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Pharmaceutical
Stockholm-based Swedish Orphan Biovitrum (STO: SOBI) has signed a global licensing agreement with the French company Only for Children Pharmaceuticals (O4CP) regarding bumetanide reformulated for the treatment of diuresis and seizures in neonates. 16 January 2012
Pharmaceutical
Researchers at St Michael's Hospital in Toronto, Canada, have published the first detailed figures showing the risk of using Swiss drug major Novartis' (NOVN: VX) prescription drug Rasilez (aliskiren), a renin inhibitor licensed for the treatment of essential hypertension, in combination with certain other blood pressure-lowering medications. 15 January 2012
Pharmaceutical
In preliminary recommendations published yesterday (January 9) the UK's drugs watchdog the National Institute for Clinical Health and Excellence (NICE) is asking German drug major Bayer HealthCare (BAY: DE) for more information on its oral anticoagulant Xarelto (rivaroxaban) for the prevention of stroke and systemic embolism in people with atrial fibrillation. 10 January 2012
Biotechnology
Russia's RusNano (Russian Corporation of Nanotechnologies) has signed an agreement with Russian biotechnology company Epidbiomed to establish a joint venture for the production of drugs with nano particles of porous silicon and other nanomaterials. 9 January 2012
Pharmaceutical
Now global pharma behemoth Pfizer (NYSE: PFE) spent $114 billion in 2000 for a hostile takeover of Warner-Lambert, trumping American Home Products in a bidding war to acquire the $130 billion in sales of all-time blockbuster drug, the cholesterol lowerer Lipitor (atorvastatin) delivered during its 14 years on the market, which came to its fabled end on November 30, 2011. 5 January 2012
Pharmaceutical
US specialty drugmaker Cornerstone Therapeutics (Nasdaq: CRTX) said yesterday that it has acquired Cardiokine, a privately-held specialty pharmaceutical company focused on developing hospital products for cardiovascular indications. The merger, financial terms of which were not revealed, was effective December 30, 2011, said Cornerstone. 4 January 2012
Biotechnology
US health care giant Johnson & Johnson's (NYSE: JNJ) Janssen Research & Development, has submitted a supplemental New Drug Application to the US Food and Drug Administration seeking approval for the use of Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of (thrombotic) cardiovascular events in patients with acute coronary syndrome (ACS), under a commercialization deal with Germany's Bayer (BAY: DE). 30 December 2011
Pharmaceutical
The European Medicines Agency is reviewing aliskiren-containing medicines, approved for the treatment of essential hypertension, to assess the impact of data coming from the ALTITUDE study on the balance of benefits and risks of these medicines in their approved indication. 23 December 2011
Pharmaceutical
The US Food and Drug Administration yesterday approved Edarbyclor (azilsartan medoxomil and chlorthalidone) a combination therapy from Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) for the treatment of hypertension to lower blood pressure in adults. 21 December 2011
Pharmaceutical
German drugs and crop and material sciences group Bayer (BAT: DE) said yesterday that it plans to continue investing heavily in R&D and expects its Pharmaceuticals business in particular to generate substantial sales with the new products that are scheduled to be launched in the next 18 months, which could potentially add some $6.5 billion to the company's revenues. 21 December 2011
Pharmaceutical
In a major disappointment for Swiss drug major Novartis (NOVN: VX), the company says that, following the seventh interim review of data from the ALTITUDE study with Rasilez/Tekturna (aliskiren), it has decided to terminate the trial in high-risk patients with diabetes and renal impairment on the recommendation of the independent Data Monitoring Committee (DMC) overseeing the trial. 21 December 2011
Pharmaceutical
The European Commission has approved two new indications for German drug major Bayer HealthCare's (BAY: DE) Xarelto (rivaroxaban), making it the only new oral anticoagulant approved in three indications across all 27 European Union member states for: ' prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors;' treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults; and ' the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery. The move follows a European Medicines Agency advisory panel recommendation in the fall (The Pharma Letter September 26). 20 December 2011
Pharmaceutical
The US Food and Drug Administration (FDA) has completed a safety review of French drug major Sanofi's (Euronext: SAN) heart drug Multaq (dronedarone), concluding that the drug increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). 20 December 2011
Pharmaceutical
The German health assessment body, the Federal Joint Committee (G-BA), has issued its final decision regarding the medical benefit of Anglo-Swedish drug major AstraZeneca's (LSE: AZN) Brilique (ticagrelor, also marketed as Brilinta), giving the green light for the blood thinner, the first product to be reviewed under AMNOG (Arzneimittelmarkt-Neuordnungsgesetz), the new law that became effective January 1, 2011, for the mandatory pricing assessment for newly introduced drugs in the German health care system (The Pharma Letter October 5) . 16 December 2011
Pharmaceutical
California, USA-based Isis Pharmaceuticals (Nasdaq: ISIS) announced yesterday that there will be a slight delay in the submission of the New Drug Application to the US Food and Drug Administration for Kynamro (mipomersen sodium), a first-in-class apo-B synthesis inhibitor currently in late-stage development for the reduction of low-density lipoprotein cholesterol, which is partnered with Genzyme, now part of France's Sanofi (Euronext: SAN). 15 December 2011
Pharmaceutical
include a second collaboration in a different therapeutic area. Financial terms were not disclosed. 15 December 2011
Biotechnology
Israeli biopharma company BioLineRx (TASE: BLRX) has entered into a collaboration with fellow Israel-based Compugen (Nasdaq: CGEN) to develop and commercialize mutually selected Compugen-discovered drug candidates for the treatment of various diseases, ranging from acute and chronic inflammatory diseases through cardiac diseases, retinopathy and cancer. 14 December 2011
Pharmaceutical
Driven primarily by the launches and strong uptake of oral anticoagulants, the combined markets for drugs used in the treatment and prophylaxis of venous thromboembolism will experience moderate growth over the next decade, increasing from $3.4 billion in 2010 to $4.7 billion in 2020 in the leading markets of the USA, France, Germany, Italy, Spain, the UK and Japan, according to a new report from health care advisory firm Decision Resources. 14 December 2011
Pharmaceutical
In another piece of positive news for Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502), the company said last week that the European Commission has granted marketing authorization for Edarbi (azilsartan medoxomil), a new once-daily angiotensin receptor blocker (ARB) - also known as angiotensin II receptor antagonist (AIIRA) - for the treatment of essential hypertension in adults. 12 December 2011
Pharmaceutical
Post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate), a blood thinner from independent German drug major Boehringer Ingelheim, are being evaluated by the US Food and Drug Administration. 8 December 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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