Drug Manufacturing

Takeda receives FDA approval for Vonvendi sBLA

Takeda Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) of an expanded indication for Vonvendi, for routine prophylaxis in adults with von Willebrand disease (VWD), including Types 1 and 2.

Polpharma Biologics signs biosimilars licensing deals with MS Pharma

Polpharma Biologics has entered into licensing agreements with MS Pharma to commercialise three proposed biosimilars in the Middle East and North Africa (MENA) region.

OMass signs deal with Genentech for IBD small molecules

OMass Therapeutics in the UK has signed an exclusive collaboration and licensing agreement with Roche Group member Genentech to develop and commercialise inflammatory bowel disease (IBD) therapies.

Piramal Pharma opens oral solid dosage suite in Pennsylvania, US

Piramal Pharma Solutions and NewAmsterdam Pharma have announced the inauguration of an oral solid dosage (OSD) suite at the former’s facility located in Sellersville, Pennsylvania, US.

Turbine and MSD aim to advance cancer treatment through AI simulations

Turbine, a Hungarian company specialising in AI cell simulations, is set to enter a research partnership with Merck & Co (MSD) to develop virtual models of cancer patient populations.

FDA grants orphan status for AlzeCure’s pain drug candidate

The US Food and Drug Administration (FDA) has granted orphan drug designation for AlzeCure Pharma’s pain drug candidate, ACD440.

Simtra BioPharma constructs production manufacturing building in Germany

Simtra BioPharma Solutions has constructed its new production manufacturing facility in Halle, Germany campus.

CHMP endorses ExCellThera’s stem cell transplantation product

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of conditional marketing authorisation for ExCellThera's cryopreserved haematopoietic stem cell transplantation product, Zemcelpro.

Johnson & Johnson submits sBLA to FDA to extend use of ustekinumab

Johnson & Johnson has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) to extend the use of the human interleukin (IL)-12 and IL-23 antagonist, Stelara (ustekinumab), for paediatric patients aged two and above with moderately to severely active Crohn's disease (CD).