Drug Manufacturing

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).

Ferrer’s progressive supranuclear palsy therapy gains FDA fast track status

Ferrer's FNP-223 has secured fast-track designation from the US Food and Drug Administration (FDA), intended to slow down the development of progressive supranuclear palsy (PSP), a neurodegenerative disease.

FDA grants fast-track status to SolasCure’s gel for calciphylaxis ulcers

The US Food and Drug Administration (FDA) has granted fast track designation to SolasCure's investigational Aurase Wound Gel (AWG) for treating calciphylaxis ulcers.

MRI and Astellas to support Japanese drug-discovery startups

Japan’s Mitsubishi Research Institute (MRI) and Astellas Pharma have signed a memorandum of understanding (MoU) to support Japanese drug-discovery startups.