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Pharmaceutical
Japanese drug major Daiichi Sankyo (TYO: 4568) has released encouraging results from the global Phase III Hokusai-VTE study of edoxaban (trade name Lixiana) in 8,292 patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or both, suggesting it could compete with rivals such as Bayer, Boehringer Ingelheim, Johnson & Johnson, Bristol-Myers and Pfizer in the venous thromboembolism market, which has been forecast as reaching a value of more than $10 billion. 2 September 2013
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) and US partner Bristol-Myers Squibb (NYSE: MBY) today (September 2) announced positive full results of the SAVOR clinical trial in 16,492 adult patients with type 2 diabetes at high risk for cardiovascular events. 2 September 2013
Pharmaceutical
German drug major Bayer (BAYN: DE) and Johnson & Johnson (NYSE: JNJ) subsidiary Janssen's Xarelto (rivaroxaban) will be the sales-leading therapy among the novel oral anticoagulants in the combined venous thromboembolism (VTE) markets, according to a new report from health care advisory firm Decision Resources. 30 August 2013
Pharmaceutical
The US Food and Drug Administration has accepted for review German independent drug major Boehringer Ingelheim's supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for its use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE). 28 August 2013
Pharmaceutical
The US Food and Drug Administration should warn patients and doctors that taking the widely prescribed drug Plavix (clopidogrel), the now off-patent blockbuster anti-platelet agent from French drug major Sanofi (Euronext: SAN), for more than a year after having a drug-eluting stent implanted can lead to major bleeding, which can kill, US consumer health advocacy Public Citizen said in a petition to the agency. 21 August 2013
Pharmaceutical
The radiopharmaceuticals market has been forecast to exceed a value of $7.9 billion by 2018, driven by the aging global population, the increasing number of cardiovascular, oncological and neurological imaging procedures, and the expansion in application areas, according to a new report added to the offering of Companiesandmarkets.com. 21 August 2013
Biotechnology
USA-based Amgen (Nasdaq: AMGN), the world's leading independent biotech firm, and privately-held French drugmaker Laboratoires Servier have announced the early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in connection with the cardiovascular product collaboration agreement announced last month (The Pharma Letter July 10, 2013, completing the transaction. 13 August 2013
Pharmaceutical
Leading Russian drugmaker Akrikhin says it has expanded its partnership with US pharma giant Merck & Co (NYSE: MRK) within the scope of Merck's product manufacturing localization strategy in Russia. 8 August 2013
Pharmaceutical
Long-term use of a calcium-channel blocker to treat hypertension (high blood pressure) is associated with higher breast cancer risk, according to a study published by JAMA Internal Medicine, a Journal of the American Medical Association Network publication and reported by EurekAlert. 6 August 2013
Pharmaceutical
A new survey commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA) shows 86% of Americans believe developing cures for more forms of cancer should be one of the top national health priorities, followed by developing effective treatments for heart disease (78%) and more intensive medical care for seniors (76%). 5 August 2013
Biotechnology
The European Commission has approved US biopharma company Aegerion Pharmaceuticals' (Nasdaq: AEGR) Lojuxta (lomitapide) hard capsules as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious medical condition. 5 August 2013
Pharmaceutical
The reduction in mortality as a result of cardiovascular disease is due to a combination of healthier lifestyles and effective medicine, notes the Danish Pharmaceutical industry association LIF. 30 July 2013
Biotechnology
US biotech firm Chelsea Therapeutics (Nasdaq: CHTP) has received acknowledgment of its resubmitted New Drug Application to the US Food and Drug Administration (FDA) to market Northera (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). 29 July 2013
Pharmaceutical
US pharma giant Merck & Co (NYSE: MRK) has said the New Drug Application (NDA) for its once-troubled investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the US Food and Drug Administration. 25 July 2013
Generics
US drugmaker Forest Laboratories (NYSE:FRX) and Forest Laboratories Holdings have reached a settlement agreement with USA-based Amerigen Pharmaceuticals over a patent infringement litigation. 22 July 2013
Generics
Impax Laboratories (Nasdaq: IPXL) today announced yesterday (July 15) that it is commencing shipment of authorized generic Trilipix (fenofibric acid) delayed release capsules, 45mg and 135 mg, through its generics division Global Pharmaceuticals. 16 July 2013
Pharmaceutical
Swiss drug major Novartis (NOVN: VX) has admitted that there was an undisclosed conflict of interest in a study of one of its drugs carried out at a Japanese university, but says guidelines now in place are followed by all its employees, reports swissinfo.ch, the international service of the Swiss Broadcasting Corporation. 15 July 2013
Pharmaceutical
Japanese drug major Daiichi Sankyo (TYO: 4568) presented positive results of the PRASFIT-Elective Phase III study for its antiplatelet agent prasugrel hydrochloride in patients with coronary artery disease at the 22nd Annual Meeting of the Japanese Association of Cardiovascular Intervention and Therapeutics. 14 July 2013
Pharmaceutical
US pharma major Bristol-Myers Squibb (NYSE: BMY) and behemoth Pfizer (NYSE: PFE) announced that the US Food and Drug Administration has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis (apixaban), for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 15, 2014, the companies noted. 12 July 2013
Biotechnology
Norwegian biopharma company Serodus (Oslo Axess: SER) says that, following approval by an extraordinary general meeting (EGM), it is to merge with Danish peptide specialist Phlogo ApS. Serodus will acquire the Danish firm for 1.30 Norwegian kroner per share, for a total of some 2.6 million kroner ($424, 290), according to a web site notice. 12 July 2013
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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