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Roche subcutaneous cancer immunotherapy granted MHRA approval

European Pharmaceutical Review

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. The safety and efficacy profile was consistent with the IV formulation.

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Roche cancer immunotherapy receives new EU approval

European Pharmaceutical Review

Compared with standard intravenous (IV) delivery, Roche stated that its monoclonal antibody biologic shortens treatment time by approximately 80 percent. The European Commission (EC) has approved the EU’s first PD-(L)1 cancer immunotherapy for subcutaneous injection.

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Formulation Strategies for Large Molecule Drug Products

Syner-G

Large molecule drug products produce highly effective medicines, but formulation can be challenging because of their complexity, sensitivity, and potential for instability. It is crucial that formulation strategies ensure their bioavailability and efficacy to develop new and successful products.

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A game of two halves for Roche’s recently approved wet AMD assets

Pharmaceutical Technology

Susvimo’s recall is due to a problem related to the seal on the port delivery device, which keeps the medicine from leaking out once it has been injected. For one, the need to insert this implant via a surgical route represents a resource-intensive procedure and is likely to limit its wider adoption in the market.

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Getting Quality Supplements

The Thyroid Pharmacist

I even started my own line of supplements, because there were certain formulations I had a hard time finding a trusted source for. Rootcology – US Rootcology is my own brand of supplements, specially formulated for those with thyroid disease. I hope the resources above are helpful for you.

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Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Doing more for patients with chronic conditions.

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Ensuring Product Safety: U.S. FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

Quality Matters

Excipients, or inactive ingredients, in a drug formulation are critical components, comprising up to 90% of a drug formulation by volume and serving important functions such as improving stability and increasing bioavailability for targeted drug delivery. The guidance document is available here: [link].)