The latest episode of the DDW Highlights Podcast is now available to listen to below. DDW’s Bruno Quinney narrates five key stories of the previous week to keep DDW subscribers up-to-date on the latest industry news. Last week, a report showed patients in Europe face barriers to medicine access. Elsewhere,… Read More
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Baxfendy (baxdrostat) in the US for the treatment of hypertension. Baxfendy has been approved as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not… Read More
The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for hypertension drug lorundrostat. Biopharmaceutical company Mineralys Therapeutics announced the NDA for lorundrostat was accepted for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. The FDA has assigned a Prescription Drug User Fee Act… Read More
GSK will pay $950 million for Canadian biopharmaceutical company 35Pharma, specialised in the development of novel protein-based therapeutics. The acquisition includes HS235, a potential best-in-class investigational medicine that has completed Phase I healthy volunteer clinical trials, with studies to start imminently in pulmonary arterial hypertension (PAH) and… Read More
An innovative drug developed to treat idiopathic pulmonary fibrosis (IPF) will now be evaluated as a treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD). CS014, a HDAC inhibitor developed by biotech company Cereno Scientific, will be studied as a treatment for PH-ILD to address a… Read More
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Corcept Therapeutics regarding the New Drug Application (NDA) for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism. While the FDA acknowledged that Corcept’s pivotal GRACE trial met its primary… Read More
Halo Biosciences has announced publication of results in Thorax from the Phase IIa SATURN study for patients with pulmonary hypertension and interstitial lung disease (PH-ILD). The study, conducted at Stanford University, evaluated 4-methylumbelliferone (4-MU) in patients with pulmonary hypertension, a highly progressive disease with significant unmet needs. The Phase IIa… Read More
The European Commission has granted orphan medicinal product designation (OMPD) to Cereno Scientific’s lead drug candidate CS1 for pulmonary arterial hypertension (PAH). CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed to offer improved quality of life and prolonged life for patients with… Read More
The US Food and Drug Administration (FDA) has approved Tryvio (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Tryvio (aprocitentan) is an endothelin receptor antagonist that inhibits… Read More
Alnylam Pharmaceuticals has revealed results from its Phase I study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension. The results are published in the New England Journal of Medicine (NEJM). The key data showed that… Read More
Janssen has submitted a marketing authorisation application to the European Medicines Agency (EMA) seeking approval of single tablet combination therapy (STCT) of macitentan and tadalafil for pulmonary arterial hypertension (PAH). The single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) is intended for… Read More
AstraZeneca has entered into an agreement to acquire CinCor Pharma, a clinical-stage biopharmaceutical company, focused on developing treatments for resistant and uncontrolled hypertension as well as chronic kidney disease. As part of the deal, the company will acquire CinCor’s candidate drug, baxdrostat (CIN-107), an aldosterone synthase inhibitor… Read More
The last patient has completed a clinical trial investigating the use of a digital platform to help patients with hypertension personalise and optimise their therapy regime. The PERSONAL COVID BP clinical trial was organised by therapeutics company Closed Loop Medicine to assess the use of its smartphone app to monitor… Read More
