Pharmaceutical Technology Editors

FDA approved avelumab for the treatment of patients with Merkel cell carcinoma.

The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.

Fisher BioServices will expand its CryoHub solution by co-locating it with the Cell and Gene Therapy Catapult manufacturing center for seamless supply chain management and to accelerate cell and gene therapy production.

The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.

The company has invested in a new pharmaceutical chemistry and microbiology facility in Scotland.

The companies will be expanding their collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.

Aptar Pharma’s newly-expanded site will be used to complete premium injectable elastomeric component manufacturing.

Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.

The company announced that it would now be offering a portfolio of fresh and cryopreserved human and animal hepatocytes for ADME-Tox testing.

The company said that it has successfully completed its first in-orbit experiment using its miniature end-to-end space laboratory.

Excipient manufacturer adds three tablet binding and disintegration products.

FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.

The company is switching to a more powerful and energy-efficient technology at its production site in Pfreimd, Germany.

Manufacturing will be carried out at the Pfizer Newbridge, Ireland, facility, which is now part of Pfizer CentreOne’s contract manufacturing network.

Human antibody for Zika virus could help in the treatment and prevention of the infection.

The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.

Known as the Fast Series, the company’s new line of preconfigured track-and-trace products are designed to help pharmaceutical companies comply with serialization requirements fast.

Under the agreement, Allergan will receive exclusive access to five of Editas’ ocular programs.

QF20kSU single-use pumps from Quattroflow are used for applications requiring gentle product handling, high containment, low pulsation, purity, and cleanability.

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.

The ready-to-fill packaging solutions for vials are based on Ompi EZ-fill packaging design.

The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.

The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.

The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.

The company made a €42 million investment in a new building at its Reinbek site to support the production of biopharmaceuticals.

Dr. Janet Woodcock said implementation of Informatics Process Management is a priority during the latest Director’s Corner podcast.

The companies have entered into an agreement to develop and commercialize a mAb for the prevention of lower respiratory tract illness in young children.

BeiGene and the Guangzhou Development District have established a joint venture to build a biologics manufacturing facility in China.