Quality Systems

There are many promising trials in the pipeline that may bring big news for major therapeutic areas.

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

The Centers for Medicare & Medicaid Services (CMS) has announced the first 10 drugs covered under Medicare Part D selected for negotiation.

Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) is approved as a first-line treatment for anemia in adults with lower-risk myelodysplastic syndromes.

The updated vaccine will be ready to ship following a positive European Commission review.

This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.

Adam Smith, a House of Representatives member representing Washington's 9th congressional district, discusses the state of U.S. healthcare and pharma.

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.

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.