News

The Alliance for Regenerative Medicine’s (ARM) report highlights major trends and metrics from the 2018 second quarter in the regenerative medicines sector.

Ebola vaccinations by the World Health Organization began in North Kivu, Democratic Republic of the Congo, one week after the country’s latest outbreak.

The combined companies will provide research- and clinical-grade human immune cells, blood products, and related services.

The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.

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.

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.

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.

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.