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Pharmaceutical
Orexigen Therapeutics (Nasdaq: OREX) saw its shares rocket 16.7% to $3.36 in morning trading yesterday, after announcing additional data showing that overweight and obese patients treated with its obesity drug candidate Contrave (naltrexone sustained release (SR)/bupropion SR) maintained normal 24-hour circadian patterns ' blood pressure - over one year of treatment. 5 April 2011
Pharmaceutical
Following a positive advisory panel earlier this year, the European Commission has granted marketing authorization for Trobalt (retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalization in adults aged 18 years and above with epilepsy. 31 March 2011
Pharmaceutical
For more than five million Americans with heart failure, a critical step to better health is taking the medications they are prescribed. But many patients fail to do so, putting themselves at greater risk of hospitalization and even death. 31 March 2011
Pharmaceutical
As a result of a further review of its developmental drug portfolio, US drug giant Merck & Co (NYSE: MRK) plans to return to privately-held Portola Pharmaceuticals all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation (SPAF). 25 March 2011
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) said it has withdrawn a reimbursement application for its potentially blockbuster blood thinner Brilique (ticagrelor, also using the brand name Brilinta for the USA) in France after an advisory agency requested more information about the drug's medical benefit. 25 March 2011
Pharmaceutical
More than 50% of surveyed US orthopedic surgeons and 70% of surveyed managed care organizations' (MCOs) pharmacy directors chose enoxaparin (Sanofi-Aventis' Lovenox, generics) as the most effective anticoagulant for venous thromboembolism (VTE) primary prophylaxis following major orthopedic surgery, when compared to other available therapies, according to advisory firm Decision Resources. Enoxaparin is the patient-share-leading parenteral anticoagulant for VTE prophylaxis following orthopedic surgery in the world's major pharmaceutical markets. 24 March 2011
Biotechnology
For the treatment of pulmonary arterial hypertension (PAH), the highest proportion of US surveyed pulmonologists (35%) identified Swiss biotech Actelion's (SIX: ATLN) Tracleer (bosentan) as the most effective therapy, when compared to other available therapies, according to research from advisory firm Decision Resources. However, only 15% of surveyed managed care organizations' (MCO) pharmacy directors chose Tracleer as the most effective treatment for PAH. 18 March 2011
Pharmaceutical
Men who take a certain class of cholesterol-lowering medicine, otherwise known as statins, may be 60% less likely to be diagnosed with high-grade prostate cancer. Some of the results of this powerful study involving more than 55,000 men were discussed at the Prostate Cancer Research Program's (PCRP's) Innovative Minds in Prostate Cancer Today (IMPaCT) conference in Orlando, Florida, USA, a gathering of some of the nation's most prestigious scientists and clinicians in prostate cancer research. 15 March 2011
Pharmaceutical
A Regional Court in Rio de Janeiro declined to extend the validity of two patents relating to Sanofi-Aventis (Euronext: SAN)/Bristol-Myers Squibb's (NYSE: BMY) antihypertensive Aprovel (irbesartan) and Pfizer's (NYSE: PFE) atypical antipsychotic Geodon (ziprasidone). 2 March 2011
Pharmaceutical
The US Food and Drug Administration on Friday approved Edarbi (azilsartan medoxomil), from Japan's largest drugmaker Takeda (TSE: 4502), to treat high blood pressure (hypertension) in adults, and also gave full approval for GlaxoSmithKline's (LSE: GSK) Promacta. 28 February 2011
Pharmaceutical
The US affiliate of Japan's largest drugmaker, Takeda Pharmaceutical ((TSE: 4502), has submitted a New Drug Application to the Food and Drug Administration for an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone (CLD) for the treatment of hypertension. 25 February 2011
Pharmaceutical
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Swiss drug major Novartis' (NOVN: VX) Rasilamlo (aliskiren and amlodipine) to treat high blood pressure patients not adequately controlled by either aliskiren or amlodipine alone. Rasilamlo combines in a single pill the only approved direct renin inhibitor worldwide, Rasilez, with the widely used calcium channel blocker amlodipine. The CHMP recommendation forms the basis for a European Commission licensing decision, which is expected in around three months. 21 February 2011
Pharmaceutical
The recently-approved drug dabigatran is recommended as an alternative to warfarin to help prevent dangerous blood clots in patients with atrial fibrillation, according to updated guidelines from the American College of Cardiology, American Heart Association and the Heart Rhythm Society. 16 February 2011
Generics
Brazil's health authority, ANVISA, has licensed the generic version of tenofovir to the official laboratory Fundacao Ezequiel Dias (Funed - run by the government of the state of Minas Gerais). This means nine million pills will begin to be produced as of next week, saving Brazil approximately 410 million reals ($244.7 million) by 2015. Currently, about 64,000 AIDS and 1,500 hepatitis patients in Brazil take tenofovir. 14 February 2011
Pharmaceutical
Canada's Valeant Pharmaceuticals International (TSX: VRX) went on another shopping spree yesterday, with its subsidiary, Biovail Laboratories International acquiring the Canadian rights to Cholestagel (colesevelam), an oral bile acid sequestrant for hypercholesterolemia, from Genzyme, which will receive a $2 million upfront payment from Biovail, to be followed by subsequent additional milestone payments totaling up to $7 million. 11 February 2011
Pharmaceutical
Treating mild strokes with the clot-busting drug approved for severe stroke could reduce the number of patients left disabled and save $200 million a year in disability costs, according to new research from the University of Cincinnati, USA. 11 February 2011
Pharmaceutical
Strong diabetes growth will not be enough to stop the cardiovascular and metabolic market from declining, according to independent market analyst Datamonitor. 10 February 2011
Pharmaceutical
The Brazil government will provide free medicine for diabetes and hypertension to Brazilians, starting from mid-February, the country's new President Dilma Rousseff announced last week, according to the Xinhau news agency. 7 February 2011
Pharmaceutical
In another delay for the approval of Anglo-Swedish drug major AstraZeneca's (LSE: AZN) potentially blockbuster blood thinner Brilinta (ticagrelor), the company revealed this morning that the US Food and Drug Administration has acknowledged receipt of the company's reply to the Complete Response Letter (CRL) for the drug's New Drug Application. Accordingly, the agency has accepted AstraZeneca's resubmission of the ticagrelor NDA, categorised it as a Class 2 resubmission to the CRL, and set a new PDUFA date of 20 July 2011. 4 February 2011
Pharmaceutical
Nearly 300 medicines in development in USA for two leading causes of death: heart disease and stroke
Drug discoveries played a major role in reducing American deaths from heart attacks and stroke by 28% between 1997 and 2007, yet cardiovascular disease still claims an American life every 39 seconds. 3 February 2011
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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