Development

FDA and ICH seek comment on new exposure levels for cadmium in drug products.

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Sanofi will open a R&D operations hub in Chengdu, Sichuan province, China, with a focus on digitalization and big data analysis.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

MilliporeSigma targets emerging biotechs with US development center and global grants.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

Vetter anounced the Open Innovation Challenge to examine the applicability of digital trends to injection systems.

Lonza has added four liver cell types to its hepatocytes portfolio for testing of in vitro drug models.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

FUJIFILM Diosynth Biotechnologies opens Cambridge, MA center to promote collaboration with biotech companies.

By minding gaps in industry knowledge, bio/pharma companies can avoid development pitfalls.

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.