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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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Synthesis-to-Clinic®: integrating isotopic labeling and human ADME to reduce time to clinic

Pharmaceutical Technology

The ADME study results form an important part of the Investigational New Drug (IND) approval process in the US and for the submission of a national Clinical Trial Authorization (CTA) in the EU. This has proved to be an extremely effective option for molecules where an understanding of absolute bioavailability is required.

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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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Cannabidiol milling: Selecting the right equipment for CBD testing

Pharmaceutical Technology

Just before the Covid-19 pandemic, there were 60 ongoing clinical trials with cannabis-based products, with the majority being tested for pain or psychosis. So far, the FDA has approved just one CBD product, a prescription drug designed to treat seizures associated with Lennox Gastaut syndrome (LGS) [i].