In an agreement with MaaT Pharma, Skyepharma will build MaaT a dedicated 1500-m² microbiome ecosystem therapies manufacturing site.

Sartorius Stedim Biotech has completed the acquisition of the chromatography equipment division of Novasep.

The European Patent Office has granted another patent to Salipro Biotech, covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.

CGT Catapult has partnered with MICA Biosystems to advance MICA’s regenerative medicine technology to the UK’s MHRA.

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

MacroGenics will use Synaffix’s technology to investigate next-generation ADCs.

The acquisition will include Rewrite’s DNA writing platform, expanding Intellia’s genome editing tools.

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.

Bio-Rad’s four new antibodies will develop highly selective and sensitive assays for bioanalysis and drug monitoring of pertuzumab and its biosimilars.

A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.

Domainex is collaborating with Parkinson’s UK for the development of small-molecule therapies targeting the neuroinflammation that is associated with Parkinson’s disease.

ABPI has responded to the publication of a white paper on ‘Levelling Up’ by the government of the United Kingdom.

Zetta Genomics has raised £2.5 million ($3.4 million) in new seed funding.

Janssen has submitted a MAA to the EMA for teclistamab as a treatment of relapsed or refractory multiple myeloma (RRMM).

pharmasol has completed the strategic merger with PharmaLex.

Pharming Group has announced positive results from the Phase II/III study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).

The UK’s NICE issued a Final Appraisal Document recommending marketing authorization for AstraZeneca’s chronic kidney disease treatment, Forxiga (dapagliflozin).

Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants.

Eli Lilly and Company is investing $1 billion to establish a new manufacturing site in Concord, NC, to manufacture parenteral products and devices.

Eli Lilly and Company has entered into a research and collaboration agreement with Entos Pharmaceuticals to develop new therapeutics for treating neurologic disorders.

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.

As company revenues are gaining a boost from COVID-19, the issue of pricing is being debated once more.

The process of reshaping inevitably leads to fresh insights.

Busy is good for business.

Arranta Bio will use Cytiva’s FlexFactory single-use manufacturing platform to produce mRNA vaccines.

Recipharm will build up its biologics service offering with the acquisition of GenIbet.

Metagenomi has successfully raised $175 million for use toward its research pipeline.

Both Pfizer and Moderna have started clinical trials for their respective Omicron COVID-19 variant vaccine.