Drug Development

Articles

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

FDA Publishes User Fee Guidance

The approval is intended to increase patient access to treatment for opioid addiction.

FDA Approves Generic Suboxone Sublingual Film for Opioid Dependence Treatment

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

Sanofi Pasteur, Translate Bio in $805-Million Deal to Develop mRNA-Based Vaccines

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

US and EU Talk Inspections, Generics, and Advanced Therapies at Bilateral Meeting

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Canada OKs Samsung BioLogics’ mAb Drug Substance Plant

The company has resubmitted a biologics license application to FDA for its proposed biosimilar to Roche’s Herceptin.

Celltrion Resubmits to FDA Its Proposed Biosimilar to Roche’s Herceptin

The extension provides four additional process development laboratories at its Nottingham site to improve output and efficiency in drug development and clinical trial manufacturing operations.

Juniper Pharma Services Expands Laboratory Facilities

WuXi STA supported the development of hepatitis drug through marketing authorization holder pilot program.

CFDA Approves Drug Developed with CDMO Support

Intelligent manufacturing and environmental policies are key trends at P-MEC 2018.

Domestic Pharma Industry Drives Machinery Demands at P-MEC China

Microbiologists from the University of Connecticut have pinpointed exterior proteins on syphilis-causing bacteria that could serve as vaccine targets for syphilis.

Formulation and Drug Delivery