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Generics
Reimbursement Intelligence, a USA-based market-research firm, has announced how payers predict the impact of US drugs behemoth Pfizer's (NYSE: PFE) radical strategy relating to its just off-off patent in the USA all-time best selling pharmaceutical product Lipitor (atorvastatin) to stay in favor of consumers (The Pharma Letter December 1). 6 December 2011
Generics
Three prominent US Senators have sent letters to pharma behemoth Pfizer (NYSE: PF), as well as three companies that manage pharmaceutical benefits and two insurance firms, asking for information about agreements aimed at limiting the sale of atorvastatin, the generic equivalent of Pfizer's drug Lipitor, which lost patent protection in the USA on Wednesday. So-called 'authorized' copy versions - with 180 days of market exclusivity - of the all-time blockbuster cholesterol lowerer have already been launched by Watson Pharmaceuticals and Ranbaxy Laboratories (The Pharma Letter December 1). 2 December 2011
Generics
US generic drug major Mylan (Nasdaq: MYL) yesterday confirmed that it and Famy Care have been sued by Warner Chilcott in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for norethindrone and ethinyl estradiol 0.8mg/0.025mg and ferrous fumarate chewable tablets. 2 December 2011
Pharmaceutical
Israel's Compugen (Nasdaq: CGEN) and USA-based DiscoveRx have entered into a partnership for the purpose of commercializing novel Compugen designed peptides to be matched with specific G protein-coupled receptor (GPCR) targets utilizing DiscoveRx GPCR related technologies. The new agreement follows a successful pilot program between the two companies. 1 December 2011
Pharmaceutical
The acute coronary syndrome (ACS) drug market in Brazil will nearly double from $122 million in 2010 to $229 million in 2015, according to advisory firm Decision Resources new Emerging Markets report, Acute Coronary Syndrome in Brazil. 1 December 2011
Generics
US generic drug major Watson Pharmaceuticals (NYSE: WPI) was the first to confirm yesterday that it has launched an authorized generic version of pharma behemoth Pfizer's (NYSE: PFE) all-time blockbuster cholesterol lowerer Lipitor (atorvastatin) as part of an exclusive agreement with Pfizer, saying that it will be the largest generic product launch in US history. However, investors failed to be impressed, as Watson's shares fell 4% to $64.62 in a sharply higher overall market (the Nasdaq rose 4.2%). 1 December 2011
Pharmaceutical
Following a positive advisory recommendation in September, the European Commission has now approved Swiss drug major Novartis' (NOVN: VX) Rasitrio, the first triple combination of aliskiren, amlodipine and hydrochlorothiazide (HCT) in a single pill for the treatment of hypertension, the company revealed this morning. 28 November 2011
Pharmaceutical
In a batch of mixed news coming from the UK's National Institute for Health and Clinical Excellence (NICE) this morning, the agency has issued final draft guidance not recommending the use of Erbitux (cetuximab) from Merck Serono, a unit of Germany's Merck KGaA (MRK: DE), Swiss major Roche's (ROG: SIX) Avastin (bevacizumab) and US biotech firm Amgen's Vectibix (panitumumab) for the treatment of metastatic colorectal cancer that has progressed after first line chemotherapy. 25 November 2011
Pharmaceutical
The acute coronary syndrome (ACS) drug market in China will grow from $326 million in 2010 to $448 million in 2015. According to advisory firm Decision Resources' Emerging Markets report, Acute Coronary Syndrome in China, Anglo-Swedish drug major AstraZeneca's (LSE: AZN) Brilinta (ticagrelor) will exceed sales of French drugmaker Sanofi's (Euronext: SAN) Plavix (clopidogrel) in the treatment of ACS, making Brilinta the top Western brand in the ACS therapeutic market in China in 2015. 22 November 2011
Pharmaceutical
USA-based Adeona Pharmaceuticals (NYSE Amex: AEN) and the Human Therapeutics Division of Intrexon Corp have entered into a global exclusive channel collaboration to develop and commercialize a DNA-based therapeutic using Intrexon's UltraVector platform and RheoSwitch Therapeutic System for the treatment of pulmonary arterial hypertension (PAH). 22 November 2011
Pharmaceutical
The European Medicines Agency on Friday providing an update on the safety of independent German drug major Boehringer Ingelheim's anticoagulant Pradaxa (dabigatran etexilate) saying that, with the current warnings, the side effects of the drug are manageable. 20 November 2011
Generics
Iceland-headquartered generic drug major Actavis Group revealed on Friday that it has launched Valsartan and Valsartan HCT in nine European countries immediately after the patents expired on November 12 and 13. 20 November 2011
Pharmaceutical
Researchers at Emory University School of Medicine, USA, have identified hepcidin, a hormone that regulates iron levels in the body, as a potential target for treating atherosclerosis. 17 November 2011
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) presented mixed results from a study comparing its cholesterol lowerer Crestor (rosuvastatin) to all time blockbuster drug Lipitor (atorvastatin) from Pfizer (NYSE: PFE), at the American Heart Association meeting this week. Although Crestor outperformed Lipitor, which is set to face generic competition in the USA at the end of this month, on some measures it failed to demonstrate overall superiority. 16 November 2011
Pharmaceutical
The European Medicines Agency says it has been formally notified by Merck Sharp & Dohme (Europe), a subsidiary of US drug giant Merck & Co (NYSE: MRK) of its decision to withdraw its application for a centralized marketing authorization for the medicine Janacti (sitagliptin and pioglitazone) and related trade names, 100/30mg and 100/45mg fixed-dose combination tablets intended to be used for the treatment of adult patients with type 2 diabetes mellitus. 15 November 2011
Pharmaceutical
The US unit of Germany's Bayer (BAY: DE) yesterday announced that the combination of oral Xarelto (rivaroxaban) twice daily with standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome (ACS) compared to those receiving standard antiplatelet therapy alone. In addition, rivaroxaban 2.5mg in combination with standard therapy significantly reduced mortality over standard therapy alone. 14 November 2011
Pharmaceutical
French drug major Sanofi (Euronext: SAN) and USA-based Regeneron (Nasdaq: REGN) have reported positive preliminary results from the Phase II study of their anti-PCSK9 antibody, REGN727/SAR236553 in hypercholesterolemia patients. Those who received REGN727 saw their low-density lipoprotein, or 'bad cholesterol,' drop 65%, compared to just 17% of those who received an increased dose of Pfizer's blockbuster Lipitor (atorvastatin). 14 November 2011
Pharmaceutical
US pharma giant Merck & Co (NYSE:MRK) hosted an upbeat R&D and Business Briefing yesterday, where it announced an 11% increase to $0.42 in its quarterly dividend payment, the first time in seven years and seeing the firm's shares rise 3.5% to $34.97, compared with a 1% gain in the Dow Jones Industrial Average. 11 November 2011
Generics
The US subsidiary of Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday launched a new savings card which allows eligible patients to get their prescription for the firm's cholesterol lowerer Crestor (rosuvastatin) for just $8 more than the average co-pay of a generic statin. Eligible patients can pay just $18 for a prescription of Crestor (up to 30 tablets), noted AstraZeneca. 7 November 2011
Pharmaceutical
In what was much-awaited good news for German drug major Bayer (BAY: DE), its US subsidiary announced late Friday (November 4) that the US Food and Drug Administration had finally approved its blood thinner Xarelto (rivaroxaban) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Bayer's shares rose 3.9% to 46.65 euros in morning trading today, in a falling German market. 7 November 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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