Drug Development

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 seeks alternatives that meet the needs for next-gen biologic drug production.

With the right excipients, formulators can control when, where, and how an API is released.

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

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

The extension provides four additional process development laboratories at its Nottingham site to improve output and efficiency in drug development and clinical trial manufacturing operations.

WuXi STA supported the development of hepatitis drug through marketing authorization holder pilot program.

Intelligent manufacturing and environmental policies are key trends at P-MEC 2018.

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.

Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.

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

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

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.

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.

Cambrex invests $5 million in new laboratory expansion at its Karlskoga, Sweden facility.

Bosch Packaging Technology will introduce its newest R&D device for continuous oral solid dosage production at Achema 2018.

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

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 combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.

Allergan will buy a potential depression treatment from Aptinyx.

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.

ExcipientFest has been acquired by IPEC and rebranded as Excipient World.

Naturally occurring and engineered albumins are being explored as a tool to enhance the stability of drugs, including biologics, and extend shelf-life.