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Pharmaceutical
In a move that has been previously flagged, Anglo-Swedish drug major AstraZeneca's (LSE: AZN) is near to selling its Swedish dental and health care subsidiary in a deal that could bring in a handsome $1.8 billion to the company, according to a report this morning in the UK's Financial Times. 21 June 2011
Pharmaceutical
The UK's drug watchdog body the National Institute for Health and Clinical Excellence (NICE) last week issued draft guidance suggesting that GlaxoSmithKline's (LSE: GSK) epilepsy drug Trobalt (retigabine) and USA-based The Medicine Company's (Nasdaq: MDCO) heart drug Angiox (bivalirudin) should be available for use on the National Health Service. 20 June 2011
Pharmaceutical
US health care giant Johnson & Johnson (NYSE: JNJ), which has suffered a steady stream of bad news relating to product recalls, says that it expects to record an after-tax restructuring charge in the range of $500-$600 million in the second quarter of 2011 as a result of restructuring plans announced by its subsidiary, Cordis Corp. The restructuring charge will be treated as a special item. 17 June 2011
Pharmaceutical
The European Patent Office has invalidated one of the patents - EP1020461 - on Anglo-Swedish drug major AstraZeneca's (LSE: AZN) ulcer drug Nexium (esomeprazole), in a challenge from Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA) and 12 other generic drugmakers, according to a report by the Bloomberg news service. 13 June 2011
Pharmaceutical
The US Food and Drug Administration yesterday announced safety label changes for the cholesterol-lowering drug simvastatin, the now off patent once blockbuster drug Zocor from Merck & Co (NYSE: MRK), because the highest approved dose - 80mg -has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use. 9 June 2011
Pharmaceutical
French drug major Sanofi (Euronext: SAN) announced results at the American Society of Clinical Oncology (ASCO) meeting in Chicago of the pivotal SAVE-ONCO study which demonstrated that, in cancer patients initiating a chemotherapy regimen, investigational semuloparin significantly reduced the risk of the composite of symptomatic-deep vein thromboembolism (DVT), non-fatal pulmonary embolism (PE) or venous thromboembolism (VTE)-related death by 64%, meeting the study primary endpoint (respectively 1.2% and 3.4% for semuloparin and placebo HR 0.36 95% CI (0.21-0.60)), p< 0.0001). 7 June 2011
Pharmaceutical
The US Food and Drug Administration stated yesterday that a group of drugs used to control high blood pressure - angiotensin receptor blockers (ARBs) - do not increase the risk of developing cancer in patients using the medications. 3 June 2011
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) says that Health Canada has approved Brilinta (ticagrelor tablets) for the secondary prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). 2 June 2011
Pharmaceutical
Swiss pharmaceutical major Roche (ROG: SIX) and Russian TeaReks company, a subsidiary of ChemRar, Roche's long-standing partner, have signed a licensing agreement on the development of an innovative drug for patients at risk of thrombosis, according to the companies. 30 May 2011
Pharmaceutical
US health care major Johnson & Johnson (NYSE: JNJ) yesterday reviewed its growth strategies for its Pharmaceuticals business at a meeting with the investment community today. The company, which is in the process of launching six key pharmaceuticals products since 2009, said it plans to file for approval of 11 new drugs - and over 30 indication extensions - by 2015 as it moves to expand its pharmaceutical business. 27 May 2011
Pharmaceutical
US health care major Abbott Laboratories (NYSE ABT) has halted its AIM-HIGH clinical trial of Niaspan (niacin), started in September 2005, some 18 months ahead of schedule, after an interim analysis indicated that the cholesterol lowerer, in combination with simvastatin, not only failed to prevent heart attack, but may also raise the risk of ischemic stroke. 27 May 2011
Pharmaceutical
Synovate Healthcare, the health care specialist unit of market research firm Synovate, says it has launched its newest syndicated therapy monitor focusing on the drug treatment of patients with hyperlipidemia in Asia-Pacific. Hyperlipidemia, a condition of abnormally high blood lipid levels, is closely associated with a significant increase in the risk of cardiovascular disease. 27 May 2011
Generics
