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Fujifilm to Invest Over 200 Billion yen (2 Billion USD) to Establish New Large-Scale Cell Culture Manufacturing Site for Biopharmaceuticals in the U.S.A.

The Pharma Data

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. TOKYO , Jan. Overview of New Site. ?Fill-finish

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

The Pharma Data

“By committing to bring biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are serving a critical need in expanding access to important medicines and fueling pharmaceutical innovation.”. The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL.

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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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Biopharma Money on the Move: December 2 – 8

The Pharma Data

The fully integrated pharmaceutical company creates value through China’s specialty pharmaceutical markets with focus on iron deficiency, pain management and respiratory. SciNeuro Pharmaceuticals . Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. Nuance Pharma .

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Q&A: The IND Journey Phase I – Navigating Success

Advarra

The sponsor is the pharmaceutical company conducting the trial. A: Working in a pharmaceutical company is the best way to learn this. A: This is a complex topic and is best outlined in the FDA’s guidance document. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting?

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Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

Alta Sciences

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses pmjackson Wed, 09/20/2023 - 13:48 Laval, Québec, September 21, 2023 - Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc. The final step for this program will be a bioanalytical sample analysis.

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FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

FDA Law Blog: Biosimilars

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.

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