Quality/GMPs

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

Highlights from a wide ranging discussion on COVID-19 pandemic response from Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, and Tom Madden, President & CEO at Acuitas Therapeutics.

Advanced analytical tools generate more data in today’s labs than ever before.

The program aims to aid submissions from external stakeholders and FDA staff.

Context surrounding the Inflation Reduction Act is necessary for a comprehensive understanding of the global biopharma market.

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

The guidance document outlines recommendations to limit potential carcinogenic risk.

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.

Pandemic, PBM, and other policies on hold during the summer recess.

Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.

The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.

The framework is now expanded beyond COVID-19 vaccines and treatments.

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

The new drug may help vulnerable children resist RSV in the coming fall and winter season.

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.

Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.

Problems continue despite actions by regulators to better prevent and address drug shortages.

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

The debate surrounding drug pricing changes rages on.

FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.

The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.