Drug Manufacturing

NICE recommends Cara’s Kapruvia to treat CKD-associated pruritus

Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) have announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended Kapruvia (difelikefalin) to treat chronic kidney disease (CKD)-associated pruritus.

Melinta, Xediton partner to commercialise anti-infective products in Canada

Melinta Therapeutics and Xediton Pharmaceuticals have entered an exclusive commercialisation and licensing agreement for four novel anti-infective products.

FDA completes inspection of Nexus’ manufacturing facility in US

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US.

US FDA approves Ajinomoto Bio-Pharma’s new fill line

The US Food and Drug Administration (FDA) has granted approval for Ajinomoto Bio-Pharma Services’ high potency vial line to manufacture a commercial product.

Chiesi Farmaceutici acquires biopharmaceutical firm Amryt Pharma

Chiesi Farmaceutici has completed the previously announced acquisition of global, commercial-stage biopharmaceutical company Amryt Pharma.

ImmuneBridge raises funds to advance new cell-based immunotherapies

Biotechnology company ImmuneBridge has raised $12m seed financing to advance new natural killer (NK) cell-based immunotherapies.

OncoVent signs agreement with Orient EuroPharma for oregovomab

Shenzhen Hepalink Pharmaceutical Group’s subsidiary OncoVent has entered into a licence and distribution agreement with Orient EuroPharma (OEP) for the immunotherapeutic drug candidate, oregovomab.

Timber’s TMB-001 receives orphan drug designation from EC to treat XLRI

Timber Pharmaceuticals has received orphan drug designation from the European Commission (EC) for TMB-001 to treat X-linked recessive ichthyosis (XLRI).

Icosavax receives fast track designation for IVX-A12 vaccine candidate

Icosavax has received fast track designation from the US Food and Drug Administration (FDA) for its bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) VLP vaccine candidate, IVX-A12, in older adults aged 60 years and above.