Cardio-vascular
Refine Search
Generics
Ohm Laboratories, a wholly owned subsidiary of India’s largest drugmaker Ranbaxy Laboratories, has received approval from the US Food and Drug Administration to manufacture and market valsartan, a generic of Swiss drug major Novartis’ Diovan, for the treatment of high blood pressure and heart failure. 27 June 2014
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy designation to idarucizumab, an investigational fully-humanized antibody fragment, or Fab, being studied as a specific antidote to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate), by German family-owned drug major Boehringer Ingelheim. 26 June 2014
Pharmaceutical
The US Food and Drug Administration has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure drug olmesartan in diabetic patients. 25 June 2014
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceuticals has updated on the third-party surrounding the results of the CASE-J study, a clinical study related to the hypertension drug Blopress (candesartan cilexetil), namely “potential involvement in data analysis and data falsification,” “potential conflicts of interest,” and “inappropriate promotional activities.” 23 June 2014
Pharmaceutical
Australian pharma regulator the Therapeutic Goods Administration (TGA) is reviewing new information regarding ivabradine (Coralan), French independent drugmaker Servier’s cardiovascular drug approved in the European Union as Procoralan, identified in the preliminary results of a study into the medicine. 23 June 2014
Pharmaceutical
UK health care watchdog the National Institute for Health and Care Excellence (NICE) has today published updated draft guidance recommending National Health Service use of US pharma major Eli Lilly’s Efient (prasugrel) in combination with aspirin for preventing blood clots in people who have had a heart attack or who have unstable angina and who are also having a procedure to widen narrowed arteries in the heart (percutaneous coronary intervention). 20 June 2014
Pharmaceutical
US health care giant Johnson & Johnson, through its J&J Innovation unit, today announced 12 new alliances with life science companies and research institutions around the globe to explore early-stage innovation in a broad range of therapeutic areas and across pharmaceuticals, medical device and diagnostics and consumer health care. 19 June 2014
Pharmaceutical
Thousands of people with atrial fibrillation could be saved from strokes, disability or death because of new guidance from the UK’s National Institute for Health and Care Excellence (NICE). 18 June 2014
Pharmaceutical
A new report titled Research on China Cardiovascular Drugs Industry 2014-2018, says that, in the next 10 years, there is a potential for the growth in cardiovascular diseases treatment field. 13 June 2014
Pharmaceutical
Statins, already the most prescribed drugs in history, are being recommended for more and more patients as "primary prevention" for cardiovascular disease. Nearly 900 studies have been published on the adverse effects of these medications, and a look at their mechanism of action suggests ample reason for caution. Neurospecialist and pharmacologist Timothy Marshall, discusses the controversy in the summer issue of the Journal of American Physicians and Surgeons. 13 June 2014
Pharmaceutical
Obesity-focused US biopharmaceutical company Orexigen Therapeutics says that the US Food and Drug Administration has extended its review of the resubmitted New Drug Application for its investigational medication Contrave (naltrexone SR and bupropion SR; NB32), being evaluated for weight loss. The company’s shares dropped 15% to $5.80 in premarket trading today. 11 June 2014
Pharmaceutical
The high cost of therapy remains a significant barrier for uptake of novel oral anticoagulants (NOACs) in the Chinese market. Warfarin, the mainstay of anticoagulation treatment, is listed in the national essential drugs list and is therefore fully reimbursed by the public health insurance schemes. 10 June 2014
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim said today that its blood thinner Pradaxa (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis and pulmonary embolism. 6 June 2014
Pharmaceutical
UK pharma major GlaxoSmithKline has announced the start of a pivotal Phase III study, LATITUDE-TIMI 60, to evaluate the effects of losmapimod in patients presenting with acute coronary syndrome. 6 June 2014
Pharmaceutical
Multiple major drug patent expiries will cause the global anti-hypertensive drug market value to decline from $40 billion in 2013 to $37.6 billion by 2020, at a negative compound annual growth rate (CAGR) of 0.9%. 4 June 2014
Pharmaceutical
After facing more than 2,000 law suits in the USA, claiming Pradaxa (dabigatran) caused severe or fatal bleeding, German family-owned pharma major Boehringer Ingelheim has reached a $650 million settlement of all state and federal cases in the US litigation regarding Pradaxa (The Pharma Letter May 28). 2 June 2014
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim says it has reached a comprehensive settlement of US state and federal cases in the litigation regarding severe and fatal bleeding in patients said to have been caused its blockbuster blood thinner Pradaxa (dabigatran etexilate mesylate), in the amount of $650 million. 28 May 2014
Pharmaceutical
Daiichi Sankyo said this morning that it has launched its anti-blood clotting drug Efient (prasugrel HCl) 3.75mg/5mg tablets in Japan. This follows the approval of the drug on May 24 and National Health Insurance (NHI) listing of May 23, the company noted. 27 May 2014
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has for a second time adopted a negative opinion for the use of Swiss drug major Novartis’ serelaxin (RLX030) in the treatment of acute heart failure, indicating that further evidence is required for a license to be granted in the European Union. 26 May 2014
Pharmaceutical
US drugmaker Ligand Pharmaceuticals has out-licensed rights to five programs to Viking Therapeutics, a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders. 23 May 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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze