The first CPHI Middle East event will be held Dec. 10–12, 2024 at the Riyadh Front Exhibition & Convention Center Riyadh in Saudi Arabia and is expected to be host to 30,000 pharma professionals.

Centogene NV and ROPAD consortium publish data from a landmark study identifying genetic variants that may respond to innovative cell and gene therapies.

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.

Lilly is investing $3 billion to expand its recently acquired manufacturing facility in Wisconsin, while Amgen is investing $1 billion to expand its facility in North Carolina.

Through the agreement, Cambrex will provide accelerated access to clinical development capabilities to Lilly’s biotech collaborators.

The agency’s safety committee found no sufficient evidence of causal relationship between the antibiotic doxycycline and the risk of suicide or suicidal thoughts.

The European Commission has developed a roadmap aimed at reversing the rising trend of cancer across the European Union.

EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

With its new offering, Lonza can tailor services to support smart capsule companies with its bi-layer capsule manufacturing technology.

A new platform allowing market authorization holders to report drug shortages has gone live.

The 340B program is under greater scrutiny with more transparency for drug access being demanded by industry.

Aligned with our audience’s preferences, PTE will be a fully digital publication from 2025 onwards.

The acquisition will provide Roche with access to Poseida’s GMP manufacturing capabilities and R&D portfolio assets, including cell therapy candidates.

Through this acquisition, the German CDMO expands its global network and adds aseptic fill/finish and lyophilization expertise to its sterile manufacturing capabilities.

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

The Thousand Oaks, Calif., cell therapy manufacturing facility now houses new production suites, updated development labs, and more after expansion.

The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.

The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.

Sanofi will use this investment to increase its antibody bioproduction at its site in Lyon Gerland, France.

The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the new chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents

Located in German, Italy, and Lithuania, the new European facilities will specialize in drug discovery and R&D services.

SEKISUI has used a £15.7 million (US$20.7 million) investment to expand its clinical-grade drug substance manufacturing at its UK site.

Financing from OrbiMed, Novo Holdings, Jeito Capital, and others will enable Alentis Therapeutics to advance its pipeline of Claudin-1-targeted ADCs for treating solid tumors.

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

Frontier Scientific Solutions has unveiled plans to use a $1.5 billion commitment from a major investor to create a global free trade zone gateway to facilitate the life sciences supply chain using Wilmington International Airport in North Carolina.

CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.

Avantor's newly launched expanded Innovation Center in Bridgewater, NJ, is designed for integrated workflows and features purpose-built collaboration spaces.