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Pharmaceutical
In draft guidance published yesterday (February 1) the UK's National Institute for Health and Clinical Excellence (NICE) recommends the use of naftidrofuryl oxalate (the active ingredient in German drug major Merck KGaA's brand product Praxilene) as a treatment option for people who suffer from the painful symptoms of peripheral arterial disease called intermittent claudication. 2 February 2011
Generics
US generics drug major Mylan (Nasdaq: MYL) says that it has entered into two patent settlement agreement with global pharma behemoth Pfizer (NYSE: PFE). The first resolves litigation related to cardiovascular agent Caduet (amlodipine besilate and atorvastatin) 2.5 mg/10, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. 26 January 2011
Pharmaceutical
In some good news for French drug major Sanofi-Aventis (Euronext: SAN) and US partner Bristol-Myers Squibb (NYSE: BMY), the companies revealed in a joint statement that the US Food and Drug has granted an additional six-month period of exclusivity to market their blockbuster blood thinner Plavix (clopidogrel). In the USA, the Plavix patent is now scheduled to expire on May 17, 2012, that than in November this year. 26 January 2011
Generics
Global generic drug major Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced yesterday that it has received correspondence from the US Food and Drug Administration regarding the company's Abbreviated New Drug Application for generic Lovenox (enoxaparin sodium) injection. 26 January 2011
Pharmaceutical
The European Medicines Agency's advisory body, the Committee the Committee for Medicinal Products for Human Use (CHMP), at its January meeting last week adopted positive opinions recommending the granting of marketing authorizations for the following new medicines: 24 January 2011
Pharmaceutical
European drug majors Anglo-Swedish AstraZeneca (LSE: AZN) and Germany's Merck & Co (MRK: DE) gave updates this morning on products that have been stuck n the regulatory process, the former regarding the US filing for its blood thinner candidate Brilinta (ticagrelor) and the latter on its European filing for cladribine as an oral treatment for multiple sclerosis. 21 January 2011
Pharmaceutical
Spanish drugmaker Laboratorios Farmaceuticos Rovi says in a regulatory filing that it will soon be marketing the cholesterol lowerers Vytorin (ezetimibe and simvastatin) and Absorcol (ezetimibe) in Spain, the first of the five marketing licenses for its products that Merck Sharp & Dohme, the operating name for US drugs giant Merck & Co (NYSE: MRK) in Europe, awarded to Rovi as part of the strategic marketing and manufacturing agreement of July 23, 2009. 19 January 2011
Pharmaceutical
The US Food and Drug Administration on Friday notified health care professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with French drug major Sanofi-Aventis' (Euronext: SAN) anti-arrythmic Multaq (dronedarone). Information about the potential risk of liver injury from dronedarone is being added to the Warnings and Precautions and Adverse Reactions sections of the dronedarone labels, the agency said. 17 January 2011
Pharmaceutical
US pharma giant Merck & Co (NYSE: MRK) suffered a setback yesterday, seeing its shares slump 7% to $35.00 in early trading, after the company said it was halting one late-stage study of its experimental blood-thinner vorapaxar and modifying a second trial due to safety concerns. 14 January 2011
Biotechnology
Russian nanotech giant Rusnano, in cooperation with Human Stem Cell Institute (HSCI) - one of Russia's leading biotechnology companies, is considering investing more than 3 billion roubles ($97.5 million) in the development of innovative pharmaceuticals based on a number of modern technologies, including the post-genomic. The new drugs are expected be positioned as a treatments for some serious, socially significant diseases. 13 January 2011
Pharmaceutical
A computer decision model suggests that, for patients with a history of bleeding within the brain, the risk of recurrence associated with statin treatment may outweigh the benefit of the drug in preventing cardiovascular disease, according to a report posted on-line this week that will appear in the May print issue of Archives of Neurology, one of the JAMA/Archives journals. 12 January 2011
