Formulation and Drug Delivery

FDA Seizes Military Vaccine Used in Unauthorized Stem-Cell Treatments

August 28, 2017

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.

Alembic Sells Indian Formulations Plant

August 25, 2017

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

Genentech Gets Priority Review for Hemophilia A Biologic

August 24, 2017

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.

CPI Joins Consortium for Automated Continuous Biologics Purification

August 24, 2017

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

Samsung Bioepis Partners with Takeda to Develop Novel Biologics

August 21, 2017

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

Pfizer Gets FDA Approval for New Leukemia Drug

August 18, 2017

FDA approves new molecular entity developed by Pfizer for treating a rare form of leukemia in adults.

Biocon Withdraws Breast Cancer Biosimilar Filings in Europe

August 18, 2017

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

Smart Inhalers Improve Patient Compliance

August 16, 2017

Equipment and Processing Report

Sensors and communication capability support proper usage, improve compliance, and may enable telemedicine.

Regeneron Halts Development of RSV Biologic

August 15, 2017

The antibody therapeutic failed to meet its primary endpoint in a Phase III study.

Catalent Applied Drug Delivery Institute Appoints Jim Spavins to Advisory Board

August 15, 2017

Catalent Applied Drug Delivery Institute (CADDI) announced that Jim Spavins, a veteran pharmaceutical industry executive, has joined the institute’s advisory board.