Europe Publishes Electronic Product Information for Selected Medicines

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time. The European Medicines Agency (EMA) announced on Nov. 8, 2023 that the Heads of Medicines Agencies (HMA), the European Commission, and EMA have published electronic product information (ePI)

FDA Publishes Guidance on Container Closure Systems for COVID-19

The document includes recommendations for the reporting and implementation of changes to container closure system components. On Nov. 7, 2023, FDA issued final guidance that includes recommendations for reporting post-approval changes of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile

NASDAQ: PCRX - PDUFA date update

New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval

This is the second biologic approved to treat HS, a painful and reoccurring skin disease. On Oct 31, 2023, Novartis announced FDA’s approval of Cosentyx (secukinumab) as a treatment for adults with moderate to severe hidradenitis suppurativa (HS). As reported by Novartis, Cosentyx is the only FDA-approved fully human

European Commission Searches for Committee Experts

The EC is calling for interested parties for their safety and orphan drug committees. On Nov. 3, 2023, the European Commission announced it was launching a selection procedure for experts looking to join the European Medicines Agency’s (EMA’s) independent Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Orphan

ATCC and USP Launch Six Products Used to Detect Residual Host Cell Genomic DNA

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines. The US Pharmacopeia (USP) announced on Oct. 30, 2023, that ATCC and USP have collaborated to create a set of joint products to advance quality control of biological therapies and

TriLink BioTechnologies Launches Analytical Sciences Center of Excellence

The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing. TriLink BioTechnologies, a Maravai LifeSciences Company, announced on Nov. 2, 2023 that it has launched the Analytical Sciences Center of Excellence (ASCE). The new ASCE hub expands the company’s suite

Aragen to Establish $30 Million Biomanufacturing Facility in India

As part of a $30 million investment, Aragen is setting up a new biologics manufacturing facility in Bangalore, India. On Oct. 30, 2023, Aragen, a contract research development and manufacturing organization (CRDMO), announced that it was setting up a new biologics manufacturing facility in Bangalore, India as part of a

FDA Provides Guidance on Remote Facility Evaluations

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities. FDA released a draft guidance on Oct. 25, 2023, explaining the agency’s procedures for how it requests and conducts voluntary remote interactive evaluations at drug manufacturing facilities and facilities that