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.

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.

The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.

President Trump calls for faster FDA approvals and lower drug prices.

Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.

The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.

The new company links and manages aspects of treatment delivery, facilitating access for patients to treatments by serving as a connector between manufacturers, patients, physicians, and payors.

FDA plans to initiate its quality metrics program as industry continues to push back.

Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

Thermo Fisher Scientific will provide cryo-TEM for small-molecule and biologic drug discovery.

The agency’s CHMP recommended six drugs for market approval, including one orphan drug, during its February meeting.

The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.