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Breakthrough drug candidates and cancer treatment innovations

Drug Target Review

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

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Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

The Pharma Data

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe.

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Janssen Announces U.S. FDA Approval of INVEGA HAFYERA™ (6-month paliperidone.

The Pharma Data

Approval is backed by nearly two decades of proven efficacy and safety of Janssen’s long-acting injectable portfolio of schizophrenia medicines. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. 1 Study evaluations included efficacy, safety, pharmacokinetics, and pharmacodynamics.

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Eplontersen

New Drug Approvals

1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] 2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] Ionis Pharmaceuticals. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. 7 March 2023.

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Advanced 3D cell-based technologies

Drug Target Review

The International Consortium for Innovation and Quality in Pharmaceutical Development has published guidelines to qualify as a valid model for specific organ-chip applications. These guidelines drive the legitimacy of the models towards regulatory approval.

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Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

The Premier Consulting Blog

Even for repurposed drugs being developed under the 505(b)(2) New Drug Application (NDA) pathway, it is critical to review the existing nonclinical and clinical data on the drug to determine what nonclinical studies may be beneficial to conduct prior to the PIND meeting and include this information in the package.

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Improving Drug Safety Through Cardiotoxicity Assessment

PerkinElmer

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. link] New safety concerns identified for 1 in 3 FDA-approved drugs [Internet].

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