News

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.

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

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.

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

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

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.

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

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.

Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.

The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

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

Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.

AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.