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Pharmaceutical
Norway-based lipid therapies specialist Pronova BioPharma says that its partner, Takeda Pharmaceutical (TYO: 4502), has submitted a New Drug Application to the Japanese Ministry of Health, Labour and Welfare for TAK-085 (generic name: omega-3-acid ethyl esters 90) for the treatment of hyperlipidemia, high blood cholesterol. 29 September 2011
Biotechnology
US biotech firm InterMune (Nasdaq: ITMN) has reported that new data at the European Respiratory Society (ERS) Annual Congress supporting the longer-term safety and tolerability of Esbriet (pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF), a devastating lung disease. 26 September 2011
Pharmaceutical
There was more good news for Bayer HealthCare, the pharma unit of Germany's Bayer AG (BAY: DE), when the European Committee for Medicinal Products for Human Use (CHMP) on Friday recommended its oral anticoagulant Xarelto (rivaroxaban) for both the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF), as well as for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults. 26 September 2011
Pharmaceutical
Swiss drug major Novartis (NOVN: VX) yesterday announced new data today at the European Respiratory Society (ERS) congress on the pivotal Phase III IMPRES clinical trial showing that the investigational therapy QTI571 (imatinib) significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH) compared with placebo. 26 September 2011
Pharmaceutical
There was mixed news for French drug major Sanofi (Euronext: SAN) yesterday, when the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended restricting the use of Multaq (dronedarone) due to adverse events, but said the benefit-risk balance of the drug remains positive in a limited population of patients with paroxysmal or persistent atrial fibrillation. 23 September 2011
Pharmaceutical
US drug major Bristol-Myers Squibb (NYSE: BMY) revealed yesterday that it has teamed up with privately-held California-based Ambrx for the development of new treatments in the field of diabetes and heart failure, paying an upfront $24 million to the biopharma firm. 23 September 2011
Pharmaceutical
US drug majors Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) say that their Eliquis (apixaban), an oral treatment, is now available in the UK for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or knee replacement surgery. 21 September 2011
Generics
There was good and bad news for French drug major Sanofi (Euronext: SAN) yesterday, when the US District Court for the District of New Jersey ruled against Indian generic drugmaker Sun Pharmaceuticals with respect to a contractual dispute arising from the resolution of the Eloxatin (oxaliplatin) patent litigation. However, the US Food and Drug Administration also approved a second generic version of the French group's blockbuster blood thinner Lovenox (enoxaparin). 20 September 2011
Pharmaceutical
In final draft guidance published today, the UK drugs watchdog the National Institute of Health and Clinical Excellence (NICE) has confirmed its previous positive draft recommendation for Anglo-Swedish drug major AstraZeneca's Brilique (ticagrelor; also sold as Brilinta). The draft guidance recommends use on the National Health Service of ticagrelor within its licensed conditions (that is, in combination with aspirin and for up to 12 months) as an option to treat adults with acute coronary syndromes (ACS). 16 September 2011
Pharmaceutical
There must have been a palpable sigh of relief last night across Leverkusen, the headquarters of Germany's Bayer AG (BAY: DE), when the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee recommended approval of the company's Xarelto (rivaroxaban) for the expanded indication of the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) in the USA. 9 September 2011
Pharmaceutical
US Food and Drug Administration staffers posted a negative picture for German drug major Bayer (BAY: DE) and US partner Johnson & Johnson's (NYSE: JNJ) ahead of the September 8 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss the New Drug Application for their Xarelto (rivaroxaban) tablets, for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with non-valvular atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart). 7 September 2011
Pharmaceutical
There was a big disappointment for Anglo-Swedish drug major AstraZeneca (LSE: AZN) on Friday, when it revealed results of a new study that failed to show its drug Crestor (rosuvastatin) was a significant improvement over US behemoth Pfizer's (NYSE: PFE) all-time blockbuster cholesterol lowerer Lipitor (atorvastatin), sending the London-headquartered firm's down 3.5% to 28.13 by close of trading that day. 5 September 2011
Generics
Global drugs behemoth Pfizer (NYSE: PFE) has reached agreement with French drug major Sanofi (Euronext: SAN) for the latter to make a generic of its all-time blockbuster cholesterol lowerer Lipitor (atorvastatin), which - despite the advent of generic competition in some markets - last year still generated revenues of $11 billion, but which will lose patent protection in the all important US market at the end of November this year. 1 September 2011
Pharmaceutical
A Phase II dose-finding study has found that the new oral Factor Xa inhibitor darexaban, under development by Japanese drug major Astellas Pharma (TYO:4503) was associated with a two to four-fold increase in bleeding when added to dual antiplatelet therapy in patients following an acute coronary syndrome. 1 September 2011
Pharmaceutical
In much anticipated research news, US drug majors Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) have now announced the main results of the Phase III clinical trial ARISTOTLE, which evaluated Eliquis (apixaban) compared to warfarin for the prevention of stroke or systemic embolism in 18,201 patients with atrial fibrillation and at least one risk factor for stroke, with the findings exceeding already high expectations. 30 August 2011
Pharmaceutical
There was good news for Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday, when the firm revealed positive results relating to its anticoagulant Brilinta (ticagrelor) from a blinded review of clinical data from patients in the PLATO trial who had died following coronary artery bypass graft (CABG) surgery. 30 August 2011
Pharmaceutical
Anglo-Swedish pharmaceutical major AstraZeneca (LSE: AZN) said yesterday that Brilinta (ticagrelor) tablets, a new oral antiplatelet therapy, is now available in pharmacies in the USA. 23 August 2011
Pharmaceutical
An abstract summarizing partial results from the Phase II dal-PLAQUE trial with Swiss drug major Roche's (ROG: SIX) dalcetrapib has been released ahead of the European Society of Cardiology (ESC) 2011 conference (August 27-31 in Paris). 22 August 2011
Pharmaceutical
A new drug which offers a radically different approach to treating certain types of heart failure has been shown to improve cardiac function in heart failure patients in its first clinical trials, report UK researchers. 21 August 2011
Pharmaceutical
Italian drug developer Gentium SpA (Nasdaq: GENT) saw its shares price plunge 29% to $6.22 on the Nasdaq after it announced that it has voluntarily withdrawn the New Drug Application for its lead investigational drug candidate defibrotide following recent correspondence from the US Food and Drug Administration identifying numerous 'Refuse to File' issues regarding the company's NDA submission. 19 August 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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