BioPharm International Editors


FDA Issues Guidance on Potency for mAbs and Therapeutic Proteins

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.

Eli Lilly to Cap Out-Of-Pocket Insulin Costs at $35

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

AstraZeneca Strikes $1.16 Billion Licensing Deal for Gastric Cancer Candidate

AstraZeneca has entered into a global exclusive license agreement with KYM Biosciences for CMG901, which is being investigated as a gastric cancer treatment.

Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.

WHO Calls for Increased Funding to Aid Yemen’s Health Crisis

WHO is appealing for US $392 million to reach 12.9 million people with essential health assistance in 2023.

Orchard Therapeutics to Reimburse Access to Libmeldy for MLD Patients in Sweden

Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.

Bio-Rad’s New StarBright Blue and Yellow Dyes Enhance Multiplex Flow Cytometry

Bio-Rad’s newly launched StarBright Blue and StarBright Yellow dyes are intended for use in various flow cytometry applications.

Eurofins Viracor Launches Test for Assessing Expansion and Persistence of CAR-T Therapy in Cancer Patients

Eurofins Viracor ExPeCT CAR-T qPCR assay is a tool designed for monitoring and optimizating CAR-T therapies.

Moderna and Life Edit Therapeutics Enter Gene Editing Collaboration

Moderna will leverage Life Edit’s suite of gene editing technologies to advance development of in vivo gene editing therapies.

FDA Approves Sanofi Hemophilia Treatment

Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.