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World Orphan Drug Congresses Europe vs. The US: Global Perspectives on Genetic Testing

Worldwide Clinical Trials

At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing.

Genetics 130
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The drug Fenbendazole can make tumors sensitive to radiotherapy just like agents of chemotherapy

Pharma Mirror

The post The drug Fenbendazole can make tumors sensitive to radiotherapy just like agents of chemotherapy appeared first on Pharma Mirror Magazine. 2] Presumably, fenbendazole multitherapy along with this little. 2] Presumably, fenbendazole multitherapy along with this little.

In-Vitro 246
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CDSCO releases draft guidance document on stability studies of IVD Medical Devices

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

In-Vitro 241
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Enanta secures FDA fast track designation for EDP-323 to treat RSV

Pharmaceutical Technology

Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV). In vitro data of EDP-323 showed a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B.

In-Vitro 276
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DCGI emphasises need for sample test for standards for medical devices and IVDs

AuroBlog - Aurous Healthcare Clinical Trials blog

Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi has emphasised that the medical devices and in-vitro diagnostics (IVD) sold in the county should be tested for the standards prescribed by the Bureau of Indian Standards (BIS) for its quality and performance in the country.

In-Vitro 189
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CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

In-Vitro 189
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Preclinical Data on New Pancreatic Cancer Drug Shines with over 90% Efficacy

BioSpace

Preclinical data for its drug candidate, LP-184, reportedly showed over 90 percent efficacy in shrinking pancreatic cancer tumors in mouse models in vitro, in-vivo, and ex-vivo.

In-Vivo 145