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Pharmaceutical
US drug majors Pfizer and Bristol-Myers Squibb saw their share prices rise on Friday after announcing that they have agreed to stop the Phase III AVERROES clinical trial of apixaban in patients with atrial fibrillation. 14 June 2010
Generics
India largest drugmaker, Ranbaxy Laboratories (which is majority owned by Japan's Daiichi Sankyo) announced this morning that it has launched a generic version of the antiplatelet drug prasugrel in India under the trade name Prasita. 10 June 2010
Pharmaceutical
French drug major Sanofi-Aventis said this week that it has signed a cooperation agreement for R&D on innovative medicines and therapies with the Charite Universitatsmedizin Berlin, Germany, just days after entering a research accord with the USA's Massachusetts Institute of Technology Center for Biomedical Innovation (The Pharma Letter May 27). Financial deals of the deal were not disclosed. 2 June 2010
Pharmaceutical
US global drugs behemoth Pfizer says that it plans to halt recruitment to the EMPHASIS-HF trial, assessing Inspra (eplerenone), early on the recommendations of the trial's independent Executive Steering Committee (ESC). This follow a second interim analysis by the independent Data Safety Monitoring Committee (DSMC) of the study confirming that it has reached its primary efficacy endpoint early according to the protocol pre-defined stopping rules. 28 May 2010
Pharmaceutical
Japanese drug major Astellas says it has extended its co-promotion agreement ' originally signed in December 2002 - for the angiotensin II receptor blocker antihypertensive Micardis (telmisartan) with its originator, Germany's Boehringer Ingelheim, for a further four years. 25 May 2010
Generics
The French Competition Authority has agreed to a request by the local subsidiary of Israel-based generics giant Teva Pharmaceutical Industries to investigate alleged anti-competitive practices by the country's leading pharmaceutical group Sanofi-Aventis aimed at preventing generic competition to its blood thinning treatment Plavix (clopidogrel). 21 May 2010
Pharmaceutical
US drug giant Merck & Co says that a new Phase III study with Brinavess (vernakalant) intravenous, an investigational compound being developed in the European Union by its subsidiary Merck Sharp & Dohme to treat atrial fibrillation, showed that the drug was superior to amiodarone injection, in converting patients' heart rate from atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of administration. 18 May 2010
Biotechnology
Actelion reports strong Ph II data with selexipag; says REVEAL study may advance patient care in PAH
Swiss biotechnology firm Actelion says that full data from the Phase II study of selexipag (proposed INN), the company's first-in-class, orally-available, selective IP receptor agonist in patients with pulmonary arterial hypertension (PAH) were presented by Gerald Simonneau, Chief of the Department of Pneumology, Hospital Antoine Beclere, Clamart, France, and Lead investigator on the trial, during the American Thoracic Society's 2010 international conference taking place this week in New Orleans, USA. 18 May 2010
Biotechnology
Netherlands-based biotechnology company Pharming Group NV said yesterday that it has initiated the process to reduce its financial interest in its wholly-owned subsidiary DNage BV in order to reduce the cash need and fully focus on the commercialization of its lead product Rhucin (recombinant human C1 esterase inhibitor), which is currently being reviewed by the European Medicines Agency (EMEA), with a decision expected in the third quarter of this year. 18 May 2010
Biotechnology
US drugs giant Merck & Co has entered into a collaboration with German firm ElexoPharm GmbH to develop and commercialize novel candidates targeting aldosterone synthase for the potential treatment of cardiovascular disease. 18 May 2010
Pharmaceutical
The World Health Organization says it welcomes the adoption last week of the United Nations General Assembly resolution on the prevention and control of non-communicable diseases - mainly cardiovascular diseases, cancers, chronic respiratory diseases and diabetes - which kill nearly 35 million people each year, including almost 9 million before the age of 60. The resolution seeks to halt the increasing trends in premature deaths from non-communicable diseases worldwide. 17 May 2010
Pharmaceutical
'Every day 75 Germans are killed by strokes,' said Cornelia Yzer, in a statement by the country's drug industry trade group the VFA to mark this week's Stroke Awareness Day. 'And many more are paralysed. Germany's pharmaceutical companies are therefore urgently working towards developing new drugs that lower the risk of strokes or facilitate treatment of stroke patients. Seven of these could be approved by the end of 2013,' she added. 14 May 2010
Biotechnology
US Food and Drug Administration news impacted negatively on French biotechnology firm NicOx, causing a setback for its osteoarthritis drug candidate, and for UK drugs giant GlaxoSmithKline, which has had to stop a trial of its Promacta (eltrombopag) in patients with thrombocytopenia due to chronic liver disease after a higher incidence of thrombosis was observed in patients taking the drug versus placebo. 13 May 2010
Generics
US drug giant Merck & Co has reached an agreement to settle the patent litigation involving Indian drugmaker Glenmark's challenge to Merck's patent covering the cholesterol lowering drug Zetia (ezetimibe). Specifically, Glenmark challenged Merck's basic compound patent, RE 37, on numerous grounds. 11 May 2010
Generics
The market for cardiovascular and metabolic generic drugs will be twice the size of the branded market by 2018 by volume, and account for 20% of the seven major market revenues, according to independent market analyst Datamonitor. However, increasing competition and lower profit margins could lead to quality control issues that threaten generic reputation and growth, it warns. 10 May 2010
Pharmaceutical
Danish insulin giant Novo Nordisk yesterday announced details of its cardiovascular outcomes trial for the type 2 diabetes agent Victoza (liraglutide [rDNA origin] injection), which is set to start in the fall of 2010. 7 May 2010
Generics
Last week, Brazil's Supreme Court of Justice (STJ) ruled that the validity of the patent which guarantees the right of exclusivity of US drugs behemoth Pfizer for the manufacture and marketing of the erectile dysfunction drug Viagra (sildenafil) expires on June 20. 4 May 2010
Pharmaceutical
Anglo-Swedish drug major AstraZeneca's cholesterol lowerer Crestor (rosuvastatin) has been approved in 19 countries within the European Union for the prevention of major cardiovascular events in patients who are at high risk of having a first cardiovascular event, the company announced this morning. 27 April 2010
Biotechnology
It was a good news day last Friday for Japan's biggest drugmaker, Takeda Pharmaceutical, which announced that New Drug Applications for five new products were approved by the Japanese Ministry of Health, Labor and Welfare, and that US biotechnology major Amgen had posted strong Phase III trial results for one of the compounds, Vectibix (panitumumab). 19 April 2010
Generics
US drug major Johnson & Johnson says that the Food and Drug Administration has approved Pancreaze Delayed Release Capsules, its pancreatic enzyme product (PEP), making it the third such product to receive agency clearance. 13 April 2010
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
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
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