Pharma News

Premas Biotech, a developer of novel biotherapeutic and vaccine candidates announced that Oravax Medical Inc., a US based company that Premas Biotech is a partner in, has received clearance from the South African Health Products Regulatory Authority to commence patient enrollment in a first in human, Phase 1 clinical trial, for its oral COVID-19 vaccine; and preparations to begin the trials are now underway.

Pfizer Inc and BioNTech SE announced that the U.S. Food and Drug Administration has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age.

When you clicked to read this story, a band of cells across the top of your brain sent signals down your spine and out to your hand to tell the muscles in your index finger to press down with just the right amount of pressure to activate your mouse or track pad.

A slew of new studies now shows that the area of the brain responsible for initiating this action — the primary motor cortex, which controls movement — has as many as 116 different types of cells that work together to make this happen.

Research led by scientists at the National Institutes of Health has identified two distinct ways that people with HIV can control the virus for an extended period after stopping antiretroviral therapy (ART) under medical supervision. This information could inform efforts to develop new tools to help people with HIV put the virus into remission without taking lifelong medication, which can have long-term side-effects.

Systemic lupus erythematosis (SLE) is an autoimmune disease in which the immune system targets tissues of the body, causing widespread inflammation and affecting multiple organs such as the kidney and the brain. The gut microbiome all the micro-organisms that live in the human gut is known to be altered in SLE patients. Now, a research team at Osaka University has comprehensively profiled the associations between the gut microbiome and SLE.

Takeda Pharmaceutical Company Limited announced the exercise of its option to acquire GammaDelta Therapeutics Limited (“GammaDelta”), a company focused on exploiting the unique properties of gamma delta (γδ) T cells for immunotherapy. Through the acquisition, Takeda will obtain GammaDelta’s allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy platforms, which includes both blood-derived and tissue-derived platforms, in addition to early-stage cell therapy programs.

Vifor Pharma andAngion Biomedica Corp announced that the phase-III trial of Angion’s ANG-3777 did not demonstrate a statistically significant difference from placebo on the primary endpoint (eGFR at 12 months) in the population of deceased donor kidney transplant patients who were at risk for developing DGF.

Silver Bullet Therapeutics, Inc a privately-held medical device company, announced today that it is formally launching its antimicrobial OrthoFuzIon Bone Screw System at the DKOU German Congress of Orthopedics and Traumatology on October 26-29 in Berlin.

Silver Bullet Therapeutics OrthoFuzIon product line will be featured at the Argomedical booth at Nr. 61 in Hall 4.2.

Roche announced that it has launched the AVENIO Tumor Tissue CGP Kit. The Kit complements the current CGP portfolio offered by Roche and Foundation Medicine and allows laboratories to expand their oncology research in-house. Ultimately, a future version of the kit may lead to additional resources for clinicians to use in the diagnosis and treatment of cancer.