Cardio-vascular
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Pharmaceutical
Dainippon Sumitomo Pharma (DSP; TYO: 4506) has entered into a license accord with fellow Japanese drugmaker Shionogi (TYO: 4507) for the co-marketing in Japan of DSP-8153, a combination product of the anti-hypertension drugs irbesartan and amlodipine besilate, for which DSP submitted an application for manufacturing and marketing approval to the Ministry of Health, Labor and Welfare in Japan last November. 11 June 2012
Biotechnology
Amgen (Nasdaq: AMGN), the world's largest independent biotech company, announced top-line results on Friday of the Phase III EVOLVE (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial, which evaluated Sensipar (cinacalcet, sold as Mimpara in Europe) for the reduction of the risk of mortality and cardiovascular (CV) events among 3,883 patients with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) receiving dialysis, which failed to meet its primary endpoint. 11 June 2012
Pharmaceutical
Independent German drug major Boehringer Ingelheim has updated the US prescribing information for Pradaxa (dabigatran etexilate) in alignment with the US Food and Drug Administration to affirm that "Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin." 7 June 2012
Generics
People taking the most commonly used generic and branded statins to control their cholesterol had similar observable rates of cardiovascular events, but their total treatment costs were as much as 30% higher with branded drugs, according to comparative effectiveness research presented at the annual international meeting of the International Society of Pharmacoeconomics and Outcomes Research. 5 June 2012
Pharmaceutical
European Union Ombudsman Nikiforos Diamandouros has called on the European Medicines Agency to increase the transparency of its procedures for ensuring that children can benefit from new medicines. 4 June 2012
Pharmaceutical
In final draft guidance published today (1 June 1), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has recommended German drug major Bayer's (BAYN: DE) Xarelto (rivaroxaban) as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism in adults diagnosed with acute deep vein thrombosis (DVT) on the National Health Service. 1 June 2012
Pharmaceutical
Presenting at the National Lipid Association's (NLA) Scientific Sessions in Scottsdale, Arizona, USA, Kowa Pharmaceuticals America, a subsidiary of privately owned Japanese firm Kowa, and US drug major Eli Lilly (NYSE: LLY) announced positive results of the PREVAIL US study (Pitavastatin compaREd with praVAstatin In Lowering LDL-C in the USA) which evaluated the efficacy of Livalo (pitavastatin) 4mg compared with pravastatin 40mg in reducing low-density lipoprotein cholesterol (LDL-C), the primary endpoint, as well as effects on other lipid parameters and lipoprotein particles in adult patients with primary hyperlipidemia or mixed dyslipidemia. 1 June 2012
Biotechnology
The US Food and Drug Administration has accepted for filing the New Drug Application for Kynamro (mipomersen sodium), under development by French drug major Sanofi's (Euronext: SAN) Genzyme subsidiary and Isis Pharmaceuticals (Nasdaq: ISIS) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The NDA filing with the FDA triggers a $25 million milestone payment to Isis from Genzyme. 31 May 2012
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) which has the marketing rights for Lovaza (omega-3-acid ethyl esters) in the USA and Puerto Rico, confirmed that US District Judge Sue Lewis Robinson, the presiding judge in the US District Court for the District of Delaware, ruled in Pronova BioPharma's (OSE: PRON.OL) favor in the latter's patent litigation involving US Patent Nos 5,656,667 and 5,502,077 covering Lovaza. 30 May 2012
Pharmaceutical
Data presented yesterday at the 2012 European Atherosclerosis Society (EAS) Congress in Milan, Italy, from the VOYAGER study demonstrate the benefits of aggressive statin therapy with Anglo-Swedish drug major AstraZeneca's (LSE: AZN) blockbuster cholesterol lowerer Crestor (rosuvastatin) in comparison to atorvastatin and simvastatin in high risk patients. 29 May 2012
Pharmaceutical
Independent German drug major Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY) have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending approval of their diabetes drug Jentadueto, which combines the DPP-4 inhibitor, linagliptin (the active ingredient in Trajenta) and metformin in a single tablet. 28 May 2012
Biotechnology
USA-based Regeneron (Nasdaq: REGN) and French drug major Sanofi (Euronext: SAN) presented results of their third and final Phase II study at the European Atherosclerosis Society (EAS) Congress in Milan, Italy, on May 26, adding to the recently presented results of the other two studies in patients with primary hypercholesterolemia, for their investigational cholesterol-lowering agent SAR236553/REGN727 which is part of a global development collaboration. 27 May 2012
Generics
The global generics market cardiovascular drugs is expected to grow rapidly due to the growing dyslipdemia, thrombosis and hypertension populations in the developed countries, as well as patent expiries of major blockbusters such as Lipitor (atorvastatin), Plavix (clopidogrel) and Diovan (valsartan), according to a new report for GBI Research. The patent expiries of these blockbuster drugs will trigger generic competition in the cardiovascular therapeutics market, making it more competitive. 27 May 2012
Pharmaceutical
Despite relatively positive briefing papers earlier this week (The Pharma Letter May 22), the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee yesterday voted six to four (with one abstention) against the approval of German drug major Bayer's (BAYN: DE) oral anticoagulant Xarelto (rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS). 24 May 2012
Pharmaceutical
There was good news today (May 23) for German drug major Bayer (BAYN: DE), when the UK's drug watchdog, the National Institute for Health and Clinical Excellence (NICE) published final guidance recommending National Health Service use of its anticoagulant Xarelto (rivaroxaban) as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation. 23 May 2012
Pharmaceutical
The US Food and Drug Administration advisory panelists due to revue Johnson & Johnson (NYSE: JNJ) and Bayer's (BAYN: DE) New Drug Application for their anticoagulant Xarelto (rivaroxaban) on Wednesday, have been issued with FDA staff briefing documents indicating that the drug should be cleared for the prevention of secondary cardiovascular events in patients with acute coronary syndrome (ACS). 22 May 2012
Generics
Coinciding with the loss of patent protection on Sanofi (Euronext: SAN) and Bristol-Myers Squibb's (NYSE: BMY) blockbuster blood thinner yesterday, the US Food and Drug Administration announced that it has approved several generic versions of Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries. 18 May 2012
Generics
GenericsWeb, a patent analysis and search company, recently published an article based on its proprietary Pipeline Patent Intelligence that analyses opportunities in launching generic versions of French drug major Sanofi (Euronext: SAN) and US partner Bristol Myers Squibb's (NYSE: BMY) blockbuster platelet aggregation inhibitor clopidogrel (brand names Plavix and Iscover). 17 May 2012
Pharmaceutical
In a second acquisition move within a matter of months, USA-based specialty drugmaker Cornerstone Therapeutics has made a takeover bid for EKR Therapeutics, a privately-held specialty pharmaceutical company focused on the acute-care hospital setting. 16 May 2012
Biotechnology
US biotech firm PolyMedix (OTCBB: PYMX) has issued an update on its anticoagulant reversing agent PMX-60056, saying it has stopped enrollment in two clinical trials for the compound, news which saw the company's shares plunge 39% to $0.36. 15 May 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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