BioPharm International Editors

Aurobindo has added four cell-culture derived biosimilars to its product line.

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.

The company announced results from a Phase II trial with its THC:CBD drug for the treatment of glioblastoma multiforme.

The companies entered into a license agreement for Immunomedic’s antibody-drug conjugate sacituzumab govitecan.

EMA announces that the European Union’s PAS Register has received its 1000th upload.

The company is voluntarily recalling product due to particulate matter.

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.

Companies were recognized for their innovative packaging technologies.

The company announced an investment in a new facility in Dundalk, County Louth, Ireland.

FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of cGMP for finished pharmaceuticals.

Novo Nordisk entered a research collaboration with the University of Oxford focused on Type 2 diabetes.

The £14-million research project aims to better understand adverse drug reactions through a variety of modeling approaches.

Local manufacturing, regulatory strategies, market entry, and harmonization to be featured at CPhI Istanbul.

Lek, a Sandoz company, adds capacity to its plant in Prevalje, Slovenia.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

ADMA will acquire BPC’s plasma-based fractionation and purification plant in Boca Raton, FL and plans to resolve issues at the facility noted in an FDA warning letter.

PAT, quality by design, process controls, and analytical advances for small- and large-molecule drugs are on agenda for IFPAC 2017.

The SCIEX PA 800 Plus Pharmaceutical Analysis system is used to identify and quantify glycans to ensure therapeutic efficacy.

The companies will split Actellion’s drug discovery and early-stage clinical development assets into a new Swiss biopharmaceutical company.

After a positive Phase II trial, the company said its C. difficile vaccine candidate will advance to Phase III trials during the first half of 2017.

The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

The organization launched its GOBOLDLY campaign to highlight the work of US biopharmaceutical companies.

WuXi AppTech acquired HD Biosciences, a preclinical drug-discovery-focused CRO.

The company released the Biopharma Compass 2.0 software, which automates workflows for high-resolution mass spectrometry.

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.