BioPharm International Editors

The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.

The companies will work to co-develop FIN-524, a live biotherapeutic product composed of cultured bacteria strains.

Janssen will have access to PeptiDream’s proprietary Peptide Discovery Platform System technology, which will be used to identify peptides against multiple metabolic and cardiovascular targets.

Sartorius acquired the Swedish company that specializes in data analytics software for biopharmaceutical development and manufacturing.

EMA has developed a framework and action plan to foster relationships with the academic community.

The facility in Britley will now manufacture the company’s automated systems, enabling the company to better serve European markets and shorten the supply chain.

The Mobius MyWay portfolio offers off-the-shelf and configured-to-order single-use assemblies.

The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.

The company has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.

Permira will acquire LSNE, a CDMO for the pharmaceutical and medical device markets.

The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.

The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs

FDA approved avelumab for the treatment of patients with Merkel cell carcinoma.

The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.

The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.

The company has invested in a new pharmaceutical chemistry and microbiology facility in Scotland.

The companies will be expanding their collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.

Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.

The company announced that it would now be offering a portfolio of fresh and cryopreserved human and animal hepatocytes for ADME-Tox testing.

The company said that it has successfully completed its first in-orbit experiment using its miniature end-to-end space laboratory.

Human antibody for Zika virus could help in the treatment and prevention of the infection.

The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.

Under the agreement, Allergan will receive exclusive access to five of Editas’ ocular programs.

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.

The ready-to-fill packaging solutions for vials are based on Ompi EZ-fill packaging design.

The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.

The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.