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Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) said yesterday that the Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration voted unanimously (16 to 0) to recommend approval of the firm's blockbuster cholesterol lowerer Vytorin (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease. Merck's shares edged nearly 1% higher to $34.19 on the news in November 2 New York trading. 4 November 2011
Pharmaceutical
Byetta (exenatide), a drug which has been co-developed and now marketed by US biotech firm Amylin (Nasdaq: AMLN) and drug major Eli Lilly (NYSE: LLY) and commonly prescribed to help patients with type 2 diabetes improve blood sugar control, also has a powerful and rapid anti-inflammatory effect, a University at Buffalo, USA, study - funded by the two companies - has shown. 4 November 2011
Pharmaceutical
In final draft guidance published today (November 1), the UK's drug watchdog the National Institute of Health and Clinical Excellence (NICE) has recommended German independent drugmaker Boehringer Ingelheim's Pradaxa (dabigatran), in accordance with its licensed indications, for the prevention of stroke and systemic embolism in people with atrial fibrillation. 1 November 2011
Pharmaceutical
The UK's National Institute for Health and Clinical Excellence (NICE) issued two final guidances this morning, reversing a previous opinion on Japan largest pharma firm Takeda's Mepact (mifamurtide; The Pharma Letter October 8) and confirming its backing for National Health Service use of Anglo-Swedish drug major AstraZeneca's (LSE: AZN) blood thinner Brilique/Brilinta (ticagrelor; TPL September 16). 26 October 2011
Pharmaceutical
Data from eight countries shows that using Anglo-Swedish drug major AstraZeneca's (LSE: AZN) Brilique/Brilinta (ticagrelor) plus aspirin to treat acute coronary syndrome (ACS) patients for one year is associated with cost-savings, gain in quality-adjusted life years, and life-years gained compared to treatment with both generic and branded clopidogrel plus aspirin. 24 October 2011
Pharmaceutical
In a flurry of late news yesterday from the European Medicines Agency and its Committee for Medicinal Products for Human Use (CHMP), the advisory group said it has reviewed the possible link between the use of angiotensin II receptor antagonists (ARBs) and the occurrence of new cancers, concluding that the evidence does not support any increased risk of cancer in patients using these medicines. 21 October 2011
Pharmaceutical
Treating patients with the new blood thinning medication dabigatran (German independent drug major Boehringer Ingelheim's recently approved Pradaxa), instead of warfarin results in significantly higher per patient costs and higher net costs per stroke avoided, according to a new study by US pharmacy benefit manager Prime Therapeutics. 20 October 2011
Pharmaceutical
The atrial fibrillation drug market will increase nearly eight-fold over the next decade, growing from $1.3 billion in 2010 to more than $10 billion in 2020 in the leading markets of the USA, France, Germany, Italy, Spain, the UK and Japan, according to the findings of advisory firm Decision Resources. The launch and rapid uptake of new oral anticoagulants, atrial-selective antiarrhythmic drugs and the expanding prevalent patient population will be the key drivers of market growth, it says. 20 October 2011
Pharmaceutical
Laboratoires Servier , France's largest independent drugmaker has entered into a research, development and commercialization deal with USA-based Miragen Therapeutics, a preclinical-stage biopharmaceutical company focused on improving patients' lives by developing innovative microRNA (miRNA)-based therapeutics for cardiovascular and muscle disease, for three drug candidates, including two of miRagen's lead programs (miR-208 and miR-15/195) and one additional target yet to be identified, for cardiovascular disease. 20 October 2011
Pharmaceutical
The uptake of oral agents with novel modes of action such as AstraZeneca's ADP receptor antagonist Brilinta/Brilique (ticagrelor will drive sales in the 12-month post-hospital acute coronary syndrome (ACS) drug market to reach about $2.8 billion in 2020 in the USA, France, Germany, Italy, Spain, the UK and Japan, according to a new report from advisory firm Decision Resources. 18 October 2011
Biotechnology
Cardiovascular disease is the most common cause of death in Germany, with 60,000 people dying of a heart attack every year. So developing drugs to prolong the lives or improve the quality of life of patients with heart disease is a top priority for the pharmaceutical industry, says Birgit Fischer, director general of the German pharma association VFA. 13 October 2011
Pharmaceutical
Kuwait University revealed that it has signed a scientific cooperation agreement with Anglo-Swedish drug major AstraZeneca's (LSE: AZN) local subsidiary to conduct research on coronary arteries diseases in several Gulf Arab states, reports the Kuwait news agency KUNA. 11 October 2011
Pharmaceutical
The US Food and Drug Administration on Friday approved the marketing of the first combination drug to treat type 2 diabetes and high cholesterol in one table- pharma giant Merck & Co's Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both. 10 October 2011
Generics
The US District of Massachusetts has granted a request by Momenta Pharmaceuticals (Nasdaq: MNTA) and partner Sandoz (the generics unit of Swiss drug major Novartis; NOVN: VX) for a temporary restraining order (TRO) preventing Watson Pharmaceuticals (NYSE: WPI) and Amphastar Pharmaceuticals from marketing or selling Amphastar's enoxaparin sodium injection product, a generic equivalent to French major Sanofi's (Euronext: SAN) Lovenox enoxaparin). 10 October 2011
Pharmaceutical
Scios, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has pleaded guilty tto a misdemeanor violation of the Food, Drug and Cosmetic Act (FDCA) for introducing into interstate commerce its heart failure drug, Natrecor (nesiritide), for a use that was not approved by the Food and Drug Administration the Justice Department announced. 7 October 2011
Pharmaceutical
The German reimbursement body, the Federal Joint Committee (G-BA), has published the Institute for Quality and Efficiency in Healthcare (IQWiG) preliminary assessment report regarding the medical benefit of Anglo-Swedish drug major AstraZeneca's (LSE: AZN) clot buster Brilique (ticagrelor; also sold as Brilinta). 5 October 2011
Generics
The Italian subsidiaries of Japanese drug major Daiichi Sankyo (TYO: 4568) and its majority-owned India-based Ranbaxy (RANB: BO) have entered into a partnership to leverage Ranbaxy's distribution strengths and extensive relationships with pharmacists across Italy, for the distribution of Daiichi Sankyo products. 5 October 2011
Pharmaceutical
French drugmaker Ipsen (Euronext: IPN) and its partner, privately-held Inspiration Biopharmaceuticals say that the European Medicines Agency has validated and accepted the filing of the Marketing Authorization Application (MAA) for Inspiration's IB1001, a recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with hemophilia B. 3 October 2011
Pharmaceutical
Most drug therapy interventions for people with autism have targeted psychiatric problems, including aggression, anxiety and obsessive behavior. Now, University of Missouri researchers are examining the use of propranolol (a drug used to treat high blood pressure and control heart rate as well as to reduce test anxiety, originally Wyeth's Inderal brand which is now off patent) to improve the primary traits associated with autism ' difficulty with normal social skills, language and repetitive behaviors. MU researchers say the drug is a promising new avenue for improving language and social function. 2 October 2011
Pharmaceutical
Japanese drug major Astellas Pharma (TYO: 4503) says it has decided to discontinue the global development of darexaban maleate (development code name: YM150), an oral direct Factor Xa inhibitor for all indications. 29 September 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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