Formulation and Drug Delivery

Roche’s Ocrelizumab Granted Priority Review

June 28, 2016

The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.

EMA Recommends New High-Risk Blood Cancer Therapy

June 24, 2016

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

Study: HIV-1 Neutralizing Antibodies in Infants May Impact Vaccine Development

June 23, 2016

Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.

CAR-T Optimized to Target Solid Tumors in Animal Models

June 21, 2016

A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.

Janssen Alleges HyClone Lab Infringed its Cell-Culture Media Patent

June 17, 2016

In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.

Anthrax Vaccine Nabs Orphan Drug Status

June 16, 2016

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

Pfizer Builds Biologics Clinical Manufacturing Facility in Massachusetts

June 16, 2016

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

Hovione Breaks Ground on API Facility in New Jersey

June 16, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

Study: Patients Who Have Reactive Responses to Infliximab Should Not Switch to Biosimilar Versions

June 15, 2016

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.

FDA Approves Cholera Vaccine

June 13, 2016

FDA approved Vaxchora intended for travelers who are at risk for the disease.