Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.

Sotatercept, a drug candidate acquired by Merck in an $11.5 billion acquisition, showed statistically significant improvements in various measures.

Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

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.

EnteroBiotix is harnessing the power of the microbiome to target an array of diseases.

PAT is crucial to process control and real-time release in continuous manufacturing of solid-dosage drugs.

Technological advances will help ease pressure on pharma supply chains, allowing for greater visibility and less uncertainty.

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.

Soaring energy costs are compounding the challenges currently being faced by the European bio/pharma industry.

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

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

CHMP recommended the approval of AbbVie’s RINVOQ (upadacitinib) as a treatment for adults with moderate-to-severe Crohn’s disease.

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

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

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

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

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

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

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

AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.

The goal of this collaboration is to develop an approach to personalized radiotherapy and drug discovery that is based in genomics and artificial intelligence.

GAO calls for more oversight of institutional review boards in clinical trials.

This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.

Agilent’s therapeutic nucleic acids facility gains architectural design support from CRB.

Pfizer reports that the combination of talazoparib and enzalutamide demonstrated statistically significant improvement in patient survival in a Phase III trial.

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.