Cardio-vascular
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Pharmaceutical
Xarelto (rivaroxaban) has been approved in the UK to treat venous thromboembolism (VTE) and to prevent VTE recurrence in children from birth to below 18 years after at least five days of initial parenteral anticoagulation treatment, including catheter related thrombosis, cerebral vein and sinus thrombosis. 1 February 2021
Pharmaceutical
Following the January meetings of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), 10 recommendations for novel drugs, as well as two biosimilars and one generic, were issued 30 January 2021
Pharmaceutical
Research results were a major feature in last week’s news, with yet another disappointment in the search for an Alzheimer’ disease therapy, as Biohaven Pharmaceuticals released Phase II/III trial results showing its candidate troriluzole missed its primary endpoint. Germany’s Merck KGaA and UK major GlaxoSmithKline last Wednesday revealed that the Independent Data Monitoring Committee has recommended discontinuation of the Phase III trial of bintrafusp alfa in cancer. On a more positive note, Eli Lilly presented new data showing that its biological drug bamlanivimab prevented people from contracting COVID-19. On the regulatory front, Germany’s Bayer and partner Merck & Co gained US Food and Drug Administration approval for their cardiovascular candidate Verquvo. 24 January 2021
Biotechnology
The Institute for Clinical and Economic Review (ICER) has published an evidence report on new therapies for treating high cholesterol. 22 January 2021
Pharmaceutical
A new product will enter the increasingly competitive cardiovascular space, with approval in the USA for Merck & Co and Bayer’s Verquvo (vericiguat). 21 January 2021
Pharmaceutical
German life sciences company Bayer has made clear its long-term ambitions to be an industry leader in the field of cell and gene therapy. 14 January 2021
Pharmaceutical
NewAmsterdam Pharma (NAP), a Dutch clinical-stage company focused on the research and development of transformative therapies for cardio-metabolic diseases, has completed an oversubscribed 160 million-euro ($196 million) Series A funding round. 14 January 2021
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) recommending Forxiga (dapagliflozin) for symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults, as an add-on to optimised standard care. 7 January 2021
Pharmaceutical
The US regulator has accepted the New Drug Application for Priority Review submitted for Farxiga (dapagliflozin), raising hopes the diabetes med could become the first SGLT2 inhibitor for people with chronic kidney disease (CKD), with and without type 2 diabetes. 6 January 2021
Biotechnology
German privately-held vascular integrity company Adrenomed today revealed that Wolfgang Baiker has been appointed as chief executive (CEO) effective January 1, 2021. 4 January 2021
Pharmaceutical
Takeda Pharmaceutical has signed an agreement to divest a portfolio of five select non-core prescription pharmaceutical products sold in China to Chinese firm Hasten Biopharmaceutic. 21 December 2020
Biotechnology
The US Food and Drug Administration on Friday issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. 21 December 2020
Pharmaceutical
The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 12 to 1 that the data presented support the use of Entresto (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF). 16 December 2020
Pharmaceutical
UK pharma major AstraZeneca has announced the launch of full-cycle production of Forxiga (dapagliflozin), its drug designed for the treatment of adult patients with type 2 diabetes mellitus and chronic heart failure, in Russia at the facilities of its local plant in the Kaluga region, according to recent statements, made by the company and the regional authorities, reports The Pharma Letter’s local correspondent 15 December 2020
Biotechnology
Rocket Pharmaceuticals, a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, closed 83% higher on Wednesday. 10 December 2020
Pharmaceutical
UK pharma major AstraZeneca has agreed to sell the rights to cholesterol-lowerer Crestor (rosuvastatin) and associated medicines in over 30 countries in Europe, except the UK and Spain, to family-owned German drugmaker Grünenthal. 1 December 2020
Biotechnology
Thousands of Australians with debilitating back and joint pain will have access to a life changing treatment option through the Pharmaceutical Benefits Scheme (PBS) which would otherwise cost tens of thousands of dollars. 30 November 2020
Pharmaceutical
British drugmaker AstraZeneca has picked up approval in Japan for Forxiga (dapagliflozin), as an option for people with chronic heart failure (HF). 30 November 2020
Biotechnology
Privately-held Chinese company Gmax Biopharm has announced that the first patient has received its humanized monoclonal antibody, GMA301, as part of investigations around the drug’s efficacy for the treatment of pulmonary arterial hypertension (PAH). 24 November 2020
Biotechnology
Swiss drug developer Idorsia has announced positive top-line results of the Japanese registration program investigating clazosentan in adult Japanese patients post-aneurysmal subarachnoid hemorrhage (aSAH). 24 November 2020
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Biotechnology
Anthos Therapeutics has presented data at the American Heart Association (AHA) Scientific Sessions from its landmark AZALEA-TIMI 71 study showing that abelacimab led to consistent and substantial reductions in bleeding for patients on or off antiplatelet (APT) therapy, compared to rivaroxaban. 18 November 2024
Pharmaceutical
Life science investors can be divided into two groups: those who bought Novo Nordisk stock before GLP-1s hit the big time, and those who wish they had. 10 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Biotechnology
Ascendis Pharma has granted fellow Denmark-based Novo Nordisk an exclusive worldwide license to the TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary products in metabolic diseases (including obesity and type 2 diabetes) and a product-by-product exclusive license in cardiovascular diseases. 4 November 2024
Pharmaceutical
Swiss pharma giant Novartis revealed rising sales and earnings in its third-quarter financial results on Tuesday. 29 October 2024
Pharmaceutical
Denmark-based Novo Nordisk’s oral semaglutide, marketed as Rybelsus for type 2 diabetes, has not gained much presence in the GLP-1 receptor agonists (GLP-1RAs) market despite its approval in 2019, as its injectable alternatives prove to have higher efficacy and results both in diabetes and obesity patients. 28 October 2024
Pharmaceutical
Germany’s Bayer has entered into an exclusive licensing agreement with privately-held Dewpoint Therapeutics for a heart disease program to treat dilated cardiomyopathy (DCM) patients, who are characterized through carrying specific mutations. 25 October 2024
Pharmaceutical
Philadelphia, USA-based SERB Pharmaceuticals has announced the acquisition of Aurlumyn (iloprost), the only FDA-approved treatment for severe frostbite in the USA. 22 October 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). 22 October 2024
Pharmaceutical
Novo Nordisk today announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomized trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). 21 October 2024
Generics
Lexicon Pharmaceuticals announced that Viatris has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the USA and Europe in all indications. 18 October 2024
Pharmaceutical
Johnson & Johnson has reported revenue of $22.5 billion for the third quarter of 2024, a 5.2% increase year-over-year. 15 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Pharmaceutical
Cardiopulmonary diseases specialist Liquidia Corporation closed Monday’s trading 11% higher following a favorable court ruling. 8 October 2024
Pharmaceutical
AstraZeneca has entered into an exclusive license agreement with China’s CSPC Pharmaceutical to advance the development of an early stage, novel small molecule lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidemia. 7 October 2024
Pharmaceutical
Privately-held metabolic health specialist Rivus Pharmaceuticals has announced new clinical data from the Phase IIa HuMAIN study of HU6 in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) 1 October 2024
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