Quality/GMPs

EMA’s CHMP recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma.

FDA has accepted Sanofi’s sBLA for the mAb and granted it priority review status for the targeted treatment of bullous pemphigoid.

Compliance and competitiveness are key factors in aseptic processing, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Artificial intelligence, among other technological advances, is pushing innovation boundaries.

The approval provides greater access to insulin treatment options.

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

Avtozma references Roche’s tocilizumab offering and has also shown promise as a treatment for CAR-T cell-induced cytokine release syndrome as well as COVID-19.

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

Vimkunya was granted approval under priority review based on positive results from two Phase III trials.

Ospomyv, or Obodence in the EU, and Xbryk were approved for all indications referencing Prolia and Xgeva, respectively.

This expanded label allows IZERVAY (avacincaptad pegol intravitreal solution) to be used without a limitation on duration of dosing for treating geographic atrophy.

The vaccine combines the antigenic components of two previously well-established meningococcal vaccines made by GSK.

The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.

The company plans to assess alternate payloads for its gene therapy program, which will shift its timeline.

Personalized medicine is a trend that continues to impact innovation and business decisions in the biopharma industry.

On the back of FDA’s designation, March Biosciences is preparing to advance MB-105, a CD5-targeted CAR-T cell therapy, to a Phase II clinical trial in early 2025.

The approval makes Susvimo the first and only continuous delivery treatment for diabetic macular edema.

The committee’s recommendation was based on results from a Phase III trial that demonstrated a 27% reduction in the risk of death versus placebo.

AI regulations in healthcare are rapidly evolving, and one should consult with regulatory subject matter experts, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

The UK MHRA has granted approval for garadacimab for use in preventing angioedema attacks in patients 12 years old and older who have hereditary angioedema.

The approval makes Enhertu (fam-trastuzumab deruxtecan-nxki) the first HER2-directed therapy in the United States for treating HER2-low or HER2-ultralow metastatic breast cancer.

FDA has approved an additional indication for LEQEMBI (lecanemab-irmb) as a once-every-four-weeks maintenance therapy for early Alzheimer’s disease.

This latest fast track designation marks the second such designation by FDA for J&J’s tau-directed investigational therapies for treating Alzheimer’s disease.

The approval makes HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] the first and only facilitated subcutaneous immunoglobulin to be approved in Japan to treat these disorders.

FDA provides recommendations for those interested in participating in the agency's Advanced Manufacturing Technologies Designation Program.

FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.

The approval of Hikma Pharmaceuticals’ liraglutide injection marks the first generic version of Victoza, a GLP-1 receptor agonist.

EMA and HMA have published revised guidelines on identification of commercially confidential information and personal data used in marketing authorization applications.