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Biotechnology
German drug major Bayer Schering Pharma has withdrawn its application for a centralized marketing authorization for the medicine Recothrom (thrombin alfa) 1,000 IU/ml, which was submitted to the European Medicines Agency (EMEA) in August 2008. 16 December 2009
Pharmaceutical
As a result of the launches of several new agents, the atrial fibrillation drug market will increase more than sevenfold from $790 million in 2008 to $6.1 billion in 2018 in the USA, France, Germany, Italy, Spain, the UK and Japan, according to a new report from research and advisory firm Decision Resources. 16 December 2009
Pharmaceutical
A US Food and Drug Administration medical reviewer has said the benefit of treating additional patients with Anglo-Swedish drug major AstraZeneca's cholesterol-lowerer Crestor (rosuvastatin) outweigh the drug's risks, according to press reports. However, the reviewer said additional study is needed to "further define this benefit-risk ratio." 14 December 2009
Generics
Generic erosion of premium-priced branded agents will offset sales of new agents and will cause the acute coronary syndrome market for drugs in the hospital setting to decrease from $800 million in 2008 to $729 million in 2018 in the USA, France, Germany, Italy, Spain, the UK and Japan, says a new report from research and advisory firm Decision Resources. 8 December 2009
Pharmaceutical
German drug major Bayer announced over the weekend details of data from the EINSTEIN Extension study for Xarelto (rivaroxaban), under development with US health care giant Johnson & Johnson, due to be presented at the American Society of Hematology in New Orleans conference on December 8. 7 December 2009
Pharmaceutical
Research presented yesterday at the 51st Annual Meeting of the American Society of Hematology, now taking place in New Orleans, reveals that the practice of using the anticoagulants aspirin and heparin with the hope of preventing clots in placental blood vessels is ineffective for stopping unexplained, recurrent miscarriages. Two other studies look at treatments for venous thromboembolism, a common and sometimes deadly clotting disorder. 7 December 2009
Pharmaceutical
US drug majors Bristol-Myers Squibb and Pfizer are planning to submit a European application for regulatory approval of apixaban for the prevention of venous thromboembolism (VTE) after orthopedic surgery in the first half of 2010. 7 December 2009
Pharmaceutical
New Jersey, USA-based drugmaker The Medicines Company has received European Union approval for the use of Angiox (bivalirudin) as an anticoagulant in patients with heart attacks (so-called ST-segment elevation myocardial infarction; STEMI) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI). 2 December 2009
Generics
In a filing with the US Securities and Exchange Commission, health care giant Abbott Laboratories revealed it has entered into a license agreement with Teva Pharmaceuticals USA granting the Israeli firm's local subsidiary rights to intellectual property for Tricor (fenofibrate) 145mg no sooner than March 28, 2011. Under certain defined circumstances, Teva may not receive rights to this intellectual property until July 1, 2012. 1 December 2009
Pharmaceutical
Drug major Sanofi-Aventis was in the news on two fronts: it has received final approval to market its arrhythmia drug Multaq (dronedarone) in the European Union and has signed a memorandum of understanding with Prominvest, a wholly-owned subsidiary of the Russian state corporation Rostekhnologii, confirming its intent to participate in the 'Pharmpolis Project' using the French company's new modern insulin factory located in Russia as a pilot initiative. 30 November 2009
Pharmaceutical
Independent German drug major Boehringer Ingelheim says that the European Commission has approved Micardis (telmisartan) for the reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus with documented target organ damage. 30 November 2009
Pharmaceutical
US FDA clears new indications for B-MS/Otsuka's Abilify and Pfizer's Geodon 23 November 2009
Pharmaceutical
Anglo-Swedish drug major AstraZeneca announced the results of the Phase II studies, ONSET/OFFSET and RESPOND for ticagrelor (trade name Brilinta) at the annual American Heart Association Scientific Sessions in Orlando, Florida, with the first study's results being simultaneously published in the medical journal Circulation. The company has also filed for approval of the drug in the USA. 19 November 2009
Pharmaceutical
An incorrect story was posted on The Pharma Letter web site yesterday regarding a clinical trial presented at the American heart Association meeting in Orlando, Florida. The article stated that a study on the drug anacetrapib was presented by the German firm Merck KGaA, while in fact it was from US pharmaceutical giant Merck & Co. We apologise for the mistake, which has been rectified in the story now viewable on our site. 19 November 2009
Pharmaceutical
The US Food and Drug Administration has notified health care professionals of what it says is new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid. New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced by almost half; the effectiveness of clopidogrel is reduced by 45% with the effect of the drug on platelets reduced by as much as 47%. 18 November 2009
Pharmaceutical
A new analysis of 6,801 women in the JUPITER study, presented at the American Heart Association Annual Scientific Sessions in Orlando, Florida, showed that Anglo-Swedish drug major AstraZenca's Crestor (rosuvastatin) 20mg significantly reduced cardiovascular (CV) events (defined as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by nearly half (46%; p=0.002 versus placebo) in women without cardiovascular disease (CVD), but at increased risk of a cardiovascular event as identified by age and elevated high-sensitivity C-reactive protein (hsCRP). This analysis also showed a 42% reduction in CV events for men (p<0.001 vs placebo). 18 November 2009
Biotechnology
November 18, 2009
Sales of agents to treat acute ischemic stroke will remain relatively flat over the next decade, increasing from $360 million in 2008 to $450 million in 2018 in the USA, France, Germany, Italy, Spain, the UK and Japan, says research and advisory firm Decision Resources. 18 November 2009
Pharmaceutical
USA-based Merck & Co, now the world's number two drugmaker following its acquisition of Schering-Plough, says it remains confident about the safety and efficacy of its leading cholesterol-lowering drugs, despite the results of a much-anticipated head-to-head study which calls into question the level of effectiveness of Zetia (ezetimibe) and Vytorin. (ezetimibe and simvastatin). 16 November 2009
Pharmaceutical
Simcere Pharmaceutical, a leading Chinese drugmaker specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals, has announced an agreement to acquire the manufacturing license in China for the blockbuster cholesterol drug rosuvastatin from Tianjin Tianda Pharmaceutical. 10 November 2009
Pharmaceutical
Although statins are widely used to prevent heart attacks, strokes, and other cardiovascular disorders, new research shows that the class of drugs may actually have negative effects on some cardiac patients. A new study presented at CHEST 2009, the 75th annual international scientific assembly of the American College of Chest Physicians (ACCP), found that statins have beneficial effects on patients with systolic heart failure (SHF), but those with diastolic heart failure (DHF) experienced the opposite effect, including increased dyspnea, fatigue, and decreased exercise tolerance. 5 November 2009
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
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
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