Cardiovascular

Bristol Myers Squibb secures expanded US approval for Camzyos

The US Food and Drug Administration (FDA) has expanded the approved indication for Bristol Myers Squibb’s (BMS) Camzyos (mavacamten) to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults and paediatric patients weighing at least 30kg (66lb).

EC approves Menarini and NewAmsterdam’s obicetrapib therapies

The European Commission (EC) has granted marketing authorisation to NewAmsterdam Pharma and Menarini Group for Ubeslo (obicetrapib 10mg monotherapy) and Evlarco (10mg obicetrapib plus 10mg ezetimibe fixed-dose combination).

Novartis India acquires Pfizer brands for $132m

Novartis India has agreed to pay Rs12.5bn ($132m) to acquire the Minipres and Minipress trademarks in India, along with certain associated intellectual property rights, from Pfizer and Pfizer Products.

Gossamer Bio announces $250m in funding to advance seralutinib

Gossamer Bio has announced a private placement agreement valued at up to $250m, including $150m of committed capital intended to support the development and potential US Food and Drug Administration (FDA) approval of seralutinib.

FDA grants fast track designation for HAYA Therapeutics’ HTX-001

HAYA Therapeutics has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational therapy, HTX-001, to treat symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

Evogene and ELEO to develop new oral PCSK9 inhibitors

Evogene and ELEO have entered a scientific collaboration aimed at discovering and developing new oral small-molecule inhibitors targeting the Proprotein convertase subtilisin/kexin type 9 (PCSK9) pathway for hyperlipidemia and cardiovascular diseases.

Affinia Therapeutics receives FDA orphan drug designation for AFTX-201

Affinia Therapeutics has received the US Food and Drug Administration (FDA) orphan drug designation for AFTX-201, a treatment in development for BAG3-associated dilated cardiomyopathy (DCM).

Viz.ai and Alnylam to advance earlier identification of cardiac amyloidosis

Viz.ai has entered a collaboration with Alnylam to advance earlier identification and streamline diagnosis for cardiac amyloidosis, an underdiagnosed cause of heart failure.

Cytokinetics receives FDA approval for MYQORZO tablets for oHCM

Cytokinetics has announced that the US Food and Drug Administration (FDA) has approved MYQORZO (aficamten) tablets in 5mg, 10mg, 15mg, and 20mg doses for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to enhance functional capacity and symptoms.