Quality Systems

Articles

Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.

Immodulon Gains Allowability of Claims for Key European Patent Application

Judith M. Sills, PharmD, is a nonexecutive director and advisor to Arriello—a provider of risk management and compliance services to the Life Sciences industry.

Eric Caugant is a nonexecutive director and advisor to Arriello—a provider of risk management and compliance services to the Life Sciences industry.

International pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.

Navigating International Pharmacovigilance

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.

The Facts About Filing Drug Applications

The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.

EMA Approves Use of Sotrovimab to Treat COVID-19

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

EMA Recommends Change in Storage Conditions for Pfizer/BioNTech Vaccine

Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.

Janssen Seeks European Approval of BCMA CAR-T Therapy

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

Decontamination, automation, and containment are important considerations
for aseptic manufacturing in isolators.


Understanding the Impact of Annex 1 on Isolator Operation

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

After Brexit there is an increased risk of the UK being exposed to counterfeit medicines, but regulations implementing blockchain as infrastructure technology could be the answer.

Blocking the Threat of Counterfeit Medicines

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.

NICE Issues Positive Recommendation for Use of Kineret to Treat Still’s Disease

EMA's CHMP has issued a positive opinion for Diurnal's second product in Europe, Chronocort (Efmody), to treat CAH.

Regulatory/GMP Compliance, Europe