Drug Manufacturing

PCI completes acquisition of sterile fill-finish CDMO Ajinomoto Althea

PCI Pharma Services (PCI) has concluded the acquisition of Ajinomoto Althea, a sterile fill-finish contract development and manufacturing organisation (CDMO) based in the US.

Er-Kim to distribute Puma’s Nerlynx in Central Asian, Eastern European countries

Pharmaceutical company Er-Kim has entered into an agreement with Puma Biotechnology for the distribution of the latter’s Nerlynx (neratinib), aimed at treating breast cancer, in certain Central Asian and Eastern European countries.

Abeona announces FDA approval for cell-based gene therapy for RDEB patients

Abeona Therapeutics has announced receipt of the US Food and Drug Administration (FDA) approval for gene-modified cellular sheet therapy Zevaskyn for the wound treatment in both adult and paediatric patients suffering from recessive dystrophic epidermolysis bullosa (RDEB), a serious genetic skin condition.

EMA grants orphan drug status to Purespring’s IgA nephropathy treatment

The European Medicines Agency (EMA) has granted orphan drug designation to UK-based Purespring Therapeutics’ lead candidate, PS-002, aimed at treating IgA nephropathy (IgAN).

Apnimed acquires rights to sleep apnoea treatment from Desitin Arzneimittel

Apnimed has acquired the intellectual property and exclusive worldwide rights from European pharma company Desitin Arzneimittel for developing and commercialising a differentiated carbonic anhydrase inhibitor, sulthiame, targeting sleep apnoea and sleep-related breathing conditions.

Tempus AI, AstraZeneca, and Pathos AI join forces on cancer care

Tempus AI has entered into strategic partnerships with AstraZeneca and Pathos AI to develop a multimodal foundation model in oncology.

NICE issues final guidance endorsing Pharming’s APDS therapy

The National Institute for Health and Care Excellence (NICE) has issued final guidance endorsing Pharming Group’s Joenja (leniolisib) for use and reimbursement in the National Health Service (NHS) in England and Wales.

Ensem Therapeutics’ application for ETX-636 secures FDA clearance

Ensem Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for ETX-636.

Viatris files applications in Japan for approval of Effexor to treat GAD

Viatris has submitted applications to Japan's Ministry of Health, Labor and Welfare (MHLW) for the approval of Effexor SR Capsules (venlafaxine hydrochloride) to treat adults with generalised anxiety disorder (GAD).