Quality Systems

FDA has approved a new mAb therapy from Regeneron Pharmaceuticals as well as a higher dose version of Eylea, the company’s eye disease therapeutic.

The immunization, meant to protect infants aged six months or lower, is given to pregnant individuals at a gestation period of 32 to 36 weeks.

Ipsen’s Sohonos (palovarotene) capsules are designed to reduce new, abnormal bone formation in soft and connective tissues in individuals with fibrodysplasia ossificans progressiva, a rare bone disease.

FDA has halted enrollment in clinical studies for Gilead Sciences’ magrolimab, a biologic treatment in development for acute myeloid leukemia.

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.

The indication for Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).

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.

The new drug could be a powerful tool for patients suffering depressive symptoms after birth.

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.

The investigational drug was developed to activate a novel uptake pathway, allowing antineoplastic drugs to combat solid tumors more successfully.

Lower levels of an active ingredient may result in unexpected pregnancies.

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

The industry is taking steps to automate the final product inspection process for complex therapeutics.

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

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

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

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

Environmental monitoring data can help keep sterile environments sterile.

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

The guidance document outlines recommendations to limit potential carcinogenic risk.

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

Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solutions) is designed to treat Demodex blepharitis by directly targeting Demodex mites.

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.

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

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