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Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) said yesterday (June 18) that it has received an offer for its thrombosis brands and Notre-Dame de Bondeville (NDB) site from Aspen Global and Aspen Pharmacare (JSE: APN), South Africa's largest drugmaker. A period of exclusivity has been agreed with Aspen and GSK will respond to the offer subject to consultation with employees and the relevant works councils. 19 June 2013
Pharmaceutical
Japanese drug major Daiichi Sankyo (TYO: 4568) says that it has submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan for the antiplatelet agent prasugrel for the treatment of patients with ischemic heart disease undergoing percutaneous coronary intervention (PCI). Analysts at Credit Suisse have a net present value for prasugrel of 78.19 yen per share (4% of total) for Daiichi Sankyo. 18 June 2013
Biotechnology
US drugmaker Santarus (Nasdaq: SNTS) and Netherlands-based Pharming Group (NYSE Euronext: PHARM) say that the US Food and Drug Administration has accepted for filing the Biologics License Application for the investigational drug Ruconest (recombinant human C1 esterase inhibitor) 50IU/kg. Ruconest is approved in Europe for the treatment of acute angioedema attacks in patients with HAE. 18 June 2013
Pharmaceutical
In India, some key cancer drugs, antibiotics and medicines to treat cardiovascular diseases and tuberculosis are set to become cheaper by up to 50% within the next 45 days. The National Pharmaceutical Pricing Authority (NPPA) will shortly notify prices of as many as 150 packs of essential medicines in line with the new pharma pricing policy, according to official sources quoted by the Indian newspaper the Business Standard. 17 June 2013
Pharmaceutical
America's biopharmaceutical research companies are developing 215 medicines for two of the leading causes of death of Americans - heart disease and stroke, according to a new report and overview released yesterday (June 12) by the Pharmaceutical Research and Manufacturers of America (PhRMA). 13 June 2013
Biotechnology
USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech company, has expanded its strategic collaboration with Cytokinetics (Nasdaq: CYTK) to include Japan. In 2006, Cytokinetics and Amgen entered into a collaboration to discover, develop and commercialize novel small-molecule therapeutics that activate cardiac muscle contractility for potential applications in the treatment of heart failure. 12 June 2013
Pharmaceutical
UK-based Abcam (AIM: ABC), a producer and distributor of protein research tools, has entered into a license agreement with global pharma behemoth Pfizer (NYSE: PFE). Under the terms of the agreement, Abcam's Biochemicals division will supply a range of authentic Pfizer compounds for use as preclinical research tools by researchers worldwide, alongside the Abcam Biochemicals range of over 2000 bioactive small molecules. 12 June 2013
Pharmaceutical
New Zealand's Pharmaceutical Management Agency, PHARMAC, says it has reached an agreement with the local subsidiary of Anglo-Swedish drug major AstraZeneca (LSE: AZN) to fund the company's antiplatelet agent ticagrelor (Brilinta). 10 June 2013
Biotechnology
There was disappointing news from French drug major Sanofi (Euronext: SAN) this morning (June 3), as the company revealed negative top-line results from the Phase III ECLIPSE trial of iniparib in squamous non-small cell lung cancer (Sq NSCLC). 3 June 2013
Biotechnology
Emerging Israeli biopharma company RedHill Biopharma (TASE: RDHL) says that it recently concluded a positive Type B meeting with the US Food and Drug Administration regarding its cardio drug RHB-101, a controlled release, proprietary, once-daily formulation of carvedilol, for the treatment of congestive heart failure and hypertension. 29 May 2013
Biotechnology
World leading independent biotech firm Amgen (Nasdaq: AMGN) has joined forces with Japanese drug major Astellas Pharma (TYO: 4503) in a strategic alliance to provide new medicines to help address serious unmet medical needs of Japanese patients. No financial terms of the accord were revealed. 29 May 2013
Pharmaceutical
