Quality/GMPs

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.

The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.

Processes, people, and tools are necessary to comply with the pharmacopoeia and approved drug product registrations.

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.

FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.

BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.

EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

A new FDA guidance provides answers to such questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).