Quality/GMPs

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

Three deaths attributed to acute liver failure appear to have occurred following regular treatment or investigational therapy.

Genascence’s first-in-class gene therapy blocking interleukin 1, GNSC-001, will enter a Phase IIb/III study in 2026.

The company’s gene therapy, AAVB-039, for the treatment of Stargardt disease progresses to a Phase I/II clinical trial.

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.

Linvoseltamab-gcpt, marketed as Lynozyfic, is a bispecific antibody designed to facilitate T cell activation and cancer cell killing.

EDQM is providing the 12th edition of the European Pharmacopoeia as an all-digital, redesigned, user-friendly issue.

The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).

Some of the companies that received American samples, FDA said, are partially owned or controlled by the Communist Party in China.

The company’s successful completion of facility and equipment qualifications gives it another biologics manufacturing option alongside its United States campus in Morgan Hill, Calif.

This paper highlights considerations based on risk that ensure ongoing success as well as improvement when applying cleaning and decontamination principles for biopharmaceutical cleanroom surfaces.

Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.

Biocon Biologics’ Yesintek demonstrated comparable safety and efficacy to the originator project, according to clinical data from a trial program.

Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.

The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.

Celltrion’s adalimumab-aaty is designated interchangeable as a high-concentration (100mg/mL) and citrate-free formulation of adalimumab.

Artificial intelligence will be a major component, FDA said, of the approaches the agency will be deploying to either reduce, refine, or potentially replace animal testing.

The agency has approved BMS’ Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.

The EMA has issued a new proposal that aims to encourage biosimilar development and improve patient access to biosimilar therapies.

This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

The shift toward personalized medicines poses new challenges in cleanroom protocols.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

Speaking at INTERPHEX 2025, William Wainwright, business development manager at Iwata Label USA, discusses the practical benefits of functional labels in protecting parenteral drugs.