SPX-001, a respiratory drug candidate, will be submitted through a combined Clinical Trial and Ethics Committee application for further advancement in the clinical stages.

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

Merck will purchase Imago BioSciences, a biotechnology company focused on bone marrow disorders, for approximately $1.35 billion.

The agreement aims to develop integrated technology for large-scale exosome production.

NMPA has approved Ferinject in China for the treatment of iron deficiency or iron deficiency anemia.

The complete online database of ACS Reagent Chemicals is now available.

The $286 million investment ability is designed to elevate MillioporeSigma’s ability to conduct biosafety testing and analytical development services.

The collaboration will see the companies develop investigational next-generation bispecific immunotherapies for cancer.

Rousselot Biomedical will supply Gelomics with its gelatin methacryloyl, a photo cross-linkable extracellular matrix, for use in Gelomics’ LunaGel 3D Tissue Culture System.

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.

Biotech startup, Cradle, has raised $5.4 million in seed funding with an AI-enabled design platform that allows for the synthetic building of cell factories to produce proteins.

Element has opened a new 7500-ft3 facility that will be used to evaluate aerosolized product efficacy for reducing airborne organisms and viral particles.

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

The deal will see Sanofi use Insilico’s AI drug discovery platform to advance up to six new drug development candidates.

Indivior’s acquisition of Opiant grants them access to the company’s portfolio of investigational opioid overdose reversal agent, OPNT003.

The new facility will allow ReiThera to consolidate its competitive position as a leading CDMO specialized in viral vector production.

Avantor is continuing its investment to support the biopharma market with the opening of its new distribution center in Dublin, Ireland.

Salipro Biotech has entered into a collaboration and license agreement with Sanofi to advance discovery programs.

The new Massachusetts facility will strengthen Cytiva’s cell culture services.

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

The latest guidance from FDA discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.

The collaboration will see Shimadzu and UMG develop new clinical laboratory methods using LC-MS for TDM analysis.

MGI and Imperial College will jointly operate a CEC designed to provide European customers with first-hand experience with various automation and sequencing instruments.

Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.

Industry and the government must work closely to ensure the UK remains a competitor in the clinical research field.

Gerresheimer and Nelson Labs will work together to conduct extractables and leachables testing on upcoming primary packaging solutions.