The new General Chapter <1469> “Nitrosamines Impurities” by USP became official on Dec. 2, 2021, in the United States Pharmacopeia—National Formulary.

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.

Lean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.

Chinook Therapeutics has formed a 50/50 joint venture with investors to develop kidney disease therapies in China.

Sartorius is investing €100 million (US$113 million) between 2021 and 2025 to expand capacities for production, innovation, and storage at its French facilities in Aubagne, Cergy, and Lourdes.

Sartorius will invest approximately €270 million (US$305 million) to expand its biopharmaceutical manufacturing activities in South Korea’s biopharm hub.

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.

Pharma and biotech are ruling the roost in terms of university innovation, but European spinouts are still experiencing barriers to long-term success.

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

CordenPharma will build a clinical trial development facility for manufacture of oral solid dosage drug products at its Plankstadt facility near Heidelberg, Germany.

Researchers from MIT have developed novel nanosensors for the detection of the nucleocapsid and spike protein of the SARS-CoV-2 virus.

Novozymes and Novo Nordisk Pharmatech are teaming up to develop best-in-class technical enzymes to support biopharmaceutical production processes.

BeiGene has acquired property in Hopewell, NJ to build a new manufacturing site and clinical R&D center for advanced new medicines.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

The companies are testing their existing vaccines against the new variant of concern and are pursuing variant-specific versions.

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

Samsung Biologics will manufacture GreenLight BioSciences' COVID-19 vaccine candidate for clinical trials and commercial sales.

PathoQuest is the first French contract research organization (CRO) capable of offering GMP grade NGS-based testing services for quality control of biological drugs.

Donaldson Company's acquisition of Solaris Biotechnology is intended to expand their footprint in the life sciences market.

Flywheel's platform will aid Roche and Genentech in the aggregation and management of medical imaging data.

ACG plans to open a capsule manufacturing plant and R&D center in Aurangabad, India.

The study found that patients treated with BIMZELX (bimekizumab) achieved 50% or greater improvement in arthritis signs and symptoms relative to those treated with placebo.

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

Benchling raised $100 million to expand in Europe and further develop it's cloud-based R&D platform.

AstraZeneca has unveiled its new facility, The Discovery Centre, which will be used to support the company's focus on precision and specialized medicines, and to foster industry collaboration.

Eppendorf has donated €20,000 (US$22,400) to the European Molecular Biology Laboratory (EMBL) in support of the “Advancement of Women in Science” project.

The EC has granted marketing authorization for Gilead’s Trodelvy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer.

MilliporeSigma’s new ColorWheel flow cytometry portfolio is designed to create antibodies and dyes analogous to a primary conjugated antibody.