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Pharmaceutical
There were some disappointments for two leading pharmaceutical companies yesterday, when data were presented at the American College of Cardiology annual meeting, held in Atlanta, which showed that potentially new strategies to prevent and treat diabetes and heart disease failed to improve therapy. 15 March 2010
Generics
Pharmaceutical companies will struggle to profit from the cardiovascular disease (CVD) market over the next decade, despite growing drug usage, according to Datamonitor. New research by the independent business analyst predicts that the CVD pharma market will grow from $99 billion in 2008 to $107 billion in 2018. 3 March 2010
Pharmaceutical
Zealand Pharma, a Danish biopharmaceutical firm specialized in the discovery and development of peptide-based drugs and PolyTherics, a spin-out company from Imperial College London and the London School of Pharmacy in the UK have entered into a research collaboration for novel, optimized biopharmaceutical products. 3 March 2010
Pharmaceutical
German independent dug major Boehringer Ingelheim's Pradaxa (dabigatran etexilate) will become one of the leading stroke prevention therapies in the atrial fibrillation drug market, generating blockbuster sales of $1.3 billion by 2018 in the leading markets of the USA, France, Germany, Italy, Spain, the UK and Japan, according to research firm Decision Resources. 3 March 2010
Pharmaceutical
Since the recent completion of its $41.1 billion takeover of fellow US drug major Schering-Plough, Merck & Co's integrated new R&D pipeline features a broad and diversified portfolio of investigational medicines and vaccines, including more than 20 candidates in Phase III or under regulatory review, and more than 20 candidates in Phase II of development, the group revealed yesterday. 2 March 2010
Biotechnology
Switzerland's Actelion yesterday saw its shares plunge 16.2% to 45.90 Swiss francs, its lowest level for four years, after the company announced the initial results of BUILD-3, a clinical study evaluating the safety and efficacy of its lead product bosentan (sold as Tracleer) in patients suffering from idiopathic pulmonary fibrosis (IPF). While there was a consistent trend in favor of bosentan, the primary endpoint, reduction in morbidity/mortality, was not met (p=0.21). However, the company noted, the well characterized safety profile of bosentan was confirmed. 2 March 2010
Pharmaceutical
Anglo-Swedish drug major AstraZeneca says that it will exercise one of its options under the provisions of the agreements relating to the restructuring of the AstraZeneca and Merck & Co joint venture in the USA, to get back rights to certain products, agreeing to pay its US partner $647 million for these in April. The UK-headquartered company's stock gained 1.6% to 29.31 in mid-afternoon London trading yesterday. 2 March 2010
Pharmaceutical
The European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) announced a number of decisions resulting from its February 15-19 meetings, including recommending the granting of a conditional marketing authorization for a fifth pandemic vaccine, Humenza (split virion, inactivated, AF03 adjuvanted influenza H1N1 pandemic vaccine), from Sanofi Pasteur, a unit of French drug major Sanofi-Aventis, intended for the prophylaxis of influenza in an officially declared pandemic situation. This recommendation was made using an emergency procedure which fast-tracks evaluation of new vaccines developed during a pandemic. 22 February 2010
Pharmaceutical
In a web site posting yesterday, the US Food and Drug Administration notified health care professionals about recent changes in the Prescribing Information (PI) for Swiss drug major Novartis' Exjade (deferasirox), indicated for the treatment of chronic iron overload due to blood transfusions in patients two years of age and older. New language was added to the Contraindications, Warnings and Precautions and Drug Interactions sections of the PI, including a Boxed Warning, that the product may cause: 19 February 2010
Pharmaceutical
Statin therapy is associated with a slightly increased risk of development of diabetes, but the risk is low both in absolute terms and when compared with the reduction in coronary events, say researchers in a report published in the prestigious medical journal The Lancet. However, they add, clinical practice in patients with moderate or high cardiovascular risk or existing cardiovascular disease should not change. 19 February 2010
Biotechnology
US biotech firm Biogen Idec and Stockholm-based Biovitrum (now called Swedish Orphan Biovitrum since completion of the merger between the two Swedish groups in January) have restructured the collaboration agreement for the companies' long-acting, recombinant Factor VIII Fc fusion protein (rFVIIIFc) in hemophilia A patients and the recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. 18 February 2010
Pharmaceutical
The US Food and Drug Administration has approved Japanese drug major Daiichi Sankyo's antihypertensive Benicar (olmesartan medoxomil) for use in children and adolescents aged six 16 years of age. Benicar was originally approved in 2002 for the treatment of hypertension in adults, and the company has forecast global current year sales of some $900 million for the drug, also sold as Olmetec. 12 February 2010
Pharmaceutical
Japan's Daiichi Sankyo and majority-owned Indian drugmaker and Ranbaxy Laboratories announced specific plans to introduce innovator products of the Japanese firm in Mexico through the marketing division that was created last year within Ranbaxy's Mexican subsidiary, Ranbaxy Mexico SA de CV last year (The Pharma Letter October 12, 2009). 11 February 2010
Biotechnology
Bombarding DNA nucleotides and mammalian meat with 'femto-neutrons' has opened up the path to 'femtomedicine,' an entirely new cancer diagnostics, it was reported yesterday at First Global Congress on NanoEngineering for Medicine and Biology in Houston, Texas, USA. 11 February 2010
Biotechnology
The UK's ReNeuron Group says that the UK Gene Therapy Advisory Committee (GTAC) has given a full and final Favorable Opinion for the firm's proposed first-in-man clinical trial with its ReN001 stem cell therapy for stroke. The GTAC acts as the national research ethics committee for gene therapy and stem cell therapy clinical trials in the UK. 10 February 2010
Pharmaceutical
The US Food and Drug Administration yesterday approved Anglo-Swedish drug major AstraZeneca's blockbuster cholesterol-lowerer Crestor (rosuvastatin calcium) for additional indications. Last year the drug, which is marketed under license from Japan's Shionogi, generated revenues for the UK-headquartered firm of $4.5 billion and $1.26 billion in the last three months of 2009, an increase of 20% on the like period of the previous year (The Pharma Letter January 28). 9 February 2010
Biotechnology
Swiss drug major Roche has announced a three to five-year joint research collaboration with Massachusetts General Hospital (Boston, USA) and Harvard University (Cambridge, USA) that will use stem cell technologies to advance drug discovery in areas of high unmet medical need. Financial terms were not disclosed. 5 February 2010
Pharmaceutical
Japanese drug major Daiichi Sankyo has initiated a new large-scale pivotal Phase III trial for edoxaban, its investigational oral Factor Xa inhibitor. This new study, called HOKUSAI VTE, is evaluating the safety and efficacy of edoxaban in reducing recurrent venous thromboembolic (VTE) complications in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE). 4 February 2010
Pharmaceutical
In addition to extensive generic erosion, the hypertension drug market will be constrained through 2018 by a pipeline containing very few emerging therapies with novel mechanisms of action, according to a new report from research and advisory firm Decision Resources. 3 February 2010
Pharmaceutical
There was a pleasant financial surprise yesterday for US health care giant Johnson & Johnson, after its subsidiary - Cordis - announced that it has reached a deal with Boston Scientific resolving two Delaware litigations related to Cordis' Palmaz and Gray patents and Boston Scientific's Jang patents. Under the terms of the agreement, Cordis will receive $1.725 billion from Boston Scientific and J&J expects to record the majority of this payment as a special item in the first quarter of 2010. 2 February 2010
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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