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Biotechnology
Janssen Biotech, a unit of US healthcare giant Johnson & Johnson has decided not to exercise its option to exclusively license on CAP-1002 (allogeneic cardiosphere-derived cells) for development and commercialization in the field of cardiology. 7 July 2017
Pharmaceutical
The heart failure space across the seven key markets of the USA, France, Germany, Italy, Spain, the UK and Japan is set to grow from $3.7 billion in 2016 to around $16.1 billion by 2026, representing an impressive compound annual growth rate of 15.7%. 3 July 2017
Biotechnology
Attracting a great deal of comment last week, was Merck & Co’s positive clinical trial results with anacetrapib, a compound in the CEPT inhibitor class that has seen a number of notable failures. Also hitting the headlines was Seattle Genetics and Takeda’s Adcetris, mixed news on Alder Pharmaceuticals’ eptinezumab, Portola’s approval of BevyxXa, and Roche’s new hemophilia A drug emicizumab. 2 July 2017
Biotechnology
Eiger BioPharmaceuticals has signed an agreement to sell a non-strategic asset, Mydicar (rAAV1-SERCA2a), to privately-held biotech firm Theragene Pharmaceuticals. 29 June 2017
Biotechnology
In a surprising turn of events for its cholesteryl ester transfer protein (CETP) drug candidate anacetrapib, US pharma giant Merck & Co posted encouraging Phase III results for the drug. 28 June 2017
Biotechnology
With its shares up 5% at 83.85 Swiss francs by late afternoon, Novartis led gainers on the SIX Exchange, after the pharma giant said its canakinumab helped reduce the risk of cardiovascular events in patients who had previously suffered a heart attack. 22 June 2017
Pharmaceutical
The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has completed its meeting regarding the supplemental New Drug Application (sNDA) for inclusion of the data from the cardiovascular outcomes trial LEADER in the label for Victoza (liraglutide). 21 June 2017
Pharmaceutical
A US Food and Drug Administration (FDA) advisory committee will next week discuss whether Victoza, the Novo Nordisk type 2 diabetes drug can have cardiovascular safety added to its label. 16 June 2017
Biotechnology
Following release of new clinical evidence in March 2017, the US Institute for Clinical and Economic Review (ICER) has developed a New Evidence Update to its 2015 review of the comparative clinical effectiveness and value of PCSK9 inhibitors for management of high cholesterol. The comparative clinical effectiveness portion of the update is now available. 14 June 2017
Pharmaceutical
Findings from a post-hoc analysis of the LEADER cardiovascular (CV) outcomes trial showed that the Novo Nordisk treatment Victoza (liraglutide) resulted in similar reductions in the chance of major CV events in people with type 2 diabetes at high CV risk, regardless of whether they experienced an episode of severe hypoglycemia during the study. 12 June 2017
Biotechnology
French pharma major Sanofi and USA-based Regeneron Pharmaceuticals have announced that two Phase IIIb/IV trials of Praluent successfully met their primary endpoints. 12 June 2017
Pharmaceutical
The US subsidiary of Canada’s Aralez Pharmaceuticals today announced that the national commercial launch of Zontivity (vorapaxar) in the USA will commence this week. 7 June 2017
Pharmaceutical
The venous thromboembolism (VTE) space across the seven major markets of the USA, France, Germany, Italy, Spain, the UK and Japan, is set to rise from $1.95 billion in 2016 to around $2.85 billion by 2026, representing a strong compound annual growth rate (CAGR) of 3.87%. 7 June 2017
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC today announced the approval of an agreement for the supply of metoprolol succinate long-acting tablets. 6 June 2017
Biotechnology
Amgen today announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and a variation to the marketing authorization to the European Medicines Agency for Repatha (evolocumab), a PCSK9 inhibitor. 5 June 2017
Pharmaceutical
A new study has found that published cost-effectiveness claims related to cardiovascular therapies tend to assume a mortality benefit, without clear support from gold standard clinical trial data. 2 June 2017
Generics
Indian drugmaker Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic nebivolol product. 30 May 2017
Biotechnology
German drugmaker Boehringer Ingelheim has presented new analyses on the use of Ofev (nintedanib) in treating idiopathic pulmonary fibrosis (IPF), supporting existing safety and efficacy data. 24 May 2017
Pharmaceutical
Italian drugmaker Recordati has agreed to acquire the rights to Seloken/Seloken ZOK (metoprolol succinate) and associated Logimax fixed dose combination (metoprolol succinate and felodipine) treatments in Europe from Anglo-Swedish pharma major AstraZeneca. 22 May 2017
Biotechnology
Californian biotech firm La Jolla Pharmaceutical has published in The New England Journal of Medicine data from a Phase III results into LJPC-501 (angiotensin II) as a treatment for the heart condition vasodilatory shock. 22 May 2017
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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