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Biotechnology
USA-based Portola Pharmaceuticals saw its shares jump 7.2% to $40.83 after it announced positive results from a Phase III study of andexanet alfa, which is being developed as a anticoagulant antidote to German pharma major Bayer’s Xarelto (rivaroxaban). 2 March 2015
Biotechnology
German family-owned pharma major Boehringer Ingelheim has submitted a Biologics License Application (BLA) to the US Food and Drug Administration, requesting an Accelerated Approval pathway, for the use of idarucizumab to reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate mesylate). 2 March 2015
Biotechnology
US biotech firm Amarin has entered into an exclusive agreement for Chinese drugmaker Eddingpharm to develop and commercialize Vascepa (icosapent ethyl). 28 February 2015
Generics
University of Manchester researchers, together with industrial partner, Dutch biotech company DSM, have developed a single-step fermentative method for the production of leading cholesterol-lowering drug, pravastatin, the active ingredient of Bristol-Myers Squibb's now off patent Pravachol, which will facilitate industrial-scale statin drug production. 27 February 2015
Pharmaceutical
The global market for atrial fibrillation treatment will more than double in value between 2013 and 2020, says research and consulting firm GlobalData. 26 February 2015
Pharmaceutical
US drug major Eli Lilly has accepted the recommendation of the ACCELERATE study academic executive committee to extend its Phase III trial of evacetrapib by six months. 20 February 2015
Generics
Israeli generic giant Teva Pharmaceutical Industries has launched a generic equivalent of French pharma major Sanofi’s Lovenox (enoxaparin sodium injection) in seven dosage strengths in the USA. 17 February 2015
Pharmaceutical
The US Food and Drug Administration has granted priority review designation for combination pill LCZ696 (valsartan and sacubitril), an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF), from Swiss pharma giant Novartis. 14 February 2015
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has agreed to pay the US government $7.9 million to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced yesterday. 12 February 2015
Biotechnology
UK biotech company Cell Therapy has raised over £691,000 ($1 million) through crowdfunding on Crowdcube to fund its stem cell medicine Heartcel which regenerates heart muscle to treat heart failure. 9 February 2015
Pharmaceutical
Privately-held US drugmaker Symplmed Pharmaceuticals says that the US Food and Drug Administration has approved Prestalia (perindopril arginine and amlodipine) tablets for the treatment of hypertension. 27 January 2015
Biotechnology
The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for Praluent (alirocumab), which is under development by French pharma major Sanofi and US partner Regeneron Pharmaceuticals. 26 January 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the health costs watchdog for England, today issued its final appraisal determination (FAD) for German pharma major Bayer’s already blockbuster oral Factor Xa inhibitor Xarelto (rivaroxaban) in a new indication. 23 January 2015
Pharmaceutical
German drug major Bayer has updated the label for its Xarelto (rivaroxaban) in Europe. 20 January 2015
Pharmaceutical
Tianyin Pharmaceutical says TPI and Buchang Pharmaceutical plan to establish Tianyin-Buchang Strategic Alliance synergize and accelerate the growth of the company, boosting TPI's mTCM franchise focusing on its cardiovascular revenue driver Gingko Mihuan (GMOL). 15 January 2015
Biotechnology
US biotech firm Aegerion Pharmaceuticals has revealed it is the subject of a US Securities and Exchange Commission investigation relating to its sales activities. 14 January 2015
Pharmaceutical
Anglo-Swedish drug major AstraZeneca has announced its PEGASUS-TIMI 54 study of Brilinta (ticagrelor) has met its primary endpoint. 14 January 2015
Pharmaceutical
More than one in 10 US adults are receiving inappropriate aspirin therapy for the primary prevention of cardiovascular disease, according to research published in the Journal of the American College of Cardiology. 14 January 2015
Pharmaceutical
The therapeutics market is buzzing with activity, as several promising therapies are progressing to Phase III clinical trials and many more are awaiting commercial launches. 13 January 2015
Pharmaceutical
Russia's Nanolek has officially commissioned a new facility for the production of drugs for the treatment of cardiovascular, cancer and infectious diseases. 12 January 2015
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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