BioPharm International Editors

The company announced that it received EXCiPACT certification in December 2015.

The company received a positive recommendation for it’s Remicade biosimilar, Flixabi (infliximab).

Sandoz Industrial Products GmbH will be renamed Corden BioChem and will be associated with the CordenPharma Group, ICIG’s pharmaceutical platform.

The companies will merge to create a gene therapy biologics CDMO.

The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.

The service center will act as a hub for delivery, maintenance, calibration, and technical support for the company.

The companies will provide assays for functional comparability, for use in quality control, lot release, and stability testing of biosimilars and biobetters.

The new research scheme will be based in GE’s Turkey-based innovation center, and will help support the region’s biopharmaceutical industry.

The commercial partnership aims to use digital health tools including sensors, apps, analytics, personal feedback, and education to assist patients in monitoring respiratory diseases.

Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.

The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.

The report examines the increased number of companies cited by regulators for data integrity issues.

A team of Bristol-Myers Squibb scientists will work in a new laboratory at the National Institute of Bioprocessing Research and Training facility in Dublin, Ireland.

Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.

A new 3D modeling and data-extraction technique Improves X-ray crystallography analysis of proteins.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

The company broke ground on a $79 million production facility at its Ravensburg Schuetzenstrasse site.

The partnership aims to facilitate the development of therapeutic and diagnostic candidates for European biopharmaceutical clients.

Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.

The conference discussed key industry issues including serialization, innovation, and patient-centricity.

The Human Vaccines Project brings together academic research centers, industrial partners, nonprofit organizations, and governments to address the primary scientific barriers to developing new vaccines and immunotherapies.

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.

The agency now allows production of water for injection by non-distillation technologies.

The new class of mAbs differs from approved anti-PD 1 mAbs because they do not block the PD-1-PD-L1 interaction.

The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar its reference product.

The agency cited Emcure Pharmaceuticals with CGMP violations.

The merger creates a provider of sample prep, synthesis, and bioanalytical tools for biotherapeutics discovery, development, and manufacturing.

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

Kovaltry is an unmodified, full-length recombinant factor VII product used to treat hemophilia A in adults and children.