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Synlogic’s SYNB1934 receives orphan drug status from US FDA

Pharmaceutical Technology

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The orally administered, non-systemically absorbed drug candidate SYNB1934 has been designed for reducing blood phenylalanine (Phe) levels in PKU patients.

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CIGB-128 by Center for Genetic Engineering and Biotechnology for Brain Tumor: Likelihood of Approval

Pharmaceutical Technology

CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. According to GlobalData, Phase I drugs for Brain Tumor does not have sufficient historical data to build an indication benchmark PTSR for Phase I. Buy the report here.

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CIGB-128 by Center for Genetic Engineering and Biotechnology for Brain Tumor: Likelihood of Approval

Pharmaceutical Technology

CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. According to GlobalData, Phase I drugs for Brain Tumor does not have sufficient historical data to build an indication benchmark PTSR for Phase I. Buy the report here.

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Enabling the next wave of innovative drug therapies with speciality enzymes

Pharmaceutical Technology

The pharmaceutical industry often relies on enzymes to perform a process known as biocatalysis, which facilitates the cost-effective and sustainable production of small molecule drugs at scale. Novozymes has a long legacy of enzyme discovery and the ability to genetically engineer these speciality enzymes to be superior.

Drugs 295
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Boston Pharmaceuticals Licenses Potential NASH Treatment from Novartis

BioSpace

Boston Pharmaceuticals licensed the drug candidate BOS-580, an injectable, genetically engineered variant of human FGF21.

Licensing 111
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US FDA grants orphan drug status to IN8bio’s INB-400 and INB-410

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). This marks the first-ever designation for genetically modified gamma-delta T cell therapies.

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FDA Approves Genetically Engineered Pigs for Food, Possible Medical Use

The Pharma Data

FDA Approves Genetically Engineered Pigs for Food, Possible Medical Use. 14, 2020 — The first genetically engineered pigs for use as food or for potential future biomedical use — such as transplantation — in humans have been approved by the U.S. Food and Drug Administration. Professional.