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Key Considerations for Generic Drug Stability Testing

Drug Patent Watch

The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? For generic drug manufacturers, stability testing is a critical step in the development process.

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The rising importance of containment in small molecule drug development

Pharmaceutical Technology

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. HPAPIs may now represent more than 30% of the drug development pipeline. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.

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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. This research dates to the mid-2000s when CDC scientists developed the PrEP regimen, argued the government.

Drugs 264
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Scientists Urge the FDA to Ban Red 3 Color Additive

XTalks

As a result, in 1990, the agency eliminated certain “provisionally listed” uses of the chemical — meaning cosmetics and externally applied drugs. That same year, the FDA also said it would “take steps” to ban its use in foods, ingested drugs and supplements. But those steps were never taken.

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Ex-Merck & Co scientist accused of stealing trade secrets could face jail

pharmaphorum

A former Merck & Co scientist could face up to 10 years in prison after he was accused of stealing trade secrets relating to drugs including the cancer immunotherapy Keytruda by US authorities. The post Ex-Merck & Co scientist accused of stealing trade secrets could face jail appeared first on.

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Leading payers in the pharmaceutical industry

Pharmaceutical Technology

Documentation for a faster drug authorisation process. The information in the download document is intended for executives, manufacturers, distributors, suppliers, technicians, research scientists, product development scientists, and other individuals involved in the pharmaceutical industry.

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FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation

Camargo

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Criteria for Orphan Drug Designation.