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Pfizer Wins New Pediatric Approval for Atopic Dermatitis Ointment Eucrisa

The U.S. FDA greenlit a new pediatric approval for Pfizer’s Eucrisa ointment in the treatment of mild-to-moderate atopic dermatitis, an inflammatory skin disease that impacts a large number of pre-adolescent children. Pfizer announced late Monday that the FDA approved a...

OliX Pharmaceuticals Advances RNAi Approaches to Target Highly Conserved Regions of Coronavirus RNAs

OliX Pharmaceuticals, Inc. , a leading developer of RNA interference (RNAi), announced that it will leverage previous preclinical research for developing siRNA therapeutics in treating respiratory illnesses to investigate a path forward for developing a COVID-19 therapy. COVID-19 belongs to...

Univercells launches new CDMO for cell and gene therapy sector

The company’s new CDMO, Exothera, has been created to help the cell and gene therapy sector increase its capacity, and also boost its bioprocessing expertise. The CDMO will create bespoke bioproduction support programmes for manufacturers to achieve successful market...

CytomX Therapeutics and Astellas Announce Strategic Collaboration to Develop Probody T-Cell Engaging Bispecific Therapies

CytomX Therapeutics, Inc and Astellas Pharma Inc. announced they have entered into a strategic collaboration agreement focused on the discovery, research, development and commercialization of novel T-cell engaging bispecific antibodies targeting CD3 and tumor cell surface antigens for the...

PBOA Members Committed To Continuing To Reliably Manufacture Drug and Vaccine Products

The Pharma & Biopharma Outsourcing Association (PBOA), a trade group that represents Contract Manufacturing Organizations (CMOs) and other service providers in the bio/pharmaceutical sector, reports that its member companies remain committed to serving patients by manufacturing effective, quality products...

Alembic Pharma receives 4 observations from USFDA for Panelav facility

Alembic Pharmaceuticals on Monday said that US health regulator has conducted an inspection at it Panelav facility in Gujarat and issued Form 483 with four procedural observations. "The US Food and Drug Administration (USFDA) has conducted an inspection at Alembic...

Roches cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization

Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal...

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