News

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.

Typical single-use bags and materials cannot withstand a large range of temperatures. Many of the items on the market are associated with extractables that can leach into bioprocessing fluids-an issue that has recently been a topic of conversation among groups that seek to standardize single-use systems, such as the BioPhorum Operations Group (BPOG) and the Bio-Process Systems Alliance (BPSA).

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.

MSD joined the WHO campaign in Africa, which is focused on staying polio free.

AbbVie will acquire Stemcentrx and its lead late-stage asset rovalpituzumab tesirine (Rova-T), a novel biomarker-specific therapy derived from cancer stem cells.

The company voluntarily recalls product due to particulate matter.

The company announced the launch of its first-in-class Lynx CDR connectors at INTERPHEX 2016.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

The Subcommittee for Advanced Manufacturing of the National Science and Technology Council highlights biopharmaceutical manufacturing as an emerging priority.

WHO report highlights goal of eliminating malaria in 35 countries by 2030.

Plasticell was recognized for its contribution to the advancement of regenerative medicine, cell and gene therapy, as well as other areas of biomedical research.

Pfizer announced the launch of Pfizer CentreOne, a CMO formed by the combination of Pfizer CentreSource and Hospira One 2 One.

Traditional methods of measuring the effectiveness of vaccines against the flu are called into question by new findings from the NIH.

The National Institutes of Health (NIH) released a statement on April 19, 2016 saying that it plans to suspend research in two laboratories after preliminary results found the labs not in compliance with CGMP practices.

Extract Technology’s portfolio will now include aseptic solutions, containment solutions, restricted access barriers, and mobile cleanrooms for the pharmaceutical, healthcare, biotech and chemical markets.

The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.

Sanofi will invest in its Geel, Belgium facility in order to support its pipeline of monoclonal antibodies.