Quality/GMPs

The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.

GlaxoSmithKline and Vir Biotechnology have received a conditional marketing authorization from MHRA for Xevudy (sotrovimab) in the treatment of COVID-19.

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

Roche’s Actemra/RoActemra (tocilizumab) is now approved in the EU for the treatment of adults with severe COVID-19 symptoms.

Longeveron’s Lomacel-B received an Orphan Drug Designation for the treatment of Hypoplastic Left Heart Syndrome.

President Joe Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.

Following mixed results from clinical trials, a panel of outside experts voted 13-10 to recommend Merck’s pill for Emergency Use Authorization.

Fully automated enzyme analysis can ease a persistent bottleneck in biocatalyst development for bio/pharmaceutical applications.

Subtitle FDA approved rituximab in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL.

High price tags threaten to block patient access to potentially life-saving cures and treatments.

EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.

Timing is everything, and it might be ideal for acceleration of real-time monitoring solutions.

Defining expectations, such as GMPs, is paramount for sourcing the right biopharmaceutical raw materials.

Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.

While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.

Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.

The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.

We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.

Biogen received MHRA marketing authorization for VUMERITY (diroximel fumarate) for treatment of relapsing-remitting multiple sclerosis (RRMS).

Scientific innovation and regulatory reformations are helping to drive the global biopharma market forward, but a balance between cost and value still needs to be accepted for widespread adoption.

FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.

Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

GSK has been granted approval by the EC for its monoclonal antibody therapy, Nucala (mepolizumab), as a treatment for three additional eosinophil-driven diseases.

EC has granted marketing authorization for Celltrion's Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19.

Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.

Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.