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Gilead, having resolved manufacturing issues, forges ahead with HIV drug

Bio Pharma Dive

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

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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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Understanding the rules on HPAPI containment in high potent manufacturing

Pharmaceutical Technology

How to ensure safety and quality in pharmaceutical facilities when using HPAPIs in drug development. Read more here.

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Resolving challenges with product recovery in biopharma manufacturing

Pharmaceutical Technology

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. However, costs need to fall to improve access to these life-saving therapies.

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Innovative Approaches to Generic Drug Development: Case Studies

Drug Patent Watch

The Generic Drug Revolution: Setting the Stage Before we dive into the nitty-gritty, let’s take a moment to appreciate the impact of generic drugs. Did you know that generic drugs now make up about 90% of all prescription drug purchases in the United States, while accounting for only 20% of prescription drug spending[1]?

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Expert Insights: Development and Manufacture of Highly Potent Oral Liquids

XTalks

In 2020, the US Food and Drug Administration (FDA) issued a Guidance for Industry recommending that sponsors include plans for developing age-appropriate formulations of drug products in instances where adult formulations may not be suitable for paediatric patients.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.