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Biotechnology
French drug major Sanofi and US biotech company Regeneron have announced that the European Medicines Agency has accepted their Marketing Authorization Application for Praluent (alirocumab) for review. 12 January 2015
Biotechnology
French pharma major Sanofi and Regeneron Pharmaceuticals today announced that two new ODYSSEY trials, which are the first Phase III trials to assess alirocumab administered every four weeks, met their primary efficacy endpoints. 9 January 2015
Pharmaceutical
The US Food and Drug Administration late yesterday approved Japanese drug major Daiichi Sankyo’s anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. 9 January 2015
Pharmaceutical
The US Food and Drug Administration has approved the New Drug Application for Namzaric (formerly known as MDX-8704), a fixed-dose combination (FDC) of memantine extended-release, a NMDA receptor antagonist, and donepezil, an acetylcholinesterase inhibitor, from Ireland-headquartered generics major Actavis and partner Adamas Pharmaceuticals. 26 December 2014
Pharmaceutical
Swiss biotech company Actelion has submitted a New Drug Application to the US Food and Drug Administration seeking approval for its pulmonary arterial hypertension drug Uptravi (selexipag). 23 December 2014
Pharmaceutical
Canadian drugmaker Cardiome Pharma has entered into an agreement with Chinese firm Eddingpharm to develop and commercialize Brinavess (vernakalant intravenous) in China, Taiwan, and Macau and re-launch the drug in Hong Kong. 22 December 2014
Pharmaceutical
Seven new drugs have been recommended for marketing authorization at the December 2014 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This brings the total number of medicines recommended for approval by the CHMP in 2014 to 82. 19 December 2014
Pharmaceutical
US drugmaker The Medicines Company and SciClone Pharmaceuticals, a USA-based, China focused specialty pharmaceutical company, have established a strategic partnership for two cardiovascular products in China. 19 December 2014
Pharmaceutical
US pharma company Pozen has received a second complete response letter from the US Food and Drug Administration for Yosprala (aspirin/omeprazole delayed release tablets). 18 December 2014
Biotechnology
Privately-held biotech firm X-Chem has licensed a second drug discovery program to German pharma major Bayer under the multi-target collaboration the companies established in July 2012. 18 December 2014
Pharmaceutical
Following evaluation of disappointing clinical results, Danish CNS specialists Lundbeck said late yesterday that it has decided to cease further development of desmoteplase in ischemic stroke. Alternatives including divestiture are now being evaluated. 18 December 2014
Pharmaceutical
A Phase III clinical trial has found that Portola Pharmaceuticals' andexanet alfa reverses the effects of the anticoagulant apixaban, with the news leading to a 4.1% rise to $28.50 in the company’s share price. 17 December 2014
Pharmaceutical
In final guidance published today, UK health cost watchdog the National Institute for Health and Care Excellence (NICE) has recommended German family-owned pharma major Boehringer Ingelheim’s anti-blood clotting drug Pradaxa (dabigatran) for additional uses. 17 December 2014
Generics
Japanese pharma major Daiichi Sankyo says its generics subsidiary, Daiichi Sankyo Espha, has launched nine new generic drugs with three new active ingredients. 15 December 2014
Pharmaceutical
The Scottish Medicines Consortium has decided to grant access to Gazyvaro (obinutuzumab), manufactured by Swiss drug major Roche for the treatment of chronic lymphocytic leukemia. 8 December 2014
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined a dossier on Eliquis (apixaban), coming up with mixed conclusions. 5 December 2014
Pharmaceutical
Swiss biotech firm Actelion has submitted a centralized Marketing Authorization Application to the European Medicines Agency for selexipag (trade name Uptravi) in the treatment of pulmonary arterial hypertension (PAH). 3 December 2014
Pharmaceutical
Swiss drug major Novartis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to LCZ696, an investigational medicine for patients with heart failure with reduced ejection fraction (HFrEF). 28 November 2014
Generics
US generic drugmaker Mylan today confirmed that it and several subsidiaries have been sued by US drugmaker Baxter International and two of its affiliates in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for esmolol HCl in sodium chloride injection. 25 November 2014
Pharmaceutical
The European Medicines Agency has reviewed angina medication Corlentor/Procoralan (ivibradine), manufactured by French privately-held drugmaker Servier, in a bid to reduce heart problems including heart attack and bradycardia, in patients taking the drug. 21 November 2014
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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