The European Commission (EC) approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin, to treat certain breast and gastric cancers.

Leistritz’s Twin Screw Extrusion Workshop, taking place Nov. 28–29, 2018 in Clifton and Somerville, NJ, will feature classroom sessions and extrusion demonstrations.

The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.

Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.

AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.

The companies will collaborate to bring InnoCore Pharmaceuticals’ proprietary SynBiosys biodegradable polymer platform to market.

Researchers at the University of Pennsylvania found that diabetes drugs called thiazolidinediones can promote the metabolism of glutamine to help control disease-causing inflammation.

Stem-cell developer TiGenix has been acquired by Takeda Pharmaceutical for approximately EUR 520 million (US$604 million).

The company broke ground on its $200-million, 120,000-ft2 biomanufacturing plant in West Greenwich, RI.

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.

The acquisition will increase Metrohm’s spectroscopy offerings and capabilities.

GlaxoSmithKline and 23andMe, a personal genomics and biotechnology company, will partner to research and develop new drugs using human genetics.

The companies will work together to develop novel gamma delta T-cell receptor therapies in various cancers.

CMOs have been active over the past year in expanding their biologics production and capabilities.

This article provides a sampling of the latest investments, expansions, and acquisitions by small-molecule contract service providers.

Novartis is set to partner with MorphoSys and Galapagos in a deal worth up to $1.1 billion to develop and commercialize their joint investigational, fully human, IgG1 monoclonal antibody (mAb) directed against the target IL-17C.

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.

The recommended drugs include two orphan medicines and three biosimilars.

The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.

Waters’ acquisition of Prosolia’s DESI technology boosts its mass spectrometry imaging portfolio.

Quartzy, an online laboratory supply management company, will offer lab products from Bioline, Biotium, and MP Biomedicals.

The Omnis KF is fully integrated solution for moisture analysis and water content determination with volumetric Karl Fischer titration.

The acquisition would combine Sangamo’s ex vivo gene-editing capabilities with TxCell's regulatory T-cell (Treg) expertise to create chimeric antigen receptor (CAR)-Treg therapies.

Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.

The API and drug product provider will invest £375,000 (US$493,000) in additional nuclear magnetic resonance (NMR) instrumentation at its headquarters in Craigavon, UK.

The glass and chemical provider will expand its synthetic pharmaceutical intermediate and API production capacity at its plant in Chiba, Japan.