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STAT+: FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues

STAT

During an April 2023 inspection at Raptim facilites in Nava Mumbai, India, FDA inspectors found “objectionable conditions” that led them to conclude the company falsified data in testing for multiple subjects and samples across multiple studies, according to a letter sent last week to the pharmaceutical companies.

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The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing

Drug Patent Watch

The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48 from 2023 to 2030. As a result, many companies are turning to integrated CDMOs to simplify their outsourcing processes and improve efficiency. 2023, August 31). References Patheon.

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How CDMOs Can Help with Regulatory Challenges

Drug Patent Watch

By partnering with a CDMO, companies can benefit from these resources without having to invest in their own infrastructure. Collaborative Approach The regulatory process is inherently collaborative, and CDMOs work closely with pharmaceutical companies to navigate the regulatory pathway. 2023, November 17). 2023, June 23).

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Freyr Solutions.

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AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Express Pharma

In India, pharmaceutical companies responded to global environmental concerns and government mandates by adopting greener manufacturing techniques. Indian pharmaceutical companies have specialised in reverse-engineering complex medicines and producing biosimilars as alternatives to costly biologics.

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FDA approves 127 innovator and biosimilar drugs in 2024, marks shift in pharma approval landscape

Express Pharma

The US Food and Drug Administration (FDA) announced the approval of 127 innovator and biosimilar drugs in 2024, a notable decrease from the 149 approvals recorded in 2023.

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CNS innovator oligonucleotide licensing value surges by 339% to $2.8 billion in 2024, reveals GlobalData

Express Pharma

Innovator oligonucleotide-based drugs targeting central nervous system (CNS) disorders have seen a remarkable 339 per cent increase in licensing agreement deal value, rising from $640 million in 2023 to $2.81 However, Ionis Pharmaceuticals, leads the field with $13.4 billion in 2024, according to GlobalData.