
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 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.

Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.

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 White House said President Trump will nominate Scott Gottlieb to the position of FDA commissioner.

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

Senator Chuck Grassley sent a letter to the Kaléo CEO questioning the drugs high listing price.

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.

A blog posted on Health Affairs on March 7, 2017 presents a study that tested PhRMA’s long-standing argument that high prices for drugs fund research and development in the pharmaceutical industry.

The conference will include 55 speakers at more than 44 sessions.

The innovations-oriented Think Tank combines academic-scientific and technical expertise to use Shimadzu’s expertise to provide even more customer-focused service.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

A new software technology, CRISPETa, is designed to assist in the deletion of non-protein coding sections of DNA.

Drug type, potential sales, and ownership factor in the race to get drugs to market.