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Orphagen’s ACC therapy receives FDA rare pediatric disease status

Pharmaceutical Technology

OR-449 is a first-in-class, orally bioavailable, potent and selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1). SF-1 is an important transcription factor for adrenal gland growth and development.

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Erasca receives fast track designation for glioblastoma therapy

Pharmaceutical Technology

The orally bioavailable small molecule EGFR inhibitor ERAS-801 demonstrated significant central nervous system (CNS) penetration in animal trials. This newly granted status helps Erasca to facilitate the development and review of ERAS-801, thereby accelerating the therapy’s reach to patients.

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Zerion and Insud to develop Dispersome formulations of drugs

Pharmaceutical Technology

Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs. The finished product dosage form, clinical development and the final products’ marketing and sales across the globe will be handled by Insud. . All the clinical and other development expenses will be handled by Insud.

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Drug developers look at innovative mechanisms to tackle dry eye syndrome

Pharmaceutical Technology

cyclosporine A) is currently at pre-registration stage with the FDA, following results from late-stage clinical trials that demonstrated CyclASol significantly reduced corneal and conjunctival staining, and improved ocular dryness compared with vehicle. Novaliq’s CyclASol (0.1%

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Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Trials 69
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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Dosing is not left up to physicians; it is built into the FDC product and based on clinical trial results. Furthermore, compared to the cost of developing a new API, substantial savings can be realised when developing an FDC comprised of previously approved new chemical entities or their generic counterparts.

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Strategies for Streamlining Small Molecule Formulation Development When Bridging from Candidate Selection to First-in-Human Clinical Testing

Pharmaceutical Technology

By associating molecular properties with in-silico absorption, distribution, metabolism, excretion, and toxicity (ADMET) models, we can significantly increase the robustness of candidate selection, which subsequently reduces the failure rate during clinical trials.