News

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.

Solutions to circumvent heterogenous mixtures of antibody-drug conjugates and to ensure uniform drug-to-antibody ratio were discussed at a recent Catalent Applied Drug Delivery Institute symposium.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Contract biopharmaceutical manufacturing has been growing steadily and is expected to reach $4.1 billion by 2019.

Although many immunotherapies focus on tumor-associated antigens, many of the peptide targets on the surface of cells have not be validated.

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

Researchers at the University of Pittsburgh say the compound may be more potent and selective than drugs currently available to treat epilepsy.

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.

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.

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.

A $1.1-million NSF grant awarded to Advanced Polymer Monitoring Technologies will be used for the development of a characterization technology for monitoring aggregation in biopharmaceuticals.

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.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

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 BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.

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.