Drug Manufacturing

FDA clears Auron’s AUTX-703 IND to treat haematological malignancies

The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application of Auron Therapeutics’ oral KAT2A/B degrader, AUTX-703, allowing it to progress through clinical development for haematological malignancies.

BioNTech concludes acquisition of biotechnology company Biotheus

BioNTech has completed the previously announced acquisition of biotechnology company Biotheus for $800m, a move that strengthens its oncology strategy.

EMA’s CHMP recommends approval of Bristol Myers Squibb’s HCC treatment combo

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC) in adults.

Rad AI raises $60m to accelerate generative AI technology development

Rad AI has raised an oversubscribed $60m in a Series C funding round to expedite the development and deployment of generative AI technology to healthcare providers and systems across the globe.

Scholar Rock submits application of SMA therapy to FDA

Scholar Rock has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for muscle-targeted therapy, apitegromab, aimed at enhancing motor function in individuals with spinal muscular atrophy (SMA) who are already on SMN-targeted therapies.

Atalanta Therapeutics secures $97m in Series B round to advance RNAi therapies

Atalanta Therapeutics has secured oversubscribed $97m in Series B financing to propel the Phase I trials of its RNA interference (RNAi) treatments targeting KCNT1-related epilepsy as well as Huntington’s disease.

Manas AI launches to focus on cancer medicine discovery

Manas AI has officially launched for transforming new cancer medicines discovery.

EMA validates X4’s mavorixafor application for WHIM syndrome treatment

The European Medicines Agency (EMA) has validated X4 Pharmaceuticals’ marketing authorisation application (MAA) submitted for mavorixafor, aimed at treating WHIM syndrome, a rare primary immunodeficiency.

FDA approves Amneal Pharmaceuticals’ Alzheimer’s and oncology treatments

The US Food and Drug Administration (FDA) has granted approval for Amneal Pharmaceuticals’ three medications, memantine/donepezil extended-release capsules and everolimus tablets for oral suspension, with tentative approval for rifaximin oral tablets.