Welcome to
Endpoints News
’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more.
The FDA has
accepted
Satsuma Pharmaceuticals’ NDA resubmission
for its nasal migraine drug, dubbed STS101, with a PDUFA date of April 30, according to a Tuesday release. The agency previously
rejected
the drug in January over CMC issues.
Hovione is
expanding
its manufacturing facility in Cork, Ireland and East Windsor, NJ, the company said Tuesday. The expansion will add 40 new jobs across both locations and will boost its spray drying services for oral and inhaled drugs. Liquids are fed into hot nitrogen gas and then rapidly dried to become a solid product. No financial details were disclosed.
German CDMO Adragos Pharma
is acquiring
aseptic fill-finish manufacturer Baccinex, the company
said
Monday. Adragos will gain Baccinex’s factory in Jura, Switzerland. No financial or timeline details were given.
Gelteq
said
Tuesday
it will start making
400,000 units of its gel solution, which is used for drug delivery, for clients in the US and Australia.
A new draft of US legislation was
introduced
on Thursday, which has called for more information to be added to the Federal Food, Drug and Cosmetic Act. The bill seeks to increase the monitoring of drugs to prevent shortages.
Reagent supplier Gemini Bioproducts
has
acquired
Bio-Techne’s fetal bovine serum portfolio, the company said Monday. Gemini will thus handle the manufacturing and global sales for three fetal bovine serum brands.
