Pharmaceutical Technology Editors

The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

The new 500-meter-square warehouse will hold incoming materials, including already micronized highly potent substances and cytotoxic products.

Cell and Gene Therapy Catapult and the Australian CRC for Cell Therapy Manufacturing to will collaborate on a project to test technology for T-cell stimulation and expansion.

The company will offer a standard serialization solution across 14 locations in Europe and more than 70 product lines.

Colorcon Acquired BASF’s Kollicoat IR Coating System product line, which includes currently customer business, and inventory.

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).

FDA cited BBT Biotech GMBH for failing to comply with current good manufacturing practice in its German API manufacturing facility.

The companies have launched VEGF 165, their first joint product for cell culture applications.

W.R. Grace & Co. will sell its chromatography product lines, which includes chromatography instruments, columns, and other related products.

Sanofi announced that it is making several changes to its executive committee, effective June 1, 2016.

The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.

Celgene will pay Agios $200 million to lead exploratory, research, drug discovery, and early development work for metabolic immuno-oncology.

The company recalls products due to sterility concerns.

The NIH and partners will launch a large-scale clinical trial in South Africa to evaluate the effectiveness of an HIV vaccine regimen

The agency detailed its 2015 achievements in an annual report.

The awards were presented at the AAPS Biotechnology Conference and included awards for ligand binding, innovation in biotechnology, and graduate student symposiums.

The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.

The companies entered into a commercial collaboration to develop web-enabled packaging for pharmaceutical and consumer goods companies.

Pfizer will acquire Anacor for $5.2 billion and expects the transaction to complete in the third-quarter of 2016.

Caribou announced the completion of a $30-million Series B financing round, which included the participation of new and current investors.

In a statement, Chip Davis, president and CEO of GPhA offers support of a study published in JAMA identifying opportunity for drug savings.

FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.

Pelican BioThermal, a provider of temperature-controlled packaging solutions for the life-sciences industry, announced on May 13, 2016 that it has entered into partnerships with BioThermal Solutions and NatBio, which offer cold chain logistics support in South America. Located in Sao Paulo, Brazil, NatBio was created to meet the demands of specialized clinics. BioThermal Solutions, based in Santiago, Chile, provides cold-chain maintenance solutions throughout Chile.

Combining powder micro-dosing services with the Xcelodose technology, Capsugel offers capabilities in both North America and Europe.

The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.

The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.

AMRI’s acquisition of Euticals expands its API development and manufacturing business.

Takeda received a $38 million grant from the Bill & Melinda Gates Foundation to develop, license, and supply Sabin-strain inactivated poliovirus to more than 70 developing countries.

The new facility will produce GMP film coating productions for the pharmaceutical and nutritional markets in South America.