Drug Development

Articles

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

Eli Lilly to Invest $470 Million into New Pharma Manufacturing Facility

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.

Guidance Explains User Fee Structure for Biosimilars

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

GE Builds Single-Use Kit Manufacturing Facility in Switzerland

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. 

Thermo Fisher to Partner with Civica

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. 

Civica Looks to Take on Soon-To-Be Retired or Withdrawn ANDAs

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.

Nationwide Children’s Hospital Forms Gene Therapy Company, Andelyn Biosciences

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

Novavax Granted Fast Track Designation for NanoFlu in Older Adults

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.


2020 Outlook for Biopharma Manufacturing

Generic pharmaceutical company, Hikma Pharmaceuticals, and biopharmaceutical company, Arecor, have entered into an exclusive agreement for the development and commercialization of a ready-to-use injectable medicine.


Hikma, Arecor Enter Exclusive Agreement for Ready-to-Use Medicine

Under the agreement, Almirall will leverage WuXi Biologics’ proprietary WuXiBody platform to develop bispecific antibodies for dermatological diseases.

Formulation and Drug Delivery