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Biotechnology
A study published in The Lancet found that participants in a Phase I clinical trial saw their level of low density lipoprotein (LDL) cholesterol, or “bad” cholesterol, fall by up to 57% as a result of taking ALN-PCS. 4 October 2013
Biotechnology
Xention and Servier have entered into a multi-year agreement for the development and commercialization of XEN-D0103, a selective Kv1.5 modulator for AF) 2 October 2013
Pharmaceutical
GlaxoSmithKline says it has now reached agreement to sell its thrombosis brands, Arixtra and Fraxiparine, and the Notre-Dame de Bondeville, France, manufacturing site to Aspen Pharmacare for £700 million. 30 September 2013
Pharmaceutical
Swiss drug major Novartis has said it regrets the inconvenience caused by its investigator-initiated trails in Japan after it was accused of submitting research papers with manipulated data for the blood pressure drug valsartan. 27 September 2013
Pharmaceutical
French drug major Sanofi revealed today that construction has begun on its new Sidi Abdellah industrial site in Algeria. 26 September 2013
Pharmaceutical
Data from the Phase III EINSTEIN clinical trial program published Friday in the Thrombosis Journal underline that single-drug therapy with German drug major Bayer’s novel oral anticoagulant Xarelto (rivaroxaban) show the drug is effective in deep vein thrombosis and pulmonary embolism. 22 September 2013
article
Israel-based Teva Pharmaceutical Industries (NYSE: TEVA), the world biggest maker of generic drugs, on Friday launched a generic equivalent to Niaspan (niacin extended-release) tablets. 22 September 2013
Biotechnology
US biotechnology company Cytomedix (OTCQX: CMXI) will reorganize its R&D activities to reduce cash burn. As part of this initiative, the company’s ongoing financial support of the current RECOVER-Stroke trial and the underlying ALDH Bright Cell technology will be substantially concluded by the end of the year. 18 September 2013
Biotechnology
French drug major Sanofi's (Euronext: SAN) decision to withdraw Lyxumia's (lixisenatide)... 18 September 2013
Pharmaceutical
Canada-based Cardiome Pharma (TSX: COM) has entered into an agreement with Tzamal Medical to sell and distribute Brinavess (vernakalant intravenous) exclusively in Israel. Under the terms of the accord, Tzamal Medical has agreed to specific annual commercial goals for Brinavess. Financial details of the deal have not been disclosed. 18 September 2013
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) today announced that the US Food and Drug Administration (FDA) has accepted for review a New Drug Application for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL). 18 September 2013
Pharmaceutical
Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) has entered into a license, development and commercialization agreement with US privately-held Arbor Pharmaceuticals, to provide Arbor with exclusive rights to market and sell Edarbi (azilsartan medoxomil) and Edarbyclor (azilsartan medoxomil and chlorthalidone) in the US market effective September 12, 2013. 13 September 2013
Generics
Reversing a district court decision last year (The Pharma Letter May 30, 2012), the US Court of Appeals for the Federal Circuit ruled on September 12 that both Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) and Par Pharmaceuticals (NYSE: PRX) can go ahead with plans to launch generic copies of UK pharma giant GlaxoSmithKline (LSE: GSK) subsidiary Pronova's triglyceride lowerer Lovaza (omega-3-acid ethyl esters). 13 September 2013
Biotechnology
Canadian biotech firm Resverlogix (TSX:RVX) saw its shares rocket 40% to C$0.95 after it released a full data analysis from 281 treated patients in its Phase IIb ASSURE clinical trial evaluating RVX-208 using intravascular ultrasound (IVUS) in high-risk cardiovascular patients. Resverlogix stock plunged a record 93% in June after initial results from that trial showed RVX-208 had failed to meet its primary target (The Pharma Letter June 28). 6 September 2013
Generics
Ireland Health Service Executive's (HSE) Medicines Management Program (MMP) has identified two new preferred drugs as part of the second phase of the "Preferred Drugs Initiative." This is the first time the MMP has identified preferred drugs in the angiotensin-converting-enzyme (ACE) inhibitor and angiotensin II receptor blocker (ARB) drug category. 6 September 2013
Pharmaceutical
The US subsidiary of French drug major Sanofi (Euronext: SAN) has entered into a deal with US drugmaker Pozen (Nasdaq: POZN) to exclusively license the US firm's investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor (PPI), and enteric-coated (EC) aspirin in a single tablet (PA), PA8140 and PA32540. 4 September 2013
Pharmaceutical
German family-owned drug major Boehringer Ingelheim has announced new milestones for the novel oral anticoagulant Pradaxa (dabigatran etexilate) with over two million patient-years of experience in all licensed indications globally. 4 September 2013
Biotechnology
The ongoing European Society of Cardiology meeting in Amsterdam, Netherlands, continues to produce both positive and negative clinical trials results (see also recent stories by The Pharma Letter). 3 September 2013
Pharmaceutical
Results from a new analysis of the Phase III RELAX-AHF study published today in the European Heart Journal and presented as a late breaker at the European Society of Cardiology (ESC) congress in Amsterdam indicate that Swiss drug major Novartis' (NOVN: VX) investigational agent serelaxin (RLX030) consistently improved symptoms and mortality across multiple subgroups of patients with acute heart failure (AHF) assessed in the trial. 2 September 2013
Pharmaceutical
In patients with non-ST-elevation acute coronary syndrome (NSTE- ACS), pre-treatment with the P2Y12 antagonist prasugrel prior to catheterization, significantly increases the risk of life-threatening bleeding without reducing the risk of major ischemic events, according to the results of the ACCOAST (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction) trial. 2 September 2013
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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