News

The new partnership between Sandoz, a Novartis division, and Just – Evotec Biologics will aim to develop and manufacture multiple biosimilars.

The objective of the partnership is to automate portions of ScaleReady’s CGT manufacturing workflow by using Cellular Origin’s robotic system for sterile liquid transfer.

EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).

Critical raw materials supplier, Biosynth, has acquired UK-based Cambridge Research Biochemicals (CRB).

Vetter is further expanding its production capacity and services at its Rankweil, Austria site.

The guidance is to provide information on compliance with applicable regulatory requirements and recommendations.

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

GSK’s Alexvy vaccine is the first to receive FDA approval for respiratory syncytial virus.

Private investors from Advent International and Warburg Pincus will operate the assets as an independent CDMO.

Boehringer Ingelheim will use Ginkgo’s metagenomic sequence database to identify potential lead molecules for diseases with high unmet patient needs.

According to a press release, SGS has doubled its capacity for nitrosamine testing for North American customers.

The new portfolio from the acquisition will include contract research organization solutions, contract development and manufacturing organization solutions, and KSM/API solutions.

The new agreement is based off the Master Services Agreement that both companies entered in 2021 for the development, manufacture, and supply of rhenium (186Re) obisbemeda, according to a press release.

These models are useful in predicting whether an unknown substance of abuse can permeate the BBB to produce effects predicted by the Public Health Assessment via Structural Evaluation (PHASE) approach.

The recent revision is intended to provide guidance on QRM principles and tools that can be used for different aspects of pharmaceutical quality.

Presspart will still be responsible for the manufacturing of the Sunriser device.

mRNA therapeutics are being researched to support the fight against rare diseases, infectious viruses, and cancers.

Competition in the organ-on-a-chip market increases as NETRI enters the arena.

This specific guidance refers to a DCT as a clinical trial where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

The new research and development capacities set the stage for completion of product development for LEON’s manufacturing devices and will be used to showcase the devices and provide process development services to clients using LEON’s equipment.

The acquisition was completed through the merger of a wholly owned subsidiary of Sanofi with and into Provention Bio.

Strike action is impacting numerous sectors across Europe, including the bio/pharma industry.

The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.

clonoSEQ Assay is authorized by FDA for MRD assessment in lymphoid malignancies and is highly accurate, sensitive, and standardized compared to other technologies used for disease burden assessment.

The results found that repeatability testing found all 15 processes to be with in specification for target final concentration.

Aspect Biosystems and Novo Nordisk A/S have announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics.

The leaked study summary found that Carvykti (ciltacabtagene autoleucel) reduced disease progression by 74%.

The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.

BioChain has reached partnerships with NanoString and 10x Genomics to extend its spatial multiomics services.

JMI Laboratories and bioMérieux will work to improve microbiology diagnostics tools.