Bio/Pharma News

Sandoz Announces Acquisition of Pfizer’s Biosimilar Infliximab in European Economic Area

February 16, 2016

Sandoz reveals plans to complete a Phase III development program for Pfizer’s infliximab and file for registration in the EU.

Pfizer Announces Organizational Changes for Pending Allergan Merger

February 09, 2016

Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.

Celltrion’s Biosimilar to Remicade Likely to be Approved for All Indications

February 09, 2016

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

The Use of 2D-NMR for the Assessment of Biosimilarity

February 09, 2016

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.

Immunomedics Receives Breakthrough Therapy Designation for Breast Cancer Antibody-Drug Conjugate

February 08, 2016

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

Danish Companies and University Collaborate on MRSA Vaccine

February 08, 2016

Barvarian Nordic, Evaxion Biotech, and the Technical University of Denmark announced plans to collaborate on the development of a vaccine for MRSA.

FDA Staff Backs Remicade Biosimilar

February 08, 2016

FDA officials said on Feb. 5, 2016 that Celltrion’s biosimilar to infliximab was “highly similar” to Johnson & Johnson’s (J&J) Remicade, according to a report by Reuters.

Merck: Biosimilar Makers Likely to Target New Patients

February 04, 2016

Although switching has occurred in European markets for some biosimilars, most biosimilar manufacturers will focus on securing new users, according to Merck.

Sartorius Group Sales Revenue Jumps 16% in 2015

February 04, 2016

Sartorius releases financial results for 2015, announcing a 16% increase in group sales revenue.

ViaCyte Enters Clinical Trials for Type 1 Diabetes Treatment

February 04, 2016

ViaCyte and Janssen Biotech have entered Phase I/Phase II clinical trials for VC-01, a candidate treatment for the treatment of type 1 diabetes.