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Pharmaceutical
US drug major Merck & Co, which operates in many countries as Merck Sharp & Dohme, says that the European Medicines Agency (EMEA) has accepted for review the company 27 August 2009
Pharmaceutical
US drug major Bristol-Myers Squibb says that its lead drug, Plavix (clopidogrel), the blood thinner co-marketed under an agreement with its originator, French giant Sanofi-Aventis, will be reviewed by the US Patent and Trademark Office (PTO). 20 August 2009
Pharmaceutical
California, USA-based Gilead Sciences has received a subpoena from the Office of the Inspector General of the Department of Health and Human Services requesting documents regarding the development, marketing and sales of Ranexa (ranolazine). 17 August 2009
Pharmaceutical
Switzerland-based Nycomed and US drugmaker Forest Laboratories have entered into an exclusive development, manufacturing and commercialisation agreement in the USA for Daxas (roflumilast), a once-daily oral treatment for patients suffering from symptomatic Chronic Obstructive Pulmonary Disease (COPD). Nycomed will retain marketing rights to the drug in Europe and the rest of the world. 11 August 2009
Biotechnology
Actelion, a major European biotechnology firm based in Switzerland, says that the US Food and Drug Administration has approved a new 20 microgram per milliliter (mcg/ml) formulation of Ventavis (iloprost) 10 August 2009
Biotechnology
Swiss biotechnology firm Actelion says that the US Food and Drug Administration has approved the company‘s supplemental New Drug Application for Tracleer (bosentan) to treat patients with mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH). The FDA has also approved Actelion‘s Risk Evaluation and Mitigation Strategy (REMS) for Tracleer. Jean-Paul Clozel, chief executive of Actelion commented: "Physicians in the United States of America who treat PAH patients now have access to Tracleer as an approved therapy for patients not only in advanced, but also in the early stages of this rapidly progressing and life-threatening disease. This label extension is based on EARLY, the only randomized, double blind, placebo controlled study in this mildly symptomatic patient population. The EARLY results demonstrate that Tracleer significantly reduces risk of clinical worsening in early-stage patients, thereby slowing down disease progression." Vallerie McLaughlin, associate professor of medicine and director of the Pulmonary Hypertension Program at the University of Michigan Health System, added: "PAH is a progressive and devastating disease, and patients are not always treated as early as they should be with therapies that can impact disease progression. The approval of Tracleer for the treatment of patients with early-stage disease, offers physicians a new, proven therapy that may result in beneficial clinical outcomes." 10 August 2009
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
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
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