Drug Discovery

EMA CHMP recommends marketing authorisation for Novartis’ PNH treatment

Novartis has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorisation for Fabhalta (iptacopan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who suffer from haemolytic anaemia.

Evommune expands EVO756 collaboration with Maruho in Asia

Evommune has announced an expanded strategic partnership with Maruho for the development and commercialisation of EVO756 in Greater China and some Asian countries.

FDA committee recommends BMS-2seventy’s Abecma

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted in favour of Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel) for treating triple-class exposed relapsed or refractory multiple myeloma.

Tubulis secures $138.8m to develop ADCs for solid tumours

Tubulis has secured €128m ($138.8m) in a Series B2 financing round to expedite the clinical development of its antibody drug conjugates (ADCs) pipeline, focused on solid tumours.

FDA approves Novo Nordisk’s Wegovy for cardiovascular risk reduction

The US Food and Drug Administration (FDA) has granted approval for Novo Nordisk's Wegovy (semaglutide 2.4 mg) for lowering cardiovascular risks in adults with established cardiovascular disease (CVD) who are overweight or obese.

iOnctura receives orphan drug status for pancreatic cancer therapy

iOnctura has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its autotaxin inhibitor, cambritaxestat, for pancreatic cancer.

Sionna Therapeutics secures $182m for cystic fibrosis drug development

Sionna Therapeutics has announced the successful closure of a $182m Series C financing round for advancing the clinical development of small molecules aimed at treating cystic fibrosis (CF).

EMA validates Daiichi Sankyo-AstraZeneca’s cancer therapy applications

The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) for two types of cancer.

Kenai secures funds for neurological cell therapy development

Kenai Therapeutics has secured $82m in Series A financing round for the development of next-generation allogeneic cell therapies targeting neurological disorders.