APIs and Excipients

Almac Group and Pila Pharma Sign Manufacturing Agreement

August 13, 2021

Almac Sciences has signed a manufacturing agreement with Pila Pharma for the production of the API XEN-D0501.

KGI Team Adapts Vaccine Development Work to Address COVID-19

August 12, 2021

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

FDA Approves AstraZeneca’s Lupus mAb, Saphnelo

August 03, 2021

FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

FDA Accepts Genentech’s Application for Bispecific Antibody to Treat Eye Diseases

August 03, 2021

FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.

EC Makes Supply Agreement with GSK and Vir Biotechnology for mAb COVID-19 Treatment

August 03, 2021

The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.

A Digital Supply Chain Helps Ensure API Quality

August 03, 2021

Data sharing facilitates traceability, transparency, and accuracy while driving efficiencies and boosting quality of active pharmaceutical ingredients.

Byondis and Glycotope Partner on Discovery and Development of Glyco-Epitope-Targeting Antibodies

July 29, 2021

Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.

Generate Life Sciences Establishes Newborn Stem Cell Manufacturing Facility

July 16, 2021

The GMP facility is designed to maximize bioprocessing efficiency of newborn stem cells and manufacturing at scale.

Continuus Pharmaceuticals Opens Process Development Lab

July 16, 2021

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

SPI Pharma Introduces Platform for Orally Disintegrating Tablets

July 12, 2021

UltraBurst has a high disintegration speed, which is for all market segments, from prescriptions to nutraceuticals.