Quality/GMPs

The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.

Preparation is key for remote vendor and contract partner audits.

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.

The EC’s approval of GSK’s Benlysta (belimumab) marks the first and only biologic approved for both systemic lupus erythematosus and lupus nephritis.

The European Commission has approved an additional indication for Roche’s Tecentriq (atezolizumab) as a first-line monotherapy treatment for metastatic non-small cell lung cancer.

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.

Combating COVID-19 is bolstering efforts to limit patent protections on innovative medicines and vaccines.

ISPE’s virtual events will center around the sustainable implementation of and shared responsibility for quality risk management, while providing a space for regulators and industry leaders to share lessons and maintain transparency.

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

A best practices approach to pharma’s most challenging-to-inspect container.

Bio/pharma can learn ways to prevent recurring events and ineffective CAPA from the nuclear power sector.

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.

Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.

FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

The adoption of single-use technologies in fluid-handling systems helps streamline downstream bioprocessing operations.

Dynamic light scattering presents a good analytical technique for testing protein stability.

Scrutiny of the vulnerability in the biopharmaceutical supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.

NICE has issued a positive recommendation for Sobi's Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.

Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.