Drug Manufacturing

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).

US FDA clears Calidi’s CLD-201 for clinical development in solid tumours

The US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for CLD-201, an allogeneic stem cell-based immunotherapy developed by Calidi Biotherapeutics, set to advance into clinical development for solid tumours.

Glycomine secures $115m funding for Phase IIb trial of rare disease drug

US-based biotechnology company Glycomine has secured $115m in Series C funding to progress the mannose-1-phosphate replacement therapy GLM101 into a randomised Phase IIb trial.

Norgine agrees to acquire Theravia

Norgine has entered into a definitive agreement to acquire Theravia, a pharma laboratory that specialises in rare and debilitating condition treatments.

INmune Bio, CGT Catapult to set up manufacturing for cell therapy platforms

INmune Bio has collaborated with the Cell and Gene Therapy Catapult (CGT Catapult) to set up large-scale manufacturing for its cell therapy platforms.

Nona Biosciences and Atossa team up to discover breast cancer therapies

Nona Biosciences has entered into a research collaboration with Atossa Therapeutics for the discovery of next-generation antibody therapies for treating breast cancer.

Imbria secures $57.5m to advance ninerafaxstat through Phase IIb nHCM trial

Imbria Pharmaceuticals has secured $57.5m in a Series B funding round to support the progression of ninerafaxstat through a double-blind Phase IIb FORTITUDE-HCM trial in non-obstructive hypertrophic cardiomyopathy (nHCM).