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Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical says it has received notice of sanctions imposed by the Japan Pharmaceutical Manufacturers Association for promotional activities regarding the Blopress (candesartan) antihypertensive survival evaluation in Japan CASE-J. 9 April 2014
Generics
Israel-based Teva Pharmaceutical Industries says it has received US Food and Drug Administration approval of the generic equivalent to Lovaza (omega-3-acid ethyl esters capsules, USP). 8 April 2014
Pharmaceutical
The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s Pradaxa (dabigatran etexilate mesylate) for additional indications, the firm’s US subsidiary announced today. 7 April 2014
Biotechnology
US biotech firm Amarin Corp and Kowa Pharmaceuticals America, owned by Japan’s Kowa, have reached an agreement to co-promote Amarin's flagship product, Vascepa (icosapent ethyl) capsules, in the USA. 1 April 2014
Pharmaceutical
German drug major Bayer presented new analyses from the pivotal ROCKET AF and EINSTEIN clinical trials at the American College of Cardiology’s 63rd Annual Scientific Session for its oral anticoagulant Xarelto (rivaroxaban). 1 April 2014
Pharmaceutical
Swiss drug major Novartis says that the Data Monitoring Committee (DMC) unanimously recommended early closure of the PARADIGM-HF study, based on the strength of interim results, with the news pushing the firm’s shares 3.7% higher to 75.15 Swiss francs by close of trading. 31 March 2014
Pharmaceutical
UK pharma major GlaxoSmithKline (LSE: GSK) presented disappointing data from its pivotal Phase III STABILITY study of heart disease drug darapladib at the American College of Cardiology 63rd Annual Scientific Session in Washington DC, yesterday (March 30). 31 March 2014
Biotechnology
USA-based Amgen announced data at the American College of Cardiology 63rd Annual Scientific Session this weekend from three Phase III studies that showed its novel investigational cholesterol-lowering medication evolocumab (AMG 145) resulted in a statistically significant reduction of 55%-66% in low-density lipoprotein cholesterol (LDL-C) compared to placebo in patients with high cholesterol. 31 March 2014
Pharmaceutical
The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted unanimously (11-0) against approval for Swiss pharma major Novartis’ RLX030 (serelaxin) for the treatment of acute heart failure (AHF). 28 March 2014
Generics
Indian drugmaker Lupin says that its US subsidiary has launched its niacin extended-release tablets USP, 500mg, 750mg, 1,000mg strengths having received final approval from the US Food and Drug Administration. 24 March 2014
Pharmaceutical
New US guidelines regarding those patients who are prescribed statins to prevent cardiovascular disease would see the number of people taking the drugs rise by 12.8 million, according to a report in the New England Journal of Medicine. 20 March 2014
Biotechnology
Leading independent biotech firm Amgen has released more positive clinical trial data with its cholesterol lowering drug candidate evolocumab, news which pushed its share price 2.1% higher to $125.13 in early trading. 17 March 2014
Pharmaceutical
The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New Drug Application for blood thinner Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. 16 March 2014
Pharmaceutical
India’s largest drugmaker Ranbaxy Laboratories (BSE: 500359) has recalled more than 64,000 bottles of the generic version of Pfizer’s cholesterol drug Lipitor (atorvastatin) in the USA. 10 March 2014
Pharmaceutical
French drug major Sanofi has revealed in a regulatory filing that the US Food and Drug Administration has directed the company, and US partner Regeneron, to determine whether any neurocognitive adverse events occurred in any trials of the global development program for their experimental PCSK9 inhibitor alirocumab, particularly in longer-term studies. 10 March 2014
Pharmaceutical
Takeda Pharmaceutical, Japan’s largest drugmaker, has submitted a New Drug Application to the Japanese Ministry of Health, Labor and Welfare for trelagliptin succinate (SYR-472), a once weekly dosage treatment for type 2 diabetes. 9 March 2014
Biotechnology
US biotech firm Amarin revealed in a Stock Exchange Commission submission that it has filed a complaint in the US District Court for the District of Delaware against Omthera Pharmaceuticals and its parent company, Anglo-Swedish drug major AstraZeneca. 5 March 2014
Generics
Ireland-headquartered generic drugmaker Actavis revealed on Friday (February 28) that French pharma giant Sanofi had filed suit on February 26, in the US District Court for the District of Delaware, seeking to prevent Actavis from commercializing its Abbreviated New Drug Application for a generic version of Multaq (dronedarone) prior to the expiry of certain US patents. 2 March 2014
Biotechnology
US biotech firm Amarin has filed with a federal court requesting it to order the US Food and Drug Administration to extend its marketing exclusivity for Vascepa (icosapent ethyl), an adjunct to diet to reduce triglyceride, for five years, according to a report from Bloomberg. 28 February 2014
Pharmaceutical
A study looking at the data of thousands of patients who suffered heart attacks has suggested treatment with high-potency statins offers a significantly improved chance of survival compared to those taking normal statins. 21 February 2014
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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