Tags : Against

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

Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study

Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany The results divulge that BNT162b1 candidate induced strong CD4+ and CD8+ T-cell responses. BNT162b1 elicits RBD-specific, interferon-g+, […]Read More

Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against

Shots: Zydus has commenced the adaptive P-I/II human clinical trials of its plasmid DNA vaccine, ZyCoV-D and reported its first human dosing The Adaptive P-I/II dose escalation study will assess the safety, tolerability, and immunogenicity of the vaccine in ~1000 candidates across multiple clinical sites in India. The company has already manufacture clinical GMP batches […]Read More

Merck Animal Health Receives the US FDA’s Approval for Bravecto

Shots: The US FDA approves Bravecto 1-month (fluralaner) chews for dogs and puppies aged≥ 8 weeks. The approval will expand Merck’s parasiticide portfolio, which are extended duration flea and tick protection products offering parasite protection for dogs The product is suitable for dogs in the early stages of life to begin a regimen of monthly […]Read More

Merck Collaborates with Foghorn to Develop Oncology Therapies Against Transcription

Shots: Foghorn will receive an upfront, development, regulatory and commercial milestones totaling up to $425M as well as royalties on sales of any approved therapy emerges from the collaboration Merck to get an exclusive global right to develop and commercialize drugs targeting dysregulation of a single transcription factor. The collaboration will deploy Foghorn’s Gene Traffic […]Read More

Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in

Shots: The ongoing P-I/II study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1 (10µg & 30µg/ 100 µg) vs PBO in 45 adults aged 18-55yrs. Results: @28days (7days after dose 2), neutralizing GMTs (168 & 267) corresponding to 1.8- and 2.8-times GMT of the convalescent serum panel; elevated RBD-binding IgG […]Read More

AstraZeneca Signs an Agreement with Symbiosis for Sterile Manufacturing of

Shots: Symbiosis will provide AstraZeneca access to its sterile vaccine drug product manufacturing capacity for clinical trial supply The agreement follows AstraZeneca’s licensing agreement with the University of Oxford for the global development, manufacturing, and distribution of the AZD1222 vaccine candidate. The vaccine candidate is currently in clinical trials at multiple sites in the UK […]Read More