BioPharm International Editors

The guidance aids in the development, validation, and use of near infrared-based analytical procedures.

Novavax and European Commission have finalized an agreement to purchase up to 200 million doses of a COVID-19 vaccine.

BeiGene plans to build a new campus for R&D and commercial-scale biopharmaceutical manufacturing in Hopewell, NJ.

Catalent finalizes their acquisition of iPSC developer and manufacturer RheinCell Therapeutics.

Syngene International appoints two US-based executives to senior level positions.

A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.

Nanoform and Boehringer Ingelheim have executed a master services agreement in relation to pre-clinical development projects.

EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.

The University of Sheffield has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

A research collaboration will combine Imugene’s oncolytic virus technology with Celularity’s allogeneic CAR T-cell therapy.

FDA approved an expanded Botox label, which now includes eight new muscles to treat adults with upper limb spasticity.

Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.

FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.

The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.

FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.

FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.

GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.

Syntegon's Syringe Inspection Line utilizes an AI vision system for the inspection of syringe flanges, stoppers, and cylinders.

The Cytomat 24 automated incubator system is designed for large-capacity microplate processing.

SP Scientific's SALS30 and RxR-36 are designed for fill/finish processing applications like freeze dryers.

Eppendorf's CryoCubeF440 freezer has been redesigned to promote sustainability through various green features.

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

Entries are now open for the 18th Annual CPhI Pharma Awards in Milan.

VICO Therapeutics’ drug candidate, VO659, for treating Huntington’s Disease was granted orphan drug designation by FDA.

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

ERS Genomics and Japan SLC have signed a non-exclusive license agreement, allowing Japan SLC access to ERS Genomics’ CRISPR/Cas9 patent portfolio.