Business Wire India

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced the closing of the previously announced acquisition of Lyophilization Services of New England, Inc. (LSNE), a premier contract development and manufacturing organization headquartered in Bedford, New Hampshire.

Vifor Pharma announced that the first patient has been enrolled in a double-blind, randomized phase-IIa clinical trial evaluating the safety, efficacy and tolerability of vamifeport in adult patients with sickle cell disease. Vamifeport, developed by Vifor Pharma, is a novel oral ferroportin inhibitor investigated for treatment of diseases characterized by ineffective production of red blood cells and iron overload, including SCD and beta-thalassemia. It has been granted orphan drug designation from both the U.S.

Vifor Pharma and Angion Biomedica Corp announced results from the exploratory phase-II GUARD trial of Angion’s ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data, based on the signal demonstrated in the clinically-relevant MAKE90 secondary endpoint.

LintonPharm Co., Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T cell engaging bispecific antibodies for cancer immunotherapy, today announced that the first patient has been dosed in the Company’s Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

Premas Biotech announced that its joint venture Oravax will initiate testing of their oral virus-like particle (VLP) vaccine candidate against Omicron variant of SARS-CoV 2 virus through preclinical, in vitro and challenge studies to assess its efficacy for the new mutant strain. Premas Biotech, Oramed Pharmaceuticals, MyMD Pharmaceuticals, and certain other shareholders formed Oravax Medical to bring an oral COVID-19 vaccine to the market.

Icure Pharmaceutical Inc a biopharmaceutical company in Korea, announced that its donepezil patch, a treatment of Alzheimer’s-type dementia, received a drug product approval from the Ministry of Food and Drug Safety of Korea.

The drug product approval process took 7 months after it filed an application in April 2021. With the approval, Icure marks the first commercialization of the donepezil patch in the world.

ONWARD Medical N.V a medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today announced Grégoire Courtine, Ph.D., Professor of Neuroscience at the Swiss Federal Institute of Technology (EPFL) and co-Director of NeuroRestore, demonstrated the effectiveness of ONWARD’s ARC Therapy to stabilize blood pressure after spinal cord injury during his Presidential Special Lecture at NEUROSCIENCE 2021.

Celltrion Group announced that the European Medicine’s Agencys Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion recommending marketing authorisation for regdanvimab (CT-P59), a monoclonal antibody treatment for adults with COVID-19 that do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The CHMP positive opinion is a scientific recommendation to the European Commission (EC), which authorises marketing approval in the European Union.

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.