News

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.

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

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

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

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 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.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

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.

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.

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

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

Sarepta sold the priority review voucher for Exondys 51, a controversial treatment for Duchenne Muscular Dystrophy, to Gilead.

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.

Metrohm USA presented the Young Chemist Award to Aldin Malkoc for his work on cooperative, DNA-based molecular elements for electrochemical biosensors.

The company expanded fill/finish services at its facility in Kalamazoo, Michigan.

The company opened a new bioconjugation unit to support the clinical and commercial manufacturing of ADCs.