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A study shows high levels of ADAs to infliximab at the beginning of treatment were associated with a poor response later on.

Celltrion Plans to Develop Tests to Determine ADA Levels in Blood

The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.

Ibrutinib Receives Orphan Drug and Breakthrough Therapy Designation for cGVHD

Mayne entered into an agreement with Teva and Allergan to acquire 37 approved and 5 FDA-filed products.

Mayne Pharma to Acquire US Generics Product Portfolio from Teva and Allergan

The facility will be built in approximately 18 months using GE Healthcare’s KUBio modular facility solution.

Pfizer Builds Biotechnology Facility in China

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

Roche’s Ocrelizumab Granted Priority Review

The companies agree to exchange ownership of Sanofi’s animal health and Boehringer Ingelheim’s consumer healthcare businesses.

Sanofi and Boehringer-Ingelheim Sign on Business Unit Swaps

Langer will work with the company to develop its portfolio of cannabidiol candidates for bone health.

Kalytera Appoints Robert Langer to Scientific Advisory Board

The 10-year agreement augments Adaptimmune’s license and supply relationship with Thermo Fisher for the Dynabeads CD3/CD28 Cell Therapy System for use in the manufacture of Adaptimmune’s SPEAR T-cell therapies.

Adaptimmune and Thermo Fisher Collaborate on Manufacture of Cell Therapies

Pending regulatory approval, Sandoz plans to release biosimilars to etanercept, adalimumab, pegfilgrastim, infliximab, and rituximab.

Sandoz Plans to Launch Five Biosimilars by 2020

Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.

Bio/Pharma News