Pharmaceutical Technology Editors

Tina Morris will be taking on the role of executive director for AAPS.

The facility will produce parenteral products and delivery devices and is set to create 460 new jobs.

Drug development contract services company PPD announces initial public offering.

The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.

Propess (dinoprostone) from Ferring Pharmaceuticals has achieved approval from the Minister of Health, Labour, and Welfare (MHLW) in Japan, making it the first pharmacological treatment for cervical ripening to be approved in the country for more than 20 years.

The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.

As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.

The new course is directed at analyzing the skills gap in the manufacture of cell and gene therapies as they progress toward manufacturing at scale.

The amount was the third highest year recorded and investment has increased more than 400% since 2012.

The drug treats adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity.

Fios Genomics, a spin-out bioinformatics company from Edinburgh University, has entered into a strategic partnership with Charles River Laboratories.

The new company will work to provide the manufacturing technologies and processes needed to develop and commercialize new cell and gene therapies through individual company products and expertise.

The fully integrated, pre-qualified, pre-installed aseptic filling facility can be shipped globally for drug development and the manufacturing of personalized medicines and clinical trial supplies.

The facility is now equipped to handle commercial manufacturing of a sterile injectable product in a pre-filled syringe presentation.

Frank Sorce will be taking on the role of regional business development director for Tedor Pharma.

FDA revised the guidance after industry feedback and to clarify CGMP requirements for outsourcing facility operations.

Mereo BioPharma Group and Oncologie have entered a global licensing agreement for the development and commercialization of navicixizumab.

The agreement centers around the development of new stem-cell derived allogeneic T-cell therapies for the treatment of cancer.

The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.

GE Healthcare Life Sciences’ new facility for cell and gene processing supplies will be open in 2022.

A development and manufacturing partnership with Thermo will allow Civica to expand its internal pipeline of medications for use in emergency and critical care in the United States, further preventing the risk of drug shortages.

By halting the withdrawal process, Civica could further its goal to stabilize the supply of generic medications and prevent drug shortages in the United States.

The UK’s MHRA has been recognized for its support of the development of an on-demand educational platform leveraging the power of virtual reality (VR), Virtuosi, from Quality Executive Partners (QxP).

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.

The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.

The next-generation gene editing system can be applied to the development of novel cell and gene therapies.

The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.

The renaming comes after the sale of Bosch Packaging Technology to CVC Capital Partners was completed on Jan. 2, 2020.

FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.

Karen Flynn rejoins Catalent as president of biologics operations; regional presidents named for US and Europe.