Quality/GMPs

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.

The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.

The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.

The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.

Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.

FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.

A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to bio- pharmaceutical processes and systems.

The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.

Process understanding and careful assessment of risks are essential in developing viral clearance programs.

FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.

The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.