Tags : Candidate

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

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

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2

Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process […]Read More

Pfizer Initiates Clinical Study of Eighth Candidate Emerges Under the

Shots:   Sosei Heptares to receive $5M as milestones triggered by the dosing of the first subject in a clinical trial. In Jun’2019, Pfizer nominated the candidate for advancement and granted $3M as milestones   The companies collaborated in 2015 to develop therapies directed at up to ten GPCR targets across multiple therapeutic areas. The collaboration […]Read More

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead

Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2 The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 […]Read More

CSL Behring to Acquire uniQure’ Hemophilia B Candidate (AMT-061) for

Shots: uniQure to receive $2B+ including $450M as up front in cash, $1.6B as regulatory & commercial milestones along with royalties in sales of  AMT-061 (etranacogene dezaparvovec) while CSL Behring to get an exclusive global right to commercialize AMT-061 uniQure will be responsible for the completion of the P-III HOPE-B study and scale-up manufacture for […]Read More

Roche Signs a License Agreement with Sarepta for its Gene

Shots: Sarepta to receive $1.15B up front including $750M in cash $400M in Sarepta stock, priced at $158.59/share of common stock, up to $1.7B regulatory and sales milestones plus royalties on sales. Sarepta will be responsible for SRP-9001’s clinical development and manufacturing with global clinical cost equally shared Roche to get exclusive rights to commercialize […]Read More

Pfenex Reports Results of Human Factors Study for its PF708

The follow on study involves assessing of PF708 vs Forteo in 102 patients including 52 with osteoporosis and 50 with caregivers The study demonstrated PF708 had fewer or equal user errors showing 33% and 17 % of critical tasks respectively further concluded that the study data of user interface of the FDA-approved PF708 product is […]Read More