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Innovation in immuno-oncology: Leading companies in in-vitro T-cell activation

Pharmaceutical Technology

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: In-vitro T-cell activation. Immatics is the leading patent filer in in-vitro T-cell activation.

In-Vitro 130
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CDSCO releases draft guidance document on stability studies of IVD Medical Devices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The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the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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Codivir Shows Promising Effect Against COVID-19

Pharma Mirror

In-vitro studies conducted at the British virology research laboratory Virology Research Services in London then demonstrated a potent antiviral activity against SARS-CoV-2 and other RNA viruses. Code Pharma discovered that the peptide had a direct antiviral effect against SARS-CoV-2, the novel Coronavirus causing COVID-19.

In-Vitro 245
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Skipping Informed Consent for In Vitro Diagnostic (IVD) Trials: Understanding the Exceptions

Cloudbyz

Understanding the exceptions in Informed consent is an essential aspect of ethical clinical research because it concerns full awareness of risks and benefits related to research, as well as procedures. Regulatory and Institutional Review Board Approval : Any informed consent waiver should be reviewed and approved by an IRB or an EC.

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CDSCO releases draft standard evaluation protocols for issuing license for IVDs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.

Licensing 180
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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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World Orphan Drug Congresses Europe vs. The US: Global Perspectives on Genetic Testing

Worldwide Clinical Trials

As more research into genetic testing is being done and various labs are selected, the baseline reference transcripts used to read the genetic data may differ. One topic that sparked this dialogue is the potential bankruptcy of 23andMe, a direct-to-consumer genetic testing company. conversation was highly operationally focused.

Genetics 130