Industry News

Looking at the role that RSV and pediatric medical practices play in drug shortages.

The largest biotech hub is set to be built in Lithuania by Northway Group.

UK industry body, ABPI, has responded positively to the recent Autumn Statement.

Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.

The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.

Andy Geall, co-founder and chief development officer at Replicate Bioscience continues the discussion on the development history of mRNA therapeutics.

Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

Andy Geall, co-founder and chief development officer at Replicate Bioscience, discusses the historical context and buildup of the mRNA therapeutics field.

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

The document includes recommendations for the reporting and implementation of changes to container closure system components.

Chris Spivey, editorial director for Pharmaceutical Technology®, discusses mRNA advances and the background for the leading scientific conference for the field, with host and co-organizer CureVac CEO Dr. Alexander Zehnder.

The Alliance for mRNA Medicines (AMM) was officially launched at the 11th International mRNA Health Conference in Berlin, Germany.

The EC is calling for interested parties for their safety and orphan drug committees.

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

Pharmaceutical Technology Europe® spoke with Dr. Tom Kamperman from IamFluidics, a Dutch high-tech company that develops customized microencapsulation solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

Pharmaceutical Technology Europe® spoke with Dr. Rainer Schmidt from Galvita AG, an excipient manufacturer based in Switzerland, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

A recent AAPS Salary Survey shows a rising trend in compensation for pharmaceutical scientists since 2022.

As CMOs continue to invest in cell culture capacity, some are expected to surpass top in-house companies.

The winners of the 2023 CPHI Pharma Awards were announced on October 25 at the CPHI Barcelona event.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

The report indicates a rise in biotech funding and subsequent growth for pharma contract services.

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.

The agency is warning patients and healthcare providers about pre-filled pens falsely labeled as Ozempic.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.

The draft guidance document discusses quality considerations for topical ophthalmic drug products.

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

The program will improve access to adeno-associated virus gene therapy vectors.