All News

FDA has an official new leader, following a Senate vote to confirm Stephen Hahn as the agency’s next commissioner.

Under the restructuring, Sanofi will gain sole global rights to Kevzara (sarilumab) and sole ex-US rights to Praluent (alirocumab), while Regeneron will gain sole US rights to Praluent.

The biologic is a novel bone builder that has a dual effect of increasing bone formation and reducing bone loss.

GE Healthcare Life Sciences and Advanced Solutions Life Sciences (ASLS) are partnering on 3D-printing of tissues that can be used for discovery and cytotoxicity testing.

The expansion will enhance the company’s specialty drug product capabilities.

The new technical service center at the Memphis International Airport will service inbound and outbound traffic for the company’s CSafe RKN and CSafe RAP active container systems.

The new Technology Excellence Center, located in Boston, MA, will further the company’s presence in the United States biopharma drug development landscape.

The new software lets users choose the volume and cell concentration from initial cell preparation through transduction to final resuspension, without compromising cell viability and virus stability.

The latest advances in upstream technologies include single-use equipment and a protein analyzer for titer monitoring, as well as new plasmid DNA manufacturing capability.

The app, CURE ID, is designed to allow the clinical community to report their experiences treating infectious diseases with novel uses of existing FDA-approved drugs.

Expert poll highlights strength of US pharma sector and advances by emerging markets.

GE Healthcare Life Sciences and Guangzhou Development District Investment Promotion Bureau have signed an agreement to jointly establish a training center for biopharmaceutical professionals.

BioMed X has announced the successful completion of its first joint research project in the fields of COPD and IPF that it had undertaken with Boehringer Ingelheim.

CPI has partnered with ImmunoBiology (ImmBio) for the development of a heat-stabilized formulation of a mutli-antigen vaccine candidate against Pneumococcal diseases.

Data released by the Cell and Gene Therapy Catapult (CGT Catapult) have shown that demands for specialist skills and investment in the cell and gene therapy industry in the United Kingdom are set to increase in the near future.

Iontas has entered into a collaboration agreement with Adaptate Biotherapeutics for the generation and optimization of antibodies for novel immune-oncology targets.

Horizon Discovery has announced its partnership with the Human Protein Atlas, which will see the incorporation of Horizon’s CRISPR-edited knockout cell models into the Cell Atlas program.

The new 50,000-square-foot facility will create 200 new jobs and accelerate commercialization of gene and cell therapies.

The acquisition aids in the expansion of the Astellas Focus Area approach, which involves the creation of medicines for diseases with high unmet medical needs by identifying combinations of biology, therapeutic modality and technology based on emerging science.

A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.

Through the program, the company will introduce seven new manufacturing sites that will be completed and operational by the end of 2020.

Biopharma company, Zelluna Immunotherapy, and clinical stage biotech, Glycostem Therapeutics, have entered into a partnership focused on the development and manufacture of allogeneic T-cell receptor guided Natural Killer cell therapies for the treatment of cancer.

The companies announced a commercial supply agreement following FDA’s accelerated approval.

The acquisition of The Medicines Company and its investigational cholesterol-lowering therapy extends Novartis’ cardiovascular pipeline.

Lubrizol Life Science Health adopts new name and opens commercial manufacturing facility.

New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.

BASF launches digital solutions for the pharma industry during CPhI Worldwide 2019.

Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.

West introduced NovaPure 3-mL Cartridge components and the SmartDose Gen. II 10-mL injector.

Schott and W.L. Gore introduced a prefillable, silicone-free glass syringe system, which won an award at CPhI Worldwide.