US Senate Finance Committee Chairman Max Baucus (Democrat, Montana) and senior Committee Member Chuck Grassley (Republican, Iowa) have sent a letter and a new Committee Report to the Food and Drug Administration detailing the financial relationship between the French pharmaceutical company Sanofi (Euronext: SAN) and physicians' groups that lobbied the agency against approving generic drugs that would compete with Sanofi products. 26 May 2011
Pharmaceutical
The National Institute for Health and Clinical Excellence (NICE) has today issued final guidance recommending naftidrofuryl oxalate as an option for the treatment of people who have intermittent claudication caused by peripheral arterial disease and for whom vasodilator therapy is considered appropriate after taking into account other treatment options. 26 May 2011
Pharmaceutical
Global drugs behemoth Pfizer (NYSE: PFE) has reported results from a sub-analysis of the Phase IIIb EMPHASIS-HF trial (n=2737) showing that its already marketed Inspra (eplerenone) plus standard therapy statistically significantly reduced the incidence of new onset atrial fibrillation in patients with systolic heart failure, compared with placebo plus standard therapy (2.7% versus 4.5%, respectively; HR 0.58; 95% CI: 0.35-0.96, p=0.034). 24 May 2011
Pharmaceutical
Following a positive recommendation from its drug advisory body (The Pharma Letter March 21), the European Commission has approved Eliquis (apixaban) in the 27 countries of the European Union for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. 23 May 2011
Pharmaceutical
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee to review the results of the ACCORD Lipid study as they relate to the use of fenofibric acid (sold as Trilipix in the USA by health care major Abbott Laboratories [NYSE: ABT]) in combination with a statin in patients with mixed dyslipidemia and at high risk of heart disease. 20 May 2011
Pharmaceutical
Following its expected launch in the USA in 2012 for venous thromboembolism (VTE) prophylaxis in medically ill patients, the overall uptake of German drug major Bayer (BAY: DE) and Johnson & Johnson (NYSE: JNJ) unit Ortho-McNeil's Xarelto (rivaroxaban) could be constrained in this indication by a perception of an increased risk of bleeding, says advisory firm Decision Resources. Nonetheless Xarelto will achieve blockbuster potential in the world's major pharmaceutical markets, it adds. 17 May 2011
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday announced three items of news regarding its potential blockbuster blood thinner Brilique/Brilinta (ticagrelor), which late last year gained European Marketing approval (The Pharma Letter December 6, 2010) but is still awaiting clearance in the all-important US market. 10 May 2011
Pharmaceutical
talian drugmaker Recordati SpA (REC: MI) has presented results for the first quarter of 2011 and its updated 2011-2013 Business Plan, which was approved by the board of directors. Consolidated revenue in the first quarter was 197.8 million euros ($286.9 million), up 6.4% compared to the same period of the preceding year, despite sales of its lead product, the antihypertensive Zanidip/Lercadip (lercanidipine) falling by 19.7% as a result of the entry of generics into the market following this product's patent expiry in January 2010. 10 May 2011
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
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. 23 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
Biotechnology
US RNAi therapeutics company Alnylam Pharmaceuticals has released two new data sets from the HELIOS-B Phase III study of Amvuttra (vutrisiran), an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). 30 September 2024
Biotechnology
Repair Biotechnologies, a company developing therapies to reverse atherosclerotic plaque, has entered into a collaboration with Genevant Sciences, a specialist in nucleic acid delivery technology. 27 September 2024
Biotechnology
Edgewise Therapeutics has announced promising top-line results for its candidate EDG-7500, aimed at treating hypertrophic cardiomyopathy (HCM). 20 September 2024
Pharmaceutical
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
Biotechnology
Canada’s NanoVation Therapeutics, a privately-held platform company developing innovative technologies to overcome the barriers of nucleic acid delivery, has announced a multi-year partnership with Danish drugmaker Novo Nordisk. 18 September 2024
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