Cardio-vascular
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Pharmaceutical
Johnson & Johnson has announced new results from a real-world meta-analysis of therapies, including Xarelto (rivaroxaban), for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). 12 March 2019
Pharmaceutical
Adhera Therapeutics and Alyvant, yesterday announced a digital co-promotion agreement for Prestalia (perindopril arginine and amlodipine) therapy for the treatment of hypertension. 5 March 2019
Generics
Even as more blood pressure drugs are being recalled in the USA after being found to contain trace amounts of a potentially cancer-causing ingredient, India’s drug controller is putting stringent quality control measures in place aiming to boost public confidence in generic medicines, reports The Pharma Letter’s India correspondent. 5 March 2019
Generics
The US Food and Drug Administration determined that there is no clinical need to compound vasopressin under Section 503B of the Drug Quality and Security Act. 4 March 2019
Pharmaceutical
Aspirin may be over 100 years old, but OtiTopic believes the potential of the analgesic workhorse to provide innovative therapies is yet to be exhausted. 1 March 2019
Pharmaceutical
Private investment platform Blackstone Life Sciences and Novartis have launched Anthos Therapeutics, a biopharma focused on cardiovascular (CV) disease. 28 February 2019
Pharmaceutical
Shares in German life sciences company Bayer were up by 4% after four hours of trading on Wednesday, when the firm’s financial results for the fourth quarter and 2018 as a whole were announced. 27 February 2019
Pharmaceutical
On Monday, another chapter in the years-long legal saga between Amgen and Sanofi was written by a District Court jury, which upheld certain patents for Amgen’s Repatha (evolocumab). 26 February 2019
Biotechnology
Novartis is far from finished trying to maximize the life cycle of its blockbuster heart failure drug Entresto (sacubitril/valsartan), but that is by no means its only target in the cardiovascular (CV) space, a new deal shows. 25 February 2019
Pharmaceutical
London-listed AstraZeneca has announced positive results from the Phase III THEMIS trial, which met its primary endpoint. 25 February 2019
Pharmaceutical
Drugmaker Cipla is to acquire an 11.7% stake in digital therapeutics company Wellthy Therapeutics. 19 February 2019
Biotechnology
Last week, USA-based Regeneron Pharmaceuticals and French pharma major Sanofi were the latest to announce a massive price reduction for their PCSK9 inhibitor. 18 February 2019
Pharmaceutical
Among the most interesting news last week on pricing, Regeneron and Sanofi slashed the cost of their PCSK9 inhibitor cholesterol lowerer Praluent in the USA. Research news included disappointing Phase III results for Gilead Sciences with its NASH candidate selonsertib. There was bad news for GlaxoSmithKline when Mylan finally launched Wixela Inhub, a generic copy of its top-selling asthma drug Advair Diskus in the all important US market. And on the deal-making front, Belgium’s UCB partnered with the Epilepsy Society to better understand diagnosis and treatment of the disease. 17 February 2019
Pharmaceutical
Results from the CAROLINA (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) met its primary endpoint, defined as non-inferiority for Tradjenta (linagliptin) versus glimepiride (Sanofi’s Amaryl) in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE). 15 February 2019
Biotechnology
Roche and Boehringer Ingelheim’s Activase (alteplase) is currently the only treatment of acute ischemic stroke (AIS), but this situation will start to change from 2021, according to GlobalData. 13 February 2019
Biotechnology
Joining in what looks set to be a price war for biotech drugs called PCSK9 inhibitors for the treatment of bad cholesterol, USA-based Regeneron Pharmaceuticals and partner French pharma major Sanofi today announced a further reductions of their partnered product. 11 February 2019
Generics
Ireland-incorporated drugmaker Endo International has announced that the US Food and Drug Administration (FDA) has requested a further stay of Endo's ongoing litigation against the FDA through March 15. 7 February 2019
Biotechnology
US biotech Regeneron Pharmaceuticals today released financial results, showing that fourth quarter 2018 revenues were $1.93 billion, an increase of 22%. Full-year revenues were $6,711 billion, up 14%. 6 February 2019
Pharmaceutical
United Therapeutics has presented key data from the FREEDOM-EV study of Orenitram (treprostinil) extended-release tablets at the annual congress of the Pulmonary Vascular Research Institute in Barcelona. 1 February 2019
Pharmaceutical
French privately-held drugmaker Servier today announced that group’s sales for the 2017-2018 financial year were 4.2 billion euros ($4.8 billion), a year-on-year rise of 4.5%. 31 January 2019
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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