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A winning combination: The benefits of micronization and containment in a single installation

Pharmaceutical Technology

This, coupled with small pharma companies being unable to acquire or access containment capabilities in-house, means that the demand for innovative specialized small molecule capabilities remains high. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.

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Novaliq’s dry eye disease therapy receives US FDA approval

Pharmaceutical Technology

VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1%

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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. Dosing flexibility is another prominent advantage provided by PDFs.

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Solving pharma’s process development challenges one API at a time

Pharmaceutical Technology

The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. This is where the process development stage, which directly follows the drug discovery and early formulation work, can make or break a drug’s success.

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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective.

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PureTech Reveals New CBD Pill to Rival Jazz’s Epidiolex

XTalks

Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups. Jazz bought out Epidiolex developer GW Pharmaceuticals for the drug in a whopping $7.2

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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. The FDA also issued the Study Data Technical Conformance Guide , which contains detailed information on how to meet the requirements contained in the DSC.