Cardio-vascular
Refine Search
Pharmaceutical
GlobalData, the industry analysis specialist, has released its new report, titled Peripheral Arterial Disease (PAD) - Pipeline Assessment and Market Forecasts to 2017, showing that the global PAD therapeutics market accounted for approximately $606 million in 2009. In 2001, the market was valued at $405 million and it increased at an approximate compound annual growth rate (CAGR) of 5.2% between 2001 and 2009. 2 November 2010
Pharmaceutical
Not surprisingly given an earlier advisory panel recommendation (The Pharma Letter September 21), the US Food and Drug Administration yesterday approved independent German drug major Boehringer Ingelheim's Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). 20 October 2010
Biotechnology
A US Food and Drug Administration advisory panel has voted near unanimously that biotech major Amgen's (Nasdaq: AMGN) Aranesp (darbepoetin) and Epogen (epoetin alfa) and Johnson & Johnson's (NYSE: JNJ) Procrit (epoetin alfa) should remain on the market for anemia patients who do not yet require dialysis, despite an increased risk of stroke as identified in the TREAT clinical study. Amgen's stock rise 2.2% to $57.96 by 4pm after the recommendation. 19 October 2010
Generics
US drugmaker Mylan (Nasdaq: MYL) has received final approvals from the US Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for the generic versions of drug giant Merck & Co (NYSE: MRK) antihypertensives Hyzaar (losartan, potassium and hydrochlorothiazide) 50mg/12.5 mg and 100mg/25mg tablets, and Cozaar (losartan potassium) 25mg, 50mg and 100mg. 18 October 2010
Pharmaceutical
Aachen, Germany-based biopharmaceutical company PAION AG (FSE: PA8) has expanded its desmoteplase licence deal with existing partner Denmark's H Lundbeck A/S (LUND: DC) with which it has been collaborating on the ischemic stroke candidate since 2005. 18 October 2010
Generics
2011 is shaping up to be an interesting year in the Hatch-Waxman world, and all eyes seem to be focusing on what will happen with Ranbaxy's purported (sole) 180-day exclusivity for a generic version of the mega-blockbuster drug Lipitor (atorvastatin calcium) tablets marketed by the world's biggest drugmaker Pfizer, says US law firm Hyman, Phelps & McNamara's Kurt Karst writing on its FDA Law Blog. 14 October 2010
Pharmaceutical
Independent German drugmaker Boehringer Ingelheim announced yesterday that the European Commission confirmed the positive opinion of the European Medicines Agency (EMEA) on its combination blood pressure drug, approving Twynsta (telmisartan and amlodipine). The decision follows an approval recommendation for the EMEA's Committee for Medicinal Products for Human Use (CHMP) earlier this year (The Pharma Letter July 26). The drug has also been cleared by the US Food and Drug Administration (TPL October 20, 2009). 13 October 2010
Biotechnology
There was some good news for the German biotechnology industry this week. According to proposed changes to Germany's drug pricing reforms (The Pharma Letter October 1), orphan drugs will be exempt from a major change to the law that had threatened to undermine sales of small and medium-sized biotech firms, who are the principal producers of drugs for rare diseases. In Europe, a disease is deemed rare if no more than five in 10,000 patients suffer from it. 8 October 2010
Pharmaceutical
Aiming to provide added support for its blood thinner candidate, Anglo-Swedish drug major AstraZeneca(LSE: ANZ) plans to initiate a large, international, clinical outcomes study for the investigational oral antiplatelet ticagrelor (which uses the trade names Brilinta and Brilique) in collaboration with the US Brigham and Women's Hospital-based Thrombolysis in Myocardial Infarction (TIMI) Study Group. The PEGASUS-TIMI 54 study is scheduled to begin patient enrolment during the fourth quarter 2010. 4 October 2010
Pharmaceutical
Meeting highlights from the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) last week included good news for Anglo-Swedish drug maker AstraZeneca (LSE: ANZ) and Swiss major Novartis (NOVN: VX) but, as reported last Friday, not for GlaxoSmithKline, with the Agency calling for the suspension of its once blockbuster diabetes drug Avandia (rosiglitazone) and a negative take on Merck KGaA's cladribine for multiple sclerosis, which caused the latter's share price to tumble near 10% (The Pharma Letter September 24). 26 September 2010
Pharmaceutical
There was a big disappointment for French drug major Sanofi-Aventis (EURONEXT: SAN) when it had to announce yesterday that the Phase III TAMARIS trial evaluating the investigational angiogenic therapy NV1FGF (riferminogen pecaplasmid) did not meet its primary endpoint of restoring blood vessel growth in damaged limbs. 23 September 2010
Pharmaceutical
The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted unanimously (nine to zero) in favor of approving German independent drug major Boehringer Ingelheim's Pradaxa (dabigatran etexilate) for stroke prevention in patients with atrial fibrillation (AFib), putting the company ahead in the race to replace the long-used anticoagulant warfarin in the world's largest drug market. 21 September 2010
Biotechnology
USA-based biotech firm Chelsea Therapeutics International (Nasdaq: CHTP) says its shares leap nearly 40% to $6.96 in early trading yesterday, after the firm announced that preliminary analyses of its Phase III trial studying its lead compound Northera (droxidopa; Study 301) met its primary endpoint. 21 September 2010
Pharmaceutical
The European Medicines Agency (EMEA) has been formally notified by Swiss drug major Novartis (NOVN. VX) of its decision to withdraw its application for a centralized marketing authorization for Rasival, a combination of aliskiren (a direct renin inhibitor sold as Rasilez in Europe and Tekturna in the USA) and valsartan (the active ingredient of its blockbuster antihypertensive Diovan which loses patent protection in 2012 but generated sales of $1.55 billion in second-quarter 2010), 150/160mg and 300/320mg film-coated tablets. 20 September 2010
Pharmaceutical
The European Commission has approved an update to the Summary of Product Characteristics (SmPC) for independent German drug major Boehringer Ingelheim's Viramune (nevirapine) in the treatment of patients with HIV. The label change means that HIV-1 patients with an undetectable viral load can switch to treatment with Viramune regardless of their CD4 count. 17 September 2010
Pharmaceutical
The US Food and Drug Administration has extended the time to complete its review of the New Drug Application for Anglo-Swedish drug major AstraZeneca's (LSE: AZN) Brilinta (ticagrelor), the company announced. Earlier this year, an FDA advisory panel voted seven to one to recommend approval of the drug (The Pharma Letter July 29). 15 September 2010
Pharmaceutical
UK pharmaceutical giant GlaxoSmithKline (LSE: GSK) sustained a double dose of bad news yesterday, after the UK' drugs watchdog the National Institute for Health and Clinical Excellence (NICE) rejected approving the firm's Revolade (eltrombopag) for use under the National Health in England and Wales because it is too expesnive, and its antidepressant drug candidate, under development with the USA's Neurocrine Biosciences (Nasdaq: NBIX), failed in a Phase II study. 15 September 2010
Pharmaceutical
The domination of the antidyslipidemic - or cholesterol lowerers - market by five top brands is set to fundamentally change over the next 10 years as novel agents fail to meet the success of their predecessors, claims a new report from independent market analyst, Datamonitor. 15 September 2010
Pharmaceutical
Ireland-headquartered drugmaker Shire plc (LSE: SHP) says that the US Food and Drug Administration has posted an update on its web site related to ProAmatine (midodrine), a drug approved for the treatment of symptomatic orthostatic hypotension, which the company said it would withdraw from the US market after the agency called for additional clinical data that it claimed it has already submitted (The Pharma Letters August 19 and 17). 14 September 2010
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