BioPharm International Editors

Researchers discovered more than 300 antibodies that reacted with the Ebola virus’s surface glycoprotein and could be used to neutralize many strains of the virus.

AAIPharma/Cambridge Major Labs plans to invest $10.7 million to relocate the company’s analytical testing facility to the Cortex Innovation Center in Missouri.

The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.

The company issues a voluntary recall of a lot of 0.9% sodium chloride solution due to particulate matter.

The directorate is looking for experts to join the European Pharmacopoeia network.

Recipharm plans to invest €40 million in the project as a result of EMA decision to make serialization of licensed drug products a legal requirement by 2019.

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

Unchained Labs acquires Freeslate, marking the company’s fourth acquisition in the past 12 months.

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

The collaboration will allow the companies to develop and manufacture novel inhaled therapeutics.

This marks Vetter’s fourth internationally recognized award for its syringe closure system, Vetter-Ject.

Growth in finished dosage formulations triggers a new CPhI Worldwide event.

Wyeth reaches agreement in principle to resolve Medicaid drug rebate claims for 2001-2006 period for Protonix.

Sartorius announced the release of the company’s new Tacta pipettes.

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

GRAM completed a fourth FDA inspection of its parenteral manufacturing facility with no Form 483 observation issues.

Metrohm USA awards the 2016 Young Chemist Award to PhD candidate developing wearable sensors that can non-invasively monitor physiologically relevant chemicals.

3M Drug Delivery Systems, Ei Solutionworks, IDT Biologika join CMO/CDMO association

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

The agency prepares a plan to implement new packaging safety features.

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

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

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

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.

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

LabConnect built a biorepository facility in Tennessee.

AstraZeneca received conditional marketing authorization for Tagrisso, a tablet for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer.

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.

Pfizer and Bristol-Myers Squibb enter into agreement with Portola to develop and commercialize andexanet alfa in Japan.