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Novaliq’s dry eye disease therapy receives US FDA approval

Pharmaceutical Technology

CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% The water-free formulation of the investigational drug increases residual time on the surface of the eye and improves bioavailability in the target tissues to release the complete potential of cyclosporine A.

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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. Epidiolex contains sesame seed oil, restricting its use for some individuals.

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

Camargo

The FDA also issued the Study Data Technical Conformance Guide , which contains detailed information on how to meet the requirements contained in the DSC. 3.1.1: Bioavailability Study Reports. 3.1.1: Bioavailability Study Reports. Where Are the Technical Rejection Criteria for Study Data Applied? Validation Code.

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Calliditas Announces Full Enrollment of the Phase 3 NefIgArd Trial

The Pharma Data

21, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX: CALTX) (NASDAQ: CALT) today announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

Trials 52
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Solving pharma’s process development challenges one API at a time

Pharmaceutical Technology

If clinical trials prove successful, that same process should then be scaled to commercial manufacturing. Milling is a central part of powder processing, as this is where coarse particles are broken down into smaller ones for a variety of processability, bioavailability, reactivity, and safety-related reasons.

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Vevye: A New Cyclosporine Solution for Dry Eye Disease

XTalks

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology.

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Microparticle analysis: methods and uses in the pharmaceutical industry

Pharmaceutical Technology

Within the pharmaceutical industry, it is critical to measure particle size as it influences surface area and porosity, impacting a drug’s bioavailability, effectiveness, and shelf life. Alternatively, they can come as a product component of formulations such as cleaning agents and polymers.