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Biotechnology
South Korean drugmaker Celltrion has signed an ‘incubation’ agreement with Emory University in Atlanta, USA, to support the research and development of new drug candidates for atherosclerosis. 20 September 2018
Pharmaceutical
A large clinical study, funded by the US National Institutes of Health and published in the New England Journal of Medicine, shows that older people taking daily low-dose aspirin as a prophylactic did not lower their risks of cardiovascular disease, dementia or disability. 18 September 2018
Biotechnology
The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) for Praluent (alirocumab) Injection, a PCSK9 inhibitor. 12 September 2018
Generics
India’s Sun Pharmaceutical Industries has received six adverse observations after a US Food and Drug Administration inspection found one of its plants to be lacking in certain processes. 10 September 2018
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC has announced a major funding package involving ten medicines in seven key therapy areas through an agreement with Swiss pharma giant Novartis. 6 September 2018
Pharmaceutical
For the second quarter in a row, German life sciences company Bayer has lowered its earnings guidance for the full year in presenting its financial results. 5 September 2018
Biotechnology
Shares in Californian biopharma MannKind Corporation closed 89% up on Tuesday as markets reacted to its licensing deal with biotech company United Therapeutics Corporation. 5 September 2018
Biotechnology
Though being vague on terms, and not naming the collaboration partner for a new licensing deal, UK life sciences firm OptiBiotix Health saw its shares, which had already risen 72% in the year to date, gain a further 6.5% to 105.97 pence by early afternoon trading today. 4 September 2018
Pharmaceutical
Last week’s news attracting attention included European approvals for two CAR-T therapies, Novartis’ Kymriah and Gilead Sciences’ Yescarta, as well as AstraZeneca gaining clearance for its Lynparza in China, making it the first ovarian cancer drug to be approved under China’s accelerated system. On the research front, there was the release of new Phase III data on Pfizer’s rare heart disease drug Vyndaqel (tafamidis). Among deal-making news was that between Affimed with Roche on immunotherapies, worth a potential $5 billion, and Emergent BioSolutions announcing a second acquisition, Adapt Pharma, adding to its buy of PaxVax. 2 September 2018
Pharmaceutical
As part of its stated aim to understand more clearly the underlying links between the heart, kidney and pancreas, Anglo-Swedish pharma major AstraZeneca has announced two advances of its heart failure (HF) research program for Forxiga (dapagliflozin), an approved type-2 diabetes drug. 29 August 2018
Biotechnology
Pfizer announced on Tuesday that its Phase III studies of Vyndaqel (tafamidis) show the drug significantly reduced mortality and cardiovascular-related hospitalizations compared to placebo over a 30-month period in patients with wild type or variant transthyretin amyloid cardiomyopathy. 28 August 2018
Pharmaceutical
It is not unexpected to see mainstream media giving coverage to data showing potential in a drug that could be a big player in the fight against obesity in middle-aged people. 28 August 2018
Pharmaceutical
Although they showed some merits, overall there was disappointment with trial results from the Phase III MARINER and COMMANDER HF (heart failure) studies, which were presented this week at the European Society of Cardiology (ESC) Congress 2018 and simultaneously published in The New England Journal of Medicine. 28 August 2018
Pharmaceutical
There was good news today for Swiss pharma giant Novartis, with new data showing that its heart failure drug. sales of which have so far failed to meet expectations, was safe and effective in patients stabilized after hospitalization for acute HF regardless of whether they received it in-hospital or after discharge. 25 August 2018
Biotechnology
California, USA-based biotech Global Blood Therapeutics yesterday revealed that is picking up rights to a cardiovascular drug candidate for a mere $2 million upfront, but still saw its share fall 3.33% to $49.40. 24 August 2018
Pharmaceutical
German life sciences group Bayer had a welcome opportunity on Friday to talk about some news that did not involve potential problems with its takeover of the US agro-chemicals company Monsanto. 24 August 2018
Generics
The Chinese company Zhejiang Tianyu is no longer authorized to manufacture the valsartan active substance for European Union medicines following the suspension of its CEP – a certificate verifying that the quality of its valsartan meets European requirements, the European Medicines Agency announced today (August 20). 20 August 2018
Pharmaceutical
The slow rate of its country’s adoption of innovative medicines has long been a bone of contention for the Irish Pharmaceutical Healthcare Association (IPHA), the representative body for the international research-based pharmaceutical industry in Ireland. 13 August 2018
Pharmaceutical
Aralez Pharmaceuticals has announced it will enter into purchase agreements with two so-called ‘stalking-horse purchasers’ to sell its main business. 10 August 2018
Pharmaceutical
Indian drug major Sun Pharmaceutical Industries has launched Kapspargo Sprinkle (metoprolol succinate) extended-release capsules in the USA. 7 August 2018
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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