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Pharmaceutical
A UK-based heart charity is calling on Members of Parliament and patients to protest against a decision to refuse funding for a new drug that could improve the lives of thousands of people with atrial fibrillation, a heart rhythm disorder, French drug major Sanofi-Aventis' Multaq (dronedarone), which the National Institute for Health and Clinical Excellence (NICE) last year declined to approve its use on National Health Service (The Pharma Letter December 24, 2009). 26 January 2010
Pharmaceutical
German drug major Bayer Schering Pharma AG, Germany has announced that an independent Data Safety and Monitoring Board has completed an interim analysis of a Phase II trial (the LIPLONG study) of the company's long-acting recombinant factor VIII, BAY79-4980. The DSMB concluded that the study will not be able to achieve the predetermined efficacy endpoint (non-inferiority). No safety concerns were raised. As a result of the DSMB findings and recommendation, Bayer has decided to discontinue the study. 25 January 2010
Generics
Leading Chinese over-the-counter medicines company China Sky One Medical says that its wholly-owned subsidiary Heilongjiang Tianlong Pharmaceutical will change its R&D focus from external use medicines to antibiotics and cardiac drugs. 22 January 2010
Pharmaceutical
French drugmaker Ipsen and California, USA-based Inspiration Biopharmaceuticals have entered into a partnership to create a world leading hemophilia franchise in order to develop drugs to treat hemophilia that could generate sales of over $1 billion by 2020 and could lead to Ipsen's eventual acquisition of the US firm. 21 January 2010
Pharmaceutical
Today, Taiho Pharmaceutical, the Japanese licensee of Switzerland-based Helsinn's second generation 5-HT(3) receptor antagonist palonosetron, gained marketing approval in Japan for the prevention of chemotherapy-induced nausea and vomiting (CINV) (including delayed phase) in patients with cancer. 20 January 2010
Pharmaceutical
US generic drugmaker Impax Laboratories confirmed that it has initiated a challenge to patents listed by Japanese drug firm Daiichi Sankyo in connection with its cholesterol-lowering product Welchol (colesevelam HCl) tablets, 625mg, including one that US biotech major Genzyme inherited when it acquired GelTex Pharmaceuticals in 2000. The patents are claimed to expire in 2014 and 2015. 18 January 2010
Pharmaceutical
Action against Australian plasma and vaccines producer CSL has continued to accelerate, since the US Federal Trade Commission blocked the firm's proposed $3.1 billion acquisition of the American firm Talecris Biotherapeutics last year on the basis of competition concerns and allegations of market manipulation, as CSL was already the second-largest blood-based medicines operator in the US market (The Pharma Letter June 9, 2009). 11 January 2010
Pharmaceutical
Spain's largest drugmaker Almirall saw its share price rise 3.9% to 9.51 euros in morning trading yesterday when - together with US licensee Forest Laboratories - it announced positive top-line results from ACCORD COPD I, a three-month Phase III study comparing their developmental chronic obstructive pulmonary disease (COPD) drug aclidinium (trade name Eklira) 200mcg and 400mcg BID versus placebo. 8 January 2010
Pharmaceutical
A hypertension drug that requires less-frequent dosing than Novartis's Diovan/Tareg (valsartan) would earn 30% patient share according to surveyed US cardiologists. Similarly, in Europe, such an agent would earn comparable patient share of 25% according to surveyed European cardiologists. These patient shares are significantly higher than Diovan/Tareg's current patient share (6.1%) and are higher than the patient share achieved by any current hypertension drug, states a new report from Decision Resources. 8 January 2010
Pharmaceutical
The European Commission has approved global drug behemoth Pfizer's Revatio (sildenafil) solution for injection for patients who are currently prescribed oral Revatio and who are temporarily unable to take oral medicine, but are otherwise clinically and hemodynamically stable. Pfizer's shares rose 3% to $18.75 on the news. 6 January 2010
Pharmaceutical
The US Food and Drug Administration has issued a Complete Response letter regarding global drugs behemoth Pfizer's New Drug Application for Lyrica (pregabalin) as a monotherapy treatment for generalized anxiety disorder (GAD). 24 December 2009
Pharmaceutical
The UK's National Institute for Health and Clinical Excellence (NICE) says it is currently appraising the use of French drug major Sanofi-Aventis' Multaq (dronedarone) for the treatment of atrial fibrillation. 24 December 2009
Pharmaceutical
US drug major Eli Lilly has signed an accord with Kowa Pharmaceuticals America, the US subsidiary of Japan's Kyowa, to commercialize Livalo (pitavastatin). The companies have also entered into a licensing agreement in Latin America. Financial terms of the deal have not been disclosed. 24 December 2009
Pharmaceutical
Novartis will gain exclusive worldwide rights to relaxin, a recombinant version of a naturally occurring human peptide, through the acquisition of the privately held US biopharmaceutical company Corthera. Relaxin is currently in Phase III clinical trials as a potential treatment option for patients with acute decompensated heart failure (ADHF). 23 December 2009
Pharmaceutical
Indian drug major Ranbaxy Laboratories, which is majority owned by Japan's Daiichi Sankyo, is to launch olmesartan medoxomil, an antihypertensive originally discovered by Daiichi Sankyo, in six African countries; Kenya, Mozambique, Nigeria, Tanzania, Uganda, and Zambia. The companies will market the products under the brand name Olvance, as soon as the necessary measures have been completed in each country. 23 December 2009
Pharmaceutical
In a move that will take it up to fifth place in global consumer health care ' and confirming its aims to expand in niche markets rather than through mega buys/mergers, French drug major Sanofi-Aventis says it has entered into a deal to acquire the US firm Chattem in a deal valuing the latter at some $1.9 billion. 22 December 2009
Pharmaceutical
German drugs major Bayer has returned most of the rights it acquired in 2007 to US firm ZymoGenetics' Recothrom (thrombin alfa, topical, recombinant). Effective January 1, 2010, ZymoGenetics regains full promotion rights in the USA and all ex-US rights except in Canada, where Bayer will market and sell the product. The drug is used to control bleeding during surgeries. 22 December 2009
Pharmaceutical
At its meetings last week, Europe's Committee for Medicinal Products for Human Use (CHMP) gave out doses of disappointing medicine for the UK's Ark Therapeutics and on the future of benfluorex-containing medicines, but also gave its backing to several new drugs applying for approval, as well as updating on influenza vaccines and sibutramine. 21 December 2009
Pharmaceutical
As was widely expected following informal comments from a reviewer a few days ago (The Pharma Letter December 14), the US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee has voted 12 yes, four no, and one abstention that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of its blockbuster cholesterol-lowerer Crestor (rosuvastatin calcium) in individuals meeting the following criteria: 16 December 2009
Biotechnology
German drug major Bayer Schering Pharma has withdrawn its application for a centralized marketing authorization for the medicine Recothrom (thrombin alfa) 1,000 IU/ml, which was submitted to the European Medicines Agency (EMEA) in August 2008. 16 December 2009
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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