phase of COVID-19 vaccine candidate research and development Janssen will commit ~$604M while BARDA will commit ~$454M to support the ongoing P-lll ENSEMBLE study assessing Janssen’s JNJ-78436735 as a single-dose in ~60,000 patients globally J&J affirmed […]Read More

Biotech

GSK Presents Results of Maternal & Older Adults RSV Vaccines

Shots: GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults […]Read More