Anglo-Swedish drug major AstraZeneca's (LSE: AZN) new chief executive Pascal Soriot is making another "strategic" acquisition, this morning (May 28) revealing that the company has entered into a definitive agreement to purchase Omthera Pharmaceuticals, a specialty drug company based in Princeton, New Jersey, focused on the development and commercialization of new therapies for abnormal levels of lipids in the blood, or dyslipidemia. The deal has been approved by the boards of both companies. 28 May 2013
Pharmaceutical
German chemical and pharma group Bayer (BAYN: DE) says that its novel oral anticoagulant Xarelto (rivaroxaban) has been approved by the European Commission for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an acute coronary syndrome (ACS) in adult patients with elevated cardiac biomarkers at a dose of 2.5mg twice-daily (BID) in combination with standard antiplatelet therapy. 28 May 2013
Pharmaceutical
USA and China-based Zensun Science & Technology has revealed positive results of four completed Phase II clinical trials including three double-blind, placebo-controlled studies conducted in China and Australia and interim results from the US Phase II trial for Zensun's innovative "first-in-class" anti-heart failure drug, Neucardin, which has just been licensed to the USA's SciClone Pharmaceuticals (Nasdaq: SCLN) for Greater China (The Pharma Letter May 20). 23 May 2013
Pharmaceutical
Results from a large observational study reported at EuroPCR 2013 (the official annual meeting of the European Association for Percutaneous Cardiovascular Interventions; EAPCI) this week question whether bivalirudin - The Medicines Company's (Nasdaq: MDCO) Angiomax - is superior to heparin in the absence of GPIIb/IIIa blockade, showing similar 30-day mortality in patients with non-ST segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI). 22 May 2013
Pharmaceutical
USA-based SciClone Pharmaceuticals (Nasdaq: SCLN) today announced that the Company has entered into an agreement with Zensun (Shanghai) Science & Technology granting SciClone a license and the exclusive rights in China, Hong Kong and Macau to promote, market, distribute and sell Neucardin, a genetically engineered recombinant peptide fragment of neuregulin-1 and a novel, first-in-class therapeutic drug for the treatment of patients with intermediate to advanced chronic heart failure (CHF). 20 May 2013
Generics
US drugmaker Impax Laboratories (Nasdaq: IPXL) says that its generics division, Global Pharmaceuticals, commenced shipment of an authorized generic version of Zomig (zolmitriptan) tablets and orally disintegrating tablets, 2.5mg and 5mg, in the USA, as part of a distribution, license, development and supply agreement with Anglo-Swedish drug major AstraZeneca (LSE: AZN). 20 May 2013
Pharmaceutical
Leading Belgian drugmaker UCB (Euronext Brussels: UCB) today (May 17) announced data from a double-blind, placebo-controlled study that found that Neupro (rotigotine transdermal system) reduced total nocturnal systolic blood pressure (NSBP) elevations associated with periodic limb movements during sleep (PLMS) and total PLMS in patients with idiopathic moderate-to-severe Restless Legs Syndrome (RLS)/Willis-Ekbom disease. The data were presented at the Annual Scientific Meeting of the American Society of Hypertension, May 15-18, 2013. 17 May 2013
Pharmaceutical
US GPCR ligand drug developer Trevena and Forest Laboratories (NYSE: FRX) have entered into a collaborative licensing option agreement for the development of TRV027, an AT1R biased-ligand that recently completed Phase IIa clinical trials. Trevena expects to commence a 500-patient multicenter Phase IIb clinical trial in acute decompensated heart failure (ADHF) by year end. 10 May 2013
Pharmaceutical
US drug major Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE) reported results from a pre-specified sub-analysis of the ARISTOTLE trial (n=18,201) showing that the reduction in stroke or systemic embolism, number of major bleeding events and mortality demonstrated with Eliquis (apixaban) compared to warfarin were consistent across subgroups defined based on levels of International Normalized Ratio control in patients with non-valvular atrial fibrillation. 7 May 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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