BioPharm International Editors

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

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

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

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 agency detailed its 2015 achievements in an annual report.

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

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.

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.

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.

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.

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.

Phase I clinical trials of PfSPZ revealed it may protect healthy adults, who have not been exposed to Malaria before, for more than on year.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

FUJIFILM Diosynth Biotechnologies Opens New Laboratory Facility in Research Triangle Park, NC.

The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.

Under the terms of an agreement with Pfizer, WAVE will advance up to five programs from discovery through the selection of clinical candidates.

CPhI China is expected to bring together approximately 35,000 attendees from more than 120 countries worldwide.

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

Progress is being made, but work remains to be done. Brian Daleiden, vice president of marketing at TraceLink, discusses the state of the industry, as companies attempt to meet complex, and changing, global requirements.

The companies have agreed to an all-stock merger of equals transaction anticipated to close in the second half of 2016.

The collaborations have the goal of creating new tools that will help predict how people with Type 2 diabetes adhere to their medication.

MilliporeSigma, the North American life-sciences business of Germany’s Merck KGaA, added a 2000-L single-use bioreactor to its facility in Massachusetts.

EMD Serono, the North American biopharmaceutical business of Germany’s Merck KGaA, will expand its R&D facility in Massachusetts, US.

The agency extends the indication of the drug in combination with bendamustine.

The agency holds a workshop to strengthen collaboration with healthcare providers.