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Biotechnology
The US Food and Drug Administration yesterday announced two more drug candidates have been granted coveted Breakthrough Therapy designations (BTD). 24 May 2018
Pharmaceutical
Positive trial results don’t appear to have boosted Esperion Therapeutics in the way the Michigan, USA-based lipid specialist might have hoped. 24 May 2018
Biotechnology
The European Commission (EC) has approved a new indication in the Repatha (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels. 17 May 2018
Pharmaceutical
News in the past week featured two exciting sets of research results, with Allergan reporting positive Phase III trial results for its migraine drug candidate ubrogepant and mid-stage reports on Karyopharm’s selinexor in multiple myeloma. On the regulatory front, Novartis gained an additional approval from the US Food and Drug Administration for Kymriah in lymphoma, but this has raised questions. There was also a nice surprise for Portola Pharmaceuticals, with long-awaited approval for its anticoagulant reversal agent AndexXa. Also attracting comment was the decision of Ironwood Pharmaceuticals to split into two separate businesses. 6 May 2018
Biotechnology
US biotech firm Regeneron Pharmaceuticals today reported first-quarter 2018 financials, showing mixed results, with total revenues of $1.51 billion (up 15%) missing consensus by 1% and Leerink estimates by 5%. 3 May 2018
Pharmaceutical
German life sciences group Bayer has laid the blame for a drop in earnings on the euro’s strength against other currencies in presenting its financial results for the first quarter of 2018. 3 May 2018
Pharmaceutical
After two week of trial and two days of deliberation, a Philadelphia jury has up a defense verdict in favor of Germany’s Bayer and Johnson & Johnson subsidiary Janssen Pharmaceuticals, finding that the label on the blood thinner Xarelto (rivaroxaban) adequately warned patients about the danger of severe bleeds, reported the publication Legal Intelligence. 30 April 2018
Biotechnology
Omeicos Opthalmics, a subsidiary of German biotech Omeicos Therapeutics, has named Alexander Gebauer as its first chief executive. 27 April 2018
Biotechnology
Californian biotech Amgen has reported an increase of 2% in revenues for the first quarter of 2018, up to $5.6 billion, beating analysts expectations. 25 April 2018
Pharmaceutical
Family-owned German pharma Boehringer Ingelheim today presented its latest pipeline updates at a R&D press conference titled ‘Transcending Disease Boundaries’, at its global headquarters in Ingelheim. 25 April 2018
Pharmaceutical
A huge reduction in opioid prescriptions is the most striking feature of the latest report from the IQVIA Institute for Human Data Science on medicine usage and spending in the USA. 19 April 2018
Pharmaceutical
US healthcare giant Johnson & Johnson’s Janssen unit has entered a new worldwide collaboration with Bristol-Myers Squibb on a program to develop and commercialize Factor XIa (FXIa) inhibitors, including BMS-986177, for the prevention and treatment of major thrombotic conditions. 17 April 2018
Biotechnology
Bristol-Myers Squibb and the Harvard Fibrosis Network of the Harvard Stem Cell Institute have entered into a research collaboration to discover and develop potential new therapies for fibrotic diseases. 13 April 2018
Biotechnology
Insurers denied coverage for nearly 80,000 patient claims for cholesterol-lowering drugs known as PCSK9 inhibitors in 2017, according to new findings. 12 April 2018
Pharmaceutical
Some eight years after the drug won its first approval in Europe, Anglo Swedish pharma major AstraZeneca is still building the case for Brilinta (ticagrelor) in cardiovascular (CV) disease and associated complications. 10 April 2018
Pharmaceutical
Daiichi Sankyo has reached an agreement to modify certain aspects of the settlement program, which was entered into and announced on August 1, 2017, on behalf of all defendants, resolving pending product liability litigation related to olmesartan products. 3 April 2018
Pharmaceutical
The tafamidis Phase III Transthyretin Cardiomyopathy (ATTR-ACT) study evaluating tafamidis for the treatment of transthyretin cardiomyopathy has met its primary endpoint, demonstrating a statistically-significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo at 30 months. 30 March 2018
Pharmaceutical
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting. 24 March 2018
Pharmaceutical
Pradaxa (dabigatran etexilate) has had its safety profile strengthened by new data from one of the largest real-world studies of its kind. 21 March 2018
Pharmaceutical
The authorities of the Russian capital Moscow plan to sign a contract on the establishment of a large-scale pharmaceutical production plant within the city with the aim of their further supplies for the needs of the region. 20 March 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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