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Pharmaceutical
Following a positive recommendation from its drug advisory body (The Pharma Letter March 21), the European Commission has approved Eliquis (apixaban) in the 27 countries of the European Union for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. 23 May 2011
Pharmaceutical
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee to review the results of the ACCORD Lipid study as they relate to the use of fenofibric acid (sold as Trilipix in the USA by health care major Abbott Laboratories [NYSE: ABT]) in combination with a statin in patients with mixed dyslipidemia and at high risk of heart disease. 20 May 2011
Pharmaceutical
Following its expected launch in the USA in 2012 for venous thromboembolism (VTE) prophylaxis in medically ill patients, the overall uptake of German drug major Bayer (BAY: DE) and Johnson & Johnson (NYSE: JNJ) unit Ortho-McNeil's Xarelto (rivaroxaban) could be constrained in this indication by a perception of an increased risk of bleeding, says advisory firm Decision Resources. Nonetheless Xarelto will achieve blockbuster potential in the world's major pharmaceutical markets, it adds. 17 May 2011
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday announced three items of news regarding its potential blockbuster blood thinner Brilique/Brilinta (ticagrelor), which late last year gained European Marketing approval (The Pharma Letter December 6, 2010) but is still awaiting clearance in the all-important US market. 10 May 2011
Pharmaceutical
talian drugmaker Recordati SpA (REC: MI) has presented results for the first quarter of 2011 and its updated 2011-2013 Business Plan, which was approved by the board of directors. Consolidated revenue in the first quarter was 197.8 million euros ($286.9 million), up 6.4% compared to the same period of the preceding year, despite sales of its lead product, the antihypertensive Zanidip/Lercadip (lercanidipine) falling by 19.7% as a result of the entry of generics into the market following this product's patent expiry in January 2010. 10 May 2011
Pharmaceutical
US drugs behemoth Pfizer (NYSE: PFE) yesterday revealed that Revatio (sildenafil citrate, which is also the active ingredient of its erectile dysfunction drug Viagra) has been approved by the European Commission for the treatment of pediatric patients aged one to 17 years old with pulmonary arterial hypertension. 6 May 2011
Biotechnology
Switzerland-based Actelion (SIX: ATLN) today commented on the verdict issued with regard to Japan's Asahi Kasei Pharma Corp versus Actelion et al (case number CIV 478533, Superior Court of the State of California, County of San Mateo) (the matter) in which the jury last week awarded Asahi up to $547 million in compensatory damages. 4 May 2011
Pharmaceutical
Swiss drug major Novartis (NOVN: VX) says that Rasilamlo, a single-pill combination of aliskiren and amlodipine, has received approval from the European Commission (EC) for the treatment of high blood pressure patients not controlled by either aliskiren or amlodipine alone. 29 April 2011
Pharmaceutical
Sweden's Karo Bio AB (STO KARO) and Indian drugmaker Alkem Laboratories have entered into a collaboration and license agreement regarding eprotirome, which is currently in late-stage clinical testing for dyslipidemia. 28 April 2011
Biotechnology
There was mixed news this morning from the UK's drug rationing body the National Institute for Health and Clinical Excellence (NICE) for US biotechnology giant Amgen (Nasdaq: AMGN) and Spain's PharmaMar, a subsidiary of Zeltia (ZEL: MC). 27 April 2011
Generics
Indian drugmaker Lupin (LOPN: BO) yesterday announced via a filing with the Bombay stock exchange that it has entered into a licensing pact for various patents of the cholesterol lowerer drug Antara (fenofibrate) with US health care major Abbott Laboratories (NYSE: ABT) and French independent drugmaker Laboratoires Fournier SA. 27 April 2011
Pharmaceutical
Japanese drug major Daiichi Sankyo (TYO: 4568) has received its first marketing approval for Lixiana (edoxaban tosilate Hydrate, INN: edoxaban) from the Ministry of Health, Labor and Welfare in Japan. 26 April 2011
Pharmaceutical
US drugmaker Forest Laboratories (NYSE: FRX) reported that, for its fiscal fourth quarter ended March 31, reported net income was $322.5 million, or earnings per share of $1.12. Net sales for the quarter increased 9.7% to $1,091.9 million, from $995.6 million in the year-ago period. Analysts expected a profit of $1.06 per share and $1.11 billion in revenue, according to FactSet. 21 April 2011
Pharmaceutical
With the aim of expanding its drug delivery offerings, USA-based drugs and medical device maker Baxter International (NYSE: BAX) says it has entered into a definitive agreement to acquire privately-held Prism Pharmaceuticals, a specialty pharmaceutical company based in King of Prussia, Pennsylvania. 20 April 2011
Pharmaceutical
Following US Food and Drug Administration earlier this year, Japan's largest drugmaker, Takeda Pharmaceutical (4502:TYO), says that its Edarbi (azilsartan medoxomil), an angiotensin II receptor blocker (ARB) approved for the treatment of hypertension, is now available by prescription for adults in US pharmacies (The Pharma Letter February 28). 18 April 2011
Pharmaceutical
Final draft guidance published last week by the UK drug rationing body the National Institute for Health and Clinical Excellence (NICE) confirms its previous positive draft recommendation for naftidrofuryl oxalate as an option to treat people who suffer from intermittent claudication caused by peripheral arterial disease and for whom vasodilator therapy is considered appropriate after taking into account other treatment options. 18 April 2011
Generics
Jordan-headquartered generic drugmaker Hikma Pharmaceuticals (LSE: HIK) revealed on Friday that it has agreed to acquire a minority interest - thought to be less than 25% - in Unimark Remedies through the subscription of new equity for a cash consideration of $33.3 million. 18 April 2011
Pharmaceutical
German drug major Bayer (BYA: DE) says it has filed for approval of its blood thinner Xarelto (rivaroxaban) as a prevention of stroke in patients with atrial fibrillation with the Japanese Ministry of Health, Labor and Welfare (MHLW). 15 April 2011
Pharmaceutical
German drug major Bayer (BAY: DE) earlier this week presented mixed data regarding its blood thinner Xarelto (rivaroxaban) for preventing venous thromboembolism (VTE) in hospitalized ill patients. Data from the late-stage study (MAGELLAN: n= 8,101) were presented at the annual meeting of the American College of Cardiology. Xarelto has been co-developed with US drug major Johnson & Johnson (NYSE: JNJ). 8 April 2011
Pharmaceutical
USA-based Vivus (Nasdaq: VVUS), which is still struggling to get US Food and Drug Administration of its obesity drug candidate Qnexa (phentermine/topiramate; The Pharma Letter January 24), has announced long-term data that demonstrated patients treated with the investigational drug for two years showed reductions in blood pressure and the use of antihypertensive medications as well as improvements in lipid levels following significant reductions in weight loss as compared to those in the placebo group over two years. 5 April 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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