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Full FDA Approval for Venclexta Combinations for Acute Myeloid Leukemia
The US FDA has granted its full approval to Venclexta (venetoclax) for newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older who are unfit for intensive induction chemotherapies.
The approval is based on the results of clinical trial Phase lll VIALE-A & VIALE-C. VIALE-A trial demonstrated a significant reduction in the risk of death and higher rates of complete remissions upon administration of Venclexta in a combination of azacytidine as compared to azacytidine alone. The drug has already bagged the accelerated FDA approval in this setting, and with the recent results, the drug has managed to get full approval.
Venclexta is a joint venture between AbbVie and Roche. Both the goliaths jointly commercialize it in the US, however, outside the US, AbbVie handles the marketing of the drug.
Positive EMA Opinion on Orphan status for Prestige Biopharma’s PBP1510 for Pancreatic Cancer
Prestige BioPharma has announced that it has secured Orphan Drug Designation (ODD) status for its first-in-class anti-PAUF monoclonal antibody, PBP1510 Pancreatic cancer by the European Medicines Agency (EMA).
The drug has already received the Orphan drug designation from the USFDA earlier this year in June, from the Korean Ministry of Food and Drug Safety during June and July, and now in Europe. The designation will open doors to several benefits such as market exclusivity for ten years for the drug.
NIH begins a large clinical trial to investigate Immunomodulators for COVID-19
The US National Institutes of Health (NIH) has initiated an adaptive Phase III clinical trial to test the safety and efficacy of three immunomodulators drugs in hospitalized adults with COVID-19 in the United States and Latin America.
Patients suffering from COVID-19 face cytokine storm, which is a result of inflammation due to uncontrolled amounts of proteins released by the immune system in response to virus attack that leads to ARDS, organ failure, and other complications. As per NIH, the study will focus on studying a combination of several treatment regimens with respect to illness severity, recovery speed, mortality, and hospital resource utilization in order to reduce hospital -stays and ventilator use.
The clinical trial, ACTIV-1 Immune Modulators, will enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19. The participants will be randomly assigned to receive one of the immunomodulators or placebo plus remdesivir.
Genesis Therapeutics, Roche together on the road to AI-driven drug discovery
Genentech, a subsidiary of Roche, has teamed up with Genesis Therapeutics, formed as a result of a spin-off from the Stanford University, to bolster the development of an AI-driven drug discovery platform to develop targeted drugs for several diseases.
The collaboration will let Genentech use Genesis’ Dynamic PotentialNet AI platform along with other novel neural network algorithms, while the latter will be eligible to receive upfront payments, milestone payments, and royalties on sales, however, the exact financial terms are not yet released.
It looks like Roche has decided to shoot to the top of the pharmaceutical market, hence is not shying away from doing whatever it takes. Earlier, the company collaborated with Dyno Therapeutics, acquired Spark Therapeutics, Vaccibody AS to expand its portfolio, and now it’s time for incorporating the technology and AI in its profile.