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Biotechnology
UK government medicines cost-effectiveness body the National Institute for Health Care Excellence (NICE) has published new draft guidance recommending two new treatment options for suitable patients with conditions that put them at extremely high risk of heart attacks or strokes. 6 May 2016
Biotechnology
Stephen O’Hara is chief executive of OptiBiotix Health, a UK-based biotech which has been interesting big pharma recently with its Lactobacillus plantarum strain, a statin-free cholesterol pill. He spoke to the Pharma Letter... 4 May 2016
Pharmaceutical
The heart failure market is set to rise from around $3.2 billion in 2015 to $11.8 billion by 2025, representing a compound annual growth rate of 13.7%, new research indicates. 4 May 2016
Pharmaceutical
The US Food and Drug Administration has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor), from AstraZeneca. 3 May 2016
Generics
The US Food and Drug Administration on Friday approved the first generic version of Crestor (rosuvastatin calcium), a copy of Anglo-Swedish pharma major AstraZeneca’s blockbuster cholesterol drug that is facing patient expiries. 1 May 2016
Pharmaceutical
The US Food and Drug Administration has approved German pharma major Bayer’s Gadavist (gadobutrol) injection for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates). 30 April 2016
Pharmaceutical
In guidance published today, drug cost-effectiveness watchdog for England and Wales, the National Institute for Health and Clinical Excellence (NICE), has recommended that Swiss pharma giant Novartis’ new heart failure drug Entresto (sacubitril valsartan), the first drug of its kind, as an option for some people with heart failure. 27 April 2016
Biotechnology
UK biotech OptiBiotix has been in talks with big pharma about a cholesterol pill believed to work as well as statins, but without the side effects, according to reports. 26 April 2016
Biotechnology
Japan-based Amgen Astellas BioPharma and Astellas Pharma say that their proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha (evolocumab [genetically recombination] Injection) Syringe has become available in the Japanese market. 25 April 2016
Pharmaceutical
While Boehringer Ingelheim is still enjoying very strong sales of its chronic obstructive pulmonary disease drug Spiriva (tiotropium), the German privately-owned major is looking at diabetes as its next long-term growth driver. 20 April 2016
Pharmaceutical
Germany’s Boehringer Ingelheim and US pharma major Eli Lilly said today they plan to conduct two outcome trials investigating the diabetes medicine Jardiance (empagliflozin) for the treatment of people with chronic heart failure. 19 April 2016
Pharmaceutical
New data shows reduced risk of ischemic stroke and intracranial hemorrhage (ICH) among patients with non-valvular atrial fibrillation (AF) receiving German pharma major Bayer’s Xarelto (rivaroxaban), compared with those taking warfarin 18 April 2016
Pharmaceutical
Privately-held Servier has marked 40 years of operations in Brazil by announcing plans to launch 15 new meds not only for diabetes, but also for cancer and cardiovascular diseases – the country’s second biggest killers. 7 April 2016
Biotechnology
US biotech firm Amgen has released encouraging Phase III data on statin-intolerant patients with high cholesterol treated with Repatha (evolocumab). 4 April 2016
Biosimilars
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines, including one advanced therapy medicinal product (ATMP), for approval at its March meeting. 2 April 2016
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has welcomed a new treatment guideline which recommends its Brilinta (ticagrelor) over clopidogrel in acute coronary syndrome (ACS). 31 March 2016
Biotechnology
US biotech firm Portola Pharmaceutical saw its shares tumble on Thursday after Phase III clinical trial results of its oral blood thinner betrixaban missed study thresholds. 26 March 2016
Pharmaceutical
Commonly-used anti-depressants known as selective serotonin reuptake inhibitors (SSRIs) do not increase the risk of cardiovascular conditions among young and middle-aged people, a new study has revealed. 24 March 2016
Biotechnology
US biotech for Regeneron Pharmaceuticals and French pharma major Sanofi today released positive results from the Phase III ODYSSEY ESCAPE trial evaluating Praluent (alirocumab) injection in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH), whose cholesterol levels required chronic, weekly or bi-weekly apheresis therapy. 23 March 2016
Pharmaceutical
Anglo-Swedish pharma firm AstraZeneca has reported disappointing top-line results from the Socrates trial testing the efficacy of Brilinta (ticagrelor) tablets to prevent strokes. 23 March 2016
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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