Tags : Trial

Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to

Shots:  The independent DSMB recommended pausing the enrollment of the ACTIV-3 clinical trial. The trial is evaluating Lilly’s bamlanivimab (LY-CoV555, 7000mg) + remdesivir as a treatment for COVID-19 in hospitalized patients, and is sponsored by the NIAID Lilly trusts the judgment & supports independent DSMB decisions to exercise caution in ensuring the safety of the […]Read More

BMS Report Results of Opdivo (nivolumab) + CT in P-III

Shots: The P-III CheckMate-816 study involves assessing of Opdivo (360mg) + CT (q3w for 3 doses) vs CT (q3w for 3 doses), followed by surgery as a neoadjuvant treatment in 358 patients with resectable NSCLC The study met its 1EPs of improved pathologic complete response. The positive results mark the first time an immune checkpoint […]Read More

Formycon with its Partner BIOEQ Plans to Initiate P-III MAGELLAN-AMD

Shots: BIOEQ will sponsor the P-III study which will assess the FYB203 vs Eylea in patients with neovascular age-related macular degeneration (nAMD) to evaluate its efficacy, safety and immunogenicity. Additionally, the design of the study is developed in collaboration with the USFDA, EMA, PMDA The second program in ophthalmology will aim to strengthen and expand […]Read More

Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July,

Shots: Moderna has reported the robust results of its ongoing P-I study that demonstrated mRNA-1273 at (25-, 100- & 250-mcg dose levels) induced anti–SARS-CoV-2 immune responses in all participants with no trial-limiting safety concerns. These results were published in NEJM All participants seroconverted by the 15-day mark. Post two vaccinations, @57day, geometric mean titers exceeded […]Read More

GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19

Shots: The two companies collaborated to develop a COVID-19 vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. The partners are planning to initiate P-I study in mid-July followed by pre-clinical results that showed combining the two platforms demonstrated a high level of neutralizing Abs following a single dose The study […]Read More

Regeneron with its Partner NIAID Report the Initiation of P-III

Shots: The P-III trial involves assessing REGN-COV2 with an expected enrollment of 2000 patients at 100 sites which will be evaluated to prevent infection among uninfected people who have had close exposure to a COVID-19 patient REGN-COV2 is also being evaluated in P-II/III portion of two P-I/II/III trials testing the cocktail’s ability to treat hospitalized […]Read More

Henlius Reports Positive Results of HLX04 (biosimilar, bevacizumab) in P-III

Shots: HLX04 is a biosimilar that binds to vascular endothelial growth factor (VEGF) for inhibiting angiogenesis where VEGF acts for promoting growth of blood vessels can inhibit tumor angiogenesis further preventing tumor growth or metastasis. The biosimilar was developed under Chinese biosimilar guideline The P-III HLX04-mCRC03 trial involves assessing of HLX04 (biosimilar, bevacizumab) or Avastin […]Read More

NIH Initiates its P-I Trial for COVID-19 at KPWHRI in

Shots: The study involves assessing of investigational vaccine mRNA-1273 against COVID-19 enrolling 45 patients with age of 18 to 55 years ~6wks. and the first patient has been dosed. Additionally, National Institute of Allergy and Infectious Diseases (NIAID) is funding the P-I trial The study will be evaluating two doses of the vaccine (IM, 25mcg, […]Read More

Nektar Therapeutics Signs a Clinical Trial Collaboration with Bristol-Myers Squibb

Shots: The collaboration will evaluate Nektar Therapeutics’ bempegaldesleukin in combination with BMS’ Opdivo (nivolumab) into multiple new registrational trials and the cost of trials will be shared upon the cost-sharing outlined in the terms of the original collaboration agreement The companies have expanded their collaboration for bempeg + nivolumab from three ongoing registrational trials targeted […]Read More