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Pharmaceutical
Danish insulin giant Novo Nordisk (NOVN: NV) revealed on December 15 that the Japanese Ministry of Health, Labor and Welfare has approved the firm's Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes. 27 December 2012
Pharmaceutical
The European Medicines Agency said on December 21 that it has started a review of the safety and efficacy of US pharma giant Merck & Co's (NYSE: MRK) Tredaptive, Pelzont and Trevaclyn, identical medicines containing the active ingredients nicotinic acid and laropiprant that are used to treat adults with dyslipidemia (abnormally high levels of fat in the blood), particularly combined mixed dyslipidemia and primary hypercholesterolemia. 24 December 2012
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) said yesterday that, following disappointing clinical trial results with its cholesterol drug Tredaptive (modified-release nicotinic acid/laropiprant), it does not plan to seek regulatory approval of the product in the USA. Merck's shares fell almost 3% to $42.35 by early afternoon yesterday. 21 December 2012
Pharmaceutical
The US subsidiary of German independent drug major Boehringer Ingelheim says that the US prescribing information for its blood thinner Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement. 21 December 2012
Pharmaceutical
The Brazilian market for atrial fibrillation will increase at a rate of 31% per year from 2011 to 2016, according to health care advisory firm Decision Resources' The Emerging Markets report titled Atrial Fibrillation in Brazil, which finds that this dramatic growth will be fueled by an increased drug-treated population and the proliferation of treatment alternatives for stroke prophylaxis in atrial fibrillation. 19 December 2012
Pharmaceutical
A report into anticoagulation therapies released yesterday by Australian Minister for Health Tanya Plibersek found more work was needed before new oral anticoagulants (NOACs) such as Pradaxa (dabigatran), from Independent German drug major Boehringer Ingelheim, could be listed on the Pharmaceutical Benefits Scheme (PBS). 19 December 2012
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) announced yesterday that a combined panel of experts from the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) have updated their guidelines to include a Class I recommendation for use of the oral antiplatelet (OAP) medicine Brilinta (ticagrelor) tablets in patients with ST-elevation myocardial infarction (STEMI) managed invasively. 18 December 2012
Pharmaceutical
US drug major Bristol-Myers Squibb (NYSE: BMY) and partner global pharma behemoth Pfizer (NYSE: PFE) yesterday announced the UK availability of their oral anticoagulant Eliquis (apixaban), marking the first European launch of the drug, which will be rolled out in other markets over the next few months, a company spokeswoman told The Pharma Letter. 14 December 2012
Biotechnology
During the 54th Annual Meeting of the American Society of Hematology (ASH) now taking place in Atlanta, USA, drug majors Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE announced the results of the Phase III AMPLIFY-EXT trial, which evaluated treatment with Eliquis (apixaban) showing the drug helped prevent blood clots in the legs and lungs and kept them from recurring. 11 December 2012
Pharmaceutical
The USA's Arena Pharmaceuticals (Nasdaq: ARNA) has entered into a co-development and license agreement with South Korea's Ildong Pharmaceutical for temanogrel, Arena's internally discovered inverse agonist of the serotonin 2A receptor. 28 November 2012
Biotechnology
Belgian biotechnology company Cardio3 BioSciences (C3BS) says it has received authorization from the Belgian Federal Agency for Medicines and Health Products (FAMHP) to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C3BS-CQR-1 in Belgium. 23 November 2012
Pharmaceutical
California, USA-based XOMA Corp (Nasdaq: XOMA) says the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) has demonstrated the fixed-dose combination (FDC) of perindopril arginine combined with amlodipine besylate is statistically significantly superior to either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. 23 November 2012
Pharmaceutical
US drug major Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE), the world's largest drugmaker by sales, have gained European Commission approval for Eliquis (apixaban) for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors. 22 November 2012
Pharmaceutical
The market shares of low-molecular-weight heparins and vitamin K antagonists continue to be gradually eroded by the uptake of novel oral anticoagulants in Europe for venous thromboembolism (VTE) prevention after orthopedic surgery, according to a new report from health c are advisory firm Decision Resources. 21 November 2012
Pharmaceutical
Following swiftly on similar news from the US Food and Drug Administration, German drug major Bayer (BAYN: DE) has gained European Commission approval for its oral anticoagulant Xarelto (rivaroxaban) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. This approval makes rivaroxaban the only novel oral anticoagulant approved in this indication in the European Union. 21 November 2012
Pharmaceutical
Swedish mitochondrial medicine firm NeuroVive has announced a collaboration with China's Sihuan Pharmaceutical Holdings (HKEx: 0460) for the development and commercialization in China of NeuroVive's most clinically advanced products CicloMulsion (cyclosporine) and NeuroSTAT. 21 November 2012
Pharmaceutical
German drug major Bayer (BAYN: DE) has initiated the Phase III COMPASS study of its oral anticoagulant Xarelto (rivaroxaban) for investigating the secondary prevention of major adverse cardiac events including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or peripheral artery disease. The study expects to enroll about 20,000 patients in more than 450 sites across >25 countries worldwide. 14 November 2012
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) said last evening that the Federal Patent Court in Germany has found the formulation patent protecting its schizophrenia drug Seroquel XR (quetiapine fumarate) prolonged-release tablets - marketed as Seroquel Prolong in Germany - to be invalid. 14 November 2012
Pharmaceutical
The atrial fibrillation drug market will experience dramatic growth over the next decade, increasing from $2.7 billion in 2011 to $9.2 billion in 2021 in the USA, France, Germany, Italy, Spain, the UK and Japan, according to health are advisory firm Decision Resources. 13 November 2012
Biotechnology
US specialty drugmaker Auxilium Pharmaceuticals' (Nasdaq: AUXL) shares fell 7.2% to $18.60 at close of New York trading yesterday, after the company revealed that drugs behemoth Pfizer (NYSE: PFE) has terminated its collaboration agreement for the development, commercialization and supply of the Dupuytren's contracture treatment Xiapex (collagenase clostridium histolyticum), in the European Union and certain other European and Eurasian countries, effective no later than April 24, 2013. 8 November 2012
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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