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Biotechnology
Israeli biotech company Pluristem Therapeutics (TASE: PLTR), a developer of placenta-based cell therapies, has selected Cato Research as its contract research organization (CRO) for the German portion of the company's Phase II trial in intermittent claudication (IC), a subset of peripheral artery disease (PAD), under the auspices of the Paul-Ehrlich Institute (PEI). PAD is a condition that is currently mainly treated with Sanofi and Bristol-Myers Squibb's blockbuster blood thinner Plavix (clopidogrel), which is now facing generic competition. 14 August 2012
Pharmaceutical
The UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in draft guidance issued today (August 7), has recommended National Health Service use of independent French drugmaker Laboratoire Servier's Procoralan (ivabradine). 6 August 2012
Pharmaceutical
A rapid heart rate is a common condition among elderly individuals, and represents a potential goldmine for pharmaceutical companies who can improve on the current treatment offerings, states a new report by healthcare experts GlobalData, which shows that the supraventricular tachycardia (SVT) market contains several popular medications, but there is room to grow if superior efficacy and safety can be developed. 5 August 2012
Generics
The European Commission has informed French independent pharmaceutical company Servier and several of its generic competitors of its objections against practices potentially delaying the generic entry of perindopril, a cardiovascular drug. The move follows similar action last week relating to Danish firm Lundbeck's so-called pay-for-delay deals for citalopram (The Pharma Letter July 26). 31 July 2012
Biotechnology
The US Food and Drug Administration has approved biotech firm Amarin's (Nasdaq: AMRN) Vascepa (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG greater than or equal to 500mg/dL) hypertriglyceridemia (very high triglycerides). 30 July 2012
Pharmaceutical
Confirming its final draft guidance last month (The Pharma Letter June 1), in final guidance published today (July 25), the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has recommended German drug major Bayer's (BAYN: DE) oral anticoagulant Xarelto (rivaroxaban) as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism in adults diagnosed with acute deep vein thrombosis (DVT). 24 July 2012
Pharmaceutical
Ticagrelor, Anglo-Swedish drug major AstraZeneca's (LSE: AZN) blood-thinning drug Brilique/Brilinta which was approved by the Food and Drug Administration in 2011, should be considered along with older blood thinners clopidogrel and prasugrel for treating patients who are experiencing chest pain or some heart attacks, according to joint updated guidelines issued by the American Heart Association (AHA) Task Force on Practice Guidelines and the American College of Cardiology (ACCF) Foundation. 18 July 2012
Generics
Watson Pharmaceuticals (NYSE: WPI) says its subsidiary Watson Laboratories approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Next Choice ONE DOSE (levonorgestrel Tablet, 1.5 mg), the generic equivalent to Teva Women's Health's Plan B One-Step. Watson plans to launch the product immediately. 16 July 2012
Pharmaceutical
Privately-held Netherlands-based Nordic Group has reached an agreement with Germany's Bayer (BAYN: DE) to acquire worldwide rights excluding the USA for the surgical blood clotting agent Trasylol (aprotinin injection), marketing of which was suspended in 2008. 15 July 2012
Pharmaceutical
The US Food and Drug Administration has assigned a priority review designation to the supplemental New Drug Applications (sNDAs) filed on May 2 by Johnson & Johnson's (NYSE: JNJ) Janssen Research & Development subsidiary for (rivaroxaban), an oral anticoagulant for which the firms have US development and commercializing rights from Germany's Bayer (BAYN: DE), seeking new indications to treat patients with deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent recurrent DVT and PE. 10 July 2012
Pharmaceutical
The European Medicines Agency says it has been formally notified by French drug major Sanofi (Euronext: SAN) of its decision to withdraw its application for a centralized marketing authorization for its Mulsevo (semuloparin sodium), 20mg, solution for injection, which was intended to be used for the primary prophylaxis of venous thromboembolism (VTE) in cancer patients receiving chemotherapy for locally-advanced or metastatic solid tumors. 10 July 2012
Biotechnology
US biotech firm Chelsea Therapeutics International (Nasdaq: CHTP) shares tumbled in pre-market trading yesterday, after it received a written response from the Food and Drug Administration to the company's modified proposal for utilizing data from ongoing Study 306B to support its application for marketing approval of Northera (droxidopa) in the USA as a treatment for symptomatic orthostatic hypotension (SOH). The stock, already down significantly this year, fell a further 51% to $0.71. 4 July 2012
Pharmaceutical
AnGes MG (TYO: 4563) has concluded a basic agreement with fellow Japanese drugmaker Mitsubishi Tanabe Pharma (TYO: 4508) for the exclusive marketing rights of Collategene (DNA plasmid with HGF gene) as a treatment for peripheral arterial disease (PAD) in the USA. 4 July 2012
Pharmaceutical
US health care giant Johnson & Johnson's (NYSE: JNJ) European subsidiary Janssen-Cilag GmbH yesterday announced it has completed the acquisition of CorImmun GmbH, a privately held drug development company in Germany, for an undisclosed upfront payment and a contingent future clinical milestone payment. 29 June 2012
Pharmaceutical
A few days ahead of the expected decision date, the US Food and Drug Administration on Monday issued a complete response letter (CRL) regarding Bristol-Myers Squibb (NYSE: BMY) and Pfizer's (NYSE: PFE) New Drug Application for their anticoagulant Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The agency put Eliquis on "fast track" last year, indicating early approval. 26 June 2012
Pharmaceutical
The European Medicines Agency on Friday recommended restricting the use of trimetazidine-containing medicines in the treatment of patients with angina pectoris to second-line, add-on therapy. For all other indications the Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines were not sufficiently demonstrated and did not outweigh their risks. The CHMP therefore recommended their deletion from the marketing authorization. 24 June 2012
Pharmaceutical
Bayer HealthCare, a unit of Germany's Bayer (BAYN: DE) says that it has received a complete response letter from the US Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for the oral anticoagulant Xarelto (rivaroxaban) in combination with standard antiplatelet therapy for the reduction of secondary cardiovascular events (cardiovascular death, myocardial infarction or stroke) in patients with acute coronary syndrome (ACS). 22 June 2012
Pharmaceutical
Anglo-Swedish drug major AstraZeneca yesterday announced that full data results of the PLATO health economics sub-study, which have been published on-line in the European Heart Journal, demonstrate that even at a higher drug cost and incremental cost per acute coronary syndromes (ACS) patient, ticagrelor (known as Brilique in the European Union and Brilinta elsewhere) numerically lowered non-drug healthcare costs versus generic clopidogrel (Sanofi's now off-patent blockbuster blood thinner Plavix) and is cost-effective. 21 June 2012
Pharmaceutical
According to insights from US cardiologists and managed care organization (MCO) pharmacy directors surveyed by advisory firm Decision Resources, the reduced incidence of mortality is the greatest unmet need in post-myocardial infarction. Xarelto (rivaroxaban) has demonstrated potential to significantly fulfill this unmet need, it was revealed. 18 June 2012
Pharmaceutical
US drugmaker The Medicines Company (Nasdaq: MDCO) is expanding into Russia, through the start of sales of its drugs in the local market via the local Rayfarm consulting company. 14 June 2012
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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