BioPharm International Editors

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.

Merck KGaA announces the completion of the acquisition of Sigma-Aldrich, a St. Louis-based life-sciences and technology company.

BioOutsource releases informational video detailing issues associated with ADCC assays and how to effectively analyze them.

The new executive director of the European Medicines Agency begins appointment.

FDA grants accelerated approval for Darzalex (daratumumab) for the treatment of multiple myeloma.

A new consortium involving Arecor, FUJIFILM Diosynth Biotechnologies and the Center for Process Innovation will focus on formulation innovation as a way to improve downstream processing and reduce biopharmaceutical cost.

High-dose axalimogene filolisbac immunotherapy will advance to expansion phase.

The University of Pittsburgh partners with biopharmaceutical company, Shire plc, to research rare diseases.

An ABPI report found a lack of quality candidates for high-skilled roles in areas such as bioinformatics, translational medicine, clinical pharmacology, and pathology.

As a result of the acquisition, Merck will have access to Harrisvaccine’s proprietary RNA Particle technology production platform.

FDA seeks feedback on possible analytical standards and approaches to optimize regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests.

A study and new index shows that only 65% of clinical trials are being registered and reported on. Nearly half of the new drugs approved by FDA in 2012 had one Phase II or III trial that was not disclosed. Regulatory ambiguities, mergers, and lack of enforcement action may be to blame

Connected Services program will link cGMP-manufacturing services with supply chain technology management solution.

The UK’s National Biologics Manufacturing Centre will use Novasep’s BioSC Lab for protein purification.

The European agency presents guidelines for conducting post-authorization efficacy studies.

GE Healthcare's KUBio prebuilt modules were shipped from Germany to JHL Biotech in Wuhan, China.

South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.

The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.

The novel antibody-engineering platform works differently than most of the currently employed antibody-modifying technologies, according to UM Baltimore.

ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.

USP responds to FDA's draft guidance on the naming of biological products.

The PRIME program is a drug development scheme to enable accelerated assessment of medications for conditions with unmet need.

The new committee will attempt to recruit regulatory professionals outside of existing ICH members to improve overall global pharmaceutical regulatory harmonization.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

Melanoma treatment, Imlygic, received a positive opinion from CHMP, and several other products received extension of indications.

The agency provides terms and recommendations for packaging and labeling of injectable medical products.

Biovest’s mAbVault provides supply-chain redundancy for antibodies that enables customers to lock in price-per-gram protein production.

Regeneron announced additional investments to its Limerick, Ireland biologics production facility.

The agency gives an update on the regulation of combination medical products.