Formulation and Drug Delivery

Samsung BioLogics Receives FDA Approval for Biologic Drug Substance Manufacturing

May 29, 2018

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

Novartis Gains EC Approval for Infliximab Biosimilar

May 29, 2018

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

Novartis’ AveXis to Invest $55 Million in New Gene Therapy Manufacturing Facility

May 25, 2018

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

FUJIFILM Adds Late-Phase and Commercial Fill/Finish Capabilities

May 24, 2018

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

Vectalys, FlashCell Merge to Form Gene Therapy Company

May 23, 2018

The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.

FDA Commissioner Puts Branded Companies on Notice

May 17, 2018

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

China’s Pharma Growth Potential to Drive Attendance at CPhI China

May 17, 2018

Internationalization and regulatory reform are driving growth and investment China.

FDA Approves Pfizer’s Epoetin Alfa Biosimilar

May 16, 2018

The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).

Cambrex Reports Expansions at its High Point, NC Facility

May 16, 2018

Cambrex Corporation has announced facility, equipment, and instrument upgrades at its High Point, NC facility and updated progress on expansions in Cedar City, IA.

GE Increases Cell Culture Media Production Capacity

May 16, 2018

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.