Pharmaceutical
Bayer files for EU approval of anticoagulant rivaroxaban for stroke prevention; updates on US filing
German drug major Bayer (BAY: DE) has submitted an application for marketing authorization to the European Medicines Agency (EMA) for its oral anticoagulant rivaroxaban in stroke prevention in patients with atrial fibrillation (SPAF), as well as for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE). 6 January 2011
Generics
Indian drugmaker Lupin, together with its US subsidiary, Lupin Pharmaceuticals, says it has settled all ongoing litigation over the sedative Lunesta (eszopiclone) tablets, thereby dismissing a patent suit brought by the drug's manufacturer, Japan's Dainippon Sumitomo Pharma's US subsidiary Sunovion Pharmaceuticals. 5 January 2011
Generics
Privately-held Amphastar Pharmaceuticals has filed with the US District Court for the District of Columbia an Amended Complaint for Declaratory and Injunctive Relief against the US Food and Drug Administration in company's continuing battle to win approval of the its long-pending Abbreviated New Drug Application for a generic version of French drug major Sanofi-Aventis (Euronext: SAN) blockbuster anti-coagulant drug Lovenox (enoxaparin sodium injection), which generated sales of $4.57 billion for the latter firm in 2009. 5 January 2011
Pharmaceutical
In a flurry of year-end activity, the US Food and Drug Administration yesterday approved Swiss drug major Novartis' (NOVN: VX) Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure as well as Watson Pharmaceuticals' (NYSE: WPI) new chewable oral contraceptive. But it also issued a complete response letter delaying the approval of Alimera Sciences' (Nasdaq: ALIM) ophthalmic product Iluvien (fluocinolone acetonide intravitreal insert). 24 December 2010
Biotechnology
Anglo-Swedish drug major AstraZeneca (LSE: AZN) last evening notified its partner Abbott Laboratories (NYSE: ABT) that it will discontinue the development of Certriad (rosuvastatin calcium and fenofibric acid), which was being investigated for the treatment of mixed dyslipidemia. This means the co-development and license agreement with Abbott will end on 22 January 22, 2011. 23 December 2010
Pharmaceutical
US drug behemoth Pfizer (NYSE: PFE) - which just a couple of weeks ago dumped its chief executive Jeff Kindler (The Pharma Letter December 6) - went on something of a spending spree yesterday, revealing two multi-billion licensing deals, one with San Diego, USA-based Lpath (OTC.BB: LPTN) and the other with Australian biotechnology firm Phylogica (ASX: PYC), with the aim of boosting its R&D pipeline that has seen a number of recent failures and is facing impending patent expiries including that of its top-selling ever drug, the cholesterol lowerer Lipitor (atorvastatin). 21 December 2010
Pharmaceutical
The European subsidiary of Japanese drug major Daiichi Sankyo (TKO: 4568) said yesterday that its antihypertensive Sevikar HCT is now approved in Germany, the first market to launch this new once-daily three-in-one combination product for the treatment of high blood pressure (BP). This new drug combines the three widely prescribed blood pressure treatments - olmesartan medoxomil, amlodipine, and hydrochlorothiazide (HCT) - in one single pill to help effectively control hypertension. 21 December 2010
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) received a setback yesterday, when the US Food and Drug Administration issued a complete response letter with regard to the firm's New Drug Application for its blockbuster potential blood thinner Brilinta (ticagrelor), which is expected to rival the world's second best-selling drug, Sanofi-Aventis' antiplatelet agent Plavix (clopidogrel), with sales of $9.8 billion last year. News of the delay saw the London-headquartered firm's shares fall 4.7% to 30.04 in morning trading today. 17 December 2010
Pharmaceutical
Germany's Evotec AG (FSE: EVT), via its subsidiary Develogen AG, has entered into a license and collaboration agreement with Anglo-Swedish drug major AstraZeneca's (LSE: AZN) USA-based biologics subsidiary MedImmune in the diabetes therapeutic area, with a particular focus on the regeneration of insulin producing beta cells. 16 December 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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