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Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) is asking independent German drug major Boehringer Ingelheim for more information on its product dabigatran Pradaxa) (dabigatran), its new drug for the prevention of stroke and systemic embolism in people with atrial fibrillation. 18 August 2011
Pharmaceutical
Data newly-published in the New England Journal of Medicine (NEJM) demonstrate that German drug major Bayer (BAY: DE) and the USA's Johnson & Johnson's (NYSE: JNJ) one tablet once-daily, oral, direct Factor Xa inhibitor Xarelto (rivaroxaban) successfully met its primary efficacy endpoint versus dose-adjusted warfarin in the double blind, double dummy ROCKET AF Phase III clinical study. The principal safety outcome - the composite of major and non-major clinically relevant bleeding events - was similar in both treatment arms. 12 August 2011
Pharmaceutical
Type 2 diabetes patients, who face higher risk of cardiovascular disease, often take a combination of medications designed to lower their low-density lipoprotein (LDL) or "bad" cholesterol and triglyceride levels while raising their high-density lipoprotein (HDL) or "good" cholesterol because doctors long have thought that taken together, the drugs offer protection from heart attacks and improve survival. 11 August 2011
Generics
US drugmaker Watson Pharmaceuticals (NYSE: WPI) says that its subsidiary, Watson Laboratories, has received tentative approval from the US Food and Drug Administration for its rosuvastatin zinc 5, 10, 20 and 40mg tablets. 10 August 2011
Pharmaceutical
There was good news for independent German drug major Boehringer Ingelheim yesterday, when the company gained European Union approval for its breakthrough oral anticoagulant, Pradaxa (dabigatran etexilate) for the prevention of stroke in patients with atrial fibrillation (AF) at risk of stroke. This adds to the drug's clearance last year in this indication in the all important US market (The Pharma Letter October 20, 2010), as well as in Canada, Japan, Australia and several other countries across four continents, the company noted. 5 August 2011
Generics
Japanese drug major Daiichi Sankyo (TYO: 4568) and its 64% owned Indian affiliate Ranbaxy Laboratories RANB: BO) plan to expand their business in Mexico to maximize their Hybrid Business Model, encompassing both innovative and affordable, high quality, generic medicines. Mexico is the second largest pharma market in Latin America, with drug sales last year estimated at $11.4 billion. 2 August 2011
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) revealed this morning that it has received approval in 23 European Union member states and Norway for Axanum, a fixed dose combination of 81mg low-dose ASA (acetylsalicylic acid; aspirin) and 20mg esomeprazole. 2 August 2011
Pharmaceutical
The value of the global hypercholesterolemia therapeutics - cholesterol lowerers - market was put at $29.4 billion in 2010 and is forecast to expand at a compound annual growth rate (CAGR) of 3.9% for the next seven years to reach $38.5 billion by 2017, according to a new report from industry analysts GlobalData. 28 July 2011
Pharmaceutical
Following a previous positive draft guidance, the UK drugs watch dog the National Institute for Health and Clinical Excellence today has now recommended National Health Service use of USA-based The Medicines Company's (Nasdaq: MDCO) Angiox (bivalirudin), in combination with aspirin and clopidogrel for the treatment of adults with ST-segment-elevation myocardial infarction (STEMI or heart attack) undergoing emergency lifesaving procedures to unblock their coronary arteries (primary Percutaneous Coronary Intervention or PCI; The Pharma Letter June 20). 27 July 2011
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) has entered into an agreement with Japan's Astellas Pharma (TOY: 4503) to acquire the exclusive rights to develop and commercialize the investigational intravenous formulation of vernakalant in Canada, Mexico and the USA from Astellas. 26 July 2011
Pharmaceutical
The US Food and Drug Administration says it is reviewing data from a clinical trial that was evaluating the effects of French drug major Sanofi's (Euronext: SAN) antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation. 25 July 2011
Generics
US pharma giant Merck & Co (NYSE: MRK) has signed a framework agreement with leading Chinese drugmaker Simcere Pharmaceuticals (NYSE: SCR) to establish a joint venture focused on serving China's rapidly expanding health care needs by providing significantly improved access to quality medicines in major therapeutic areas. Setting up of the JV is subject to satisfying certain agreed to closing conditions. 22 July 2011
Pharmaceutical
There was much awaited good news for Anglo-Swedish drug major AstraZeneca (LSE: AZN) last night, when the US Food and Drug Administration approved the company's blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). 21 July 2011
Pharmaceutical
Building on its cardiovascular portfolio, Japanese drug major Daiichi Sankyo (TYO: 4568) has launched its anti-blood clotting drug Lixiana (edoxaban) in Japan. The drug was recently approved by the Japanese Ministry of Health, Labor and Welfare (The Pharma Letter April 26) and marks the first time edoxaban is commercially available to patients in any global market, the company noted. 20 July 2011
Pharmaceutical
Ahead of an advisory panel meeting scheduled for tomorrow (July 19) to discuss US drug major Bristol-Myers Squibb (NYSE; BMY) and Anglo-Swedish AstraZeneca's (LSE: AZN) New Drug Application for their diabetes drug candidate dapagliflozin, the US Food and Drug Administration issued briefing papers suggesting that, while it is seen to be effective, the drug may increase the risk of bladder and breast cancer. 18 July 2011
Biotechnology
French drug major Sanofi (Euronext: SAN) and its US biotech subsidiary Genzyme have announced mixed top-line results from CARE-MS I, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab (to use the trade name Lemtrada if approved for multiple sclerosis) to the approved MS therapy, Merck KGaA's Rebif (high dose subcutaneous interferon beta-1a), in patients with relapsing-remitting multiple sclerosis (RRMS). Genzyme is developing alemtuzumab in MS in collaboration with Germany's Bayer HealthCare. 12 July 2011
Generics
US drugs behemoth Pfizer (NYSE: PFE) could extend the European patent term for its al-time blockbuster cholesterol lowerer Lipitor (atorvastatin) as a result of pediatric studies, which could mean an additional $800 million in sales for the drugmaker, reports the UK's Financial Times. 11 July 2011
Pharmaceutical
In two clinical disappointments announced yesterday, French drug major Sanofi (Euronext: SAN) and Germany's Merck KGaA (MRK: DE) each pulled the plug on studies due to safety concerns. Sanofi saw its shares dip 1.1% to 55.30 euros. 8 July 2011
Pharmaceutical
German drug major Bayer (BAY: DE) and US marketing partner Janssen Pharmaceuticals, a unit of Johnson & Johnson (NYSE: JNJ) says that the US Food and Drug Administration has approved their Xarelto (rivaroxaban), a novel, once-daily, oral anticoagulant for the prevention of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery, an indication it already has in Europe. 4 July 2011
Generics
Despite the fact that US drugs behemoth Pfizer (NYSE: PFE) has patent protection for its blockbuster cholesterol lowerer Lipitor (atorvastatin) well into next year, Israel-headquartered Teva Pharmaceutical Industries (Nasdaq: TEVA) last month started selling a generic version Lipitor in the UK, reports the Financial Times. 4 July 2011
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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