Cardio-vascular
Refine Search
Pharmaceutical
The German Federal Joint Committee (G-BA), the supreme decision-making body of the self-governing medical system in Germany, says that it considers the use of Japanese drug major Eisai's (TYO: 4523) Halaven (eribulin) to have additional benefit versus comparative treatments, defined by the G-BA for women who have already had extensive prior treatment of metastatic or locally advanced breast cancer. The decision comes despite a negative initial assessment by the G-BS's advisory body, the IQWiG (The Pharma Letter February 17). 23 April 2012
Pharmaceutical
In a day of mixed news for the Swiss drug major, Novartis (NOVN: VX) said yesterday that it has updated its hypertension drug Tekturna/Rasilez (aliskiren) label in consultation with the US Food and Drug Administration to include warning against the combined use of aliskiren-based products with ACE inhibitors or angiotensin receptor blockers (ARBs) in patients with diabetes. 20 April 2012
Generics
Japanese drug major Daiichi Sankyo (TYO: 4568) and its majority-owned Indian subsidiary Ranbaxy Laboratories (AB: BO) announced today that the latter's Terapia Ranbaxy unit will launch Sevikar, a fixed dose combination of olmesartan medoxomil and amlodipine besylate tablets, in Romania. 19 April 2012
Generics
US generic drug major Mylan (Nasdaq: MYL) revealed last Friday that it has begun shipping its generic version of the lipid-lowerer Lescol (fluvastatin), after its subsidiary Mylan Pharmaceuticals received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for fluvastatin capsules USP, 20mg and 40mg, the first generic copy of the branded product from Swiss pharma major Novartis (NOVN: VX). 16 April 2012
Pharmaceutical
In the USA, formulary inclusion of the new anticoagulant Xarelto (rivaroxaban) from German drug major Bayer (BAY: DE), and the new antiplatelet Brilinta (ticagrelor) from Anglo-Swedish AstraZeneca (LSE: AZN) is high among surveyed institutions, either on open or restricted formulary access, despite having gained Food and Drug Administration approval only within the past year. 3 April 2012
Pharmaceutical
Forest Laboratories, (NYSE: FRX) says it has acquired all US patents and other US and Canadian intellectual property from Janssen Pharmaceutica, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), for the antihypertensive Bystolic (nebivolol), which is currently approved in the USA for the treatment of hypertension, thereby eliminating all future royalties. 3 April 2012
Pharmaceutical
In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined the clot-inhibiting drug Eliquis (apixaban) from USA-based Pfizer (NYSE: PFE) and Bristol-Myers Squibb (NYSE: BMY), finding proof of minor added benefit for adult patients who had undergone hip replacement: symptomatic clots in the deep veins of the leg occurred less frequently with apixaban treatment than with the comparator therapy. 2 April 2012
Pharmaceutical
Biotech firm Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN), has submitted a New Drug Application to the US Food and Drug Administration seeking approval for Kynamro (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), a rare cholesterol disorder. 2 April 2012
Generics
Israeli generics giant Teva Pharmaceutical Industries (Nasdaq: TEVA) last Friday launched an authorized generic of Provigil (modafinil), a drug for the treatment of narcolepsy, the patent on which expires in 2014. 1 April 2012
Pharmaceutical
Scientists from the Florida, USA, campus of The Scripps Research Institute have synthesized a pair of small molecules that dramatically alter the core biological clock in animal models, highlighting the potential effectiveness of these compounds in treating a remarkable range of disorders - including obesity, diabetes, high cholesterol and serious sleep disorders. The study was published on March 29, 2012, in an advance, on-line edition of the journal Nature. 1 April 2012
Pharmaceutical
Following the receipt of further evidence from Bayer HealthCare, a unit of German drugmaker Bayer (BAY: DE), of the clinical and cost effectiveness of its Xarelto (rivaroxaban), UK drug watchdog the National Institute of Health and Clinical Excellence (NICE) this morning published final draft guidance recommending the drug as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation. 30 March 2012
Pharmaceutical
Pulmonary embolism - the sudden blockage of an artery in the lung - is estimated to cause over 100,000 deaths each year in the US Although thrombolytics, or clot-buster drugs, are currently reserved to treat only the most severe cases of pulmonary embolism, new data suggest that when used at lower doses, these drugs are also safe and effective for more common, moderate cases of pulmonary embolism, according to research presented today at the American College of Cardiology 61st Annual Scientific Session. 28 March 2012
Pharmaceutical
German drugs and crops sciences group Bayer (BAY: DE), and partner Janssen, part of US health care major Johnson & Johnson (NYSE: JNJ), yesterday released new study results showing that their oral anticoagulant Xarelto (rivaroxaban), the first single drug intervention for the treatment of venous blood clots, has a comparable safety profile and is as effective as the current dual drug approach of enoxaparin followed by Vitamin K antagonist (VKA) in treating patients with acute symptomatic pulmonary embolism (PE) and preventing the development of secondary venous blood clots. 27 March 2012
Pharmaceutical
Confirming earlier mixed top-line results, US drug giant Merck & Co (NYSE: MRK; The Pharma Letter February 8) presented results from the TRA-2P (Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) TIMI 50 study of vorapaxar, its investigational anti-thrombotic drug, in patients with a prior history of cardiovascular events or disease. 26 March 2012
Pharmaceutical
USA-based Pozen (Nasdaq: POZN) saw its shares leap 9% to $5.24 on Thursday morning, having risen nearly 20% to a six-month high of $5.73 earlier in the session, after the company revealed that aspirin combination drug helps prevent gastric ulcers in aspirin users and that it plans to file for US marketing approval in the third quarter of this year. 23 March 2012
Pharmaceutical
ug giant Merck & Co (NYSE: MRK) has discontinued further development of the oral formulation of vernakalant, which is the subject of a licensing deal with Canada-based Cardiome Pharma (Nasdaq: CRME). Cardiome shares dropped $1.01 to $0.90 in morning trading on the Toronto Stock Exchange yesterday. 20 March 2012
Pharmaceutical
The Pharmaceutical Management Agency of New Zealand, PHARMAC, has announced reaching agreement with US drug major Eli Lilly (NYSE: LLY) to approve listing of its drug Effient (prasugrel) for use by patients allergic to clopidogrel, the blockbuster blood thinner Plavix from Sanofi. 19 March 2012
Generics
USA-based Watson Pharmaceuticals (NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market niacin extended-release tablets, 500mg and 1,000mg, generic versions of Niaspan, a cholesterol-lowerer marketed by health care major Abbott Laboratories (NYSE: ABT). 19 March 2012
Pharmaceutical
There is a wide gender divide when it comes to how men and women in the USA are prescribed and adhere to their medications. According to a new study, while women use more prescription drugs than men, they are less likely to be prescribed drugs according to clinical guidelines and are not as good about adhering to the medications they are prescribed. 19 March 2012
Pharmaceutical
Japanese drug major Takeda Pharmaceutical (TYO: 4502) and Norway-based lipid therapies specialist Pronova Biopharma (PRON: NO) reported results from a Phase III study in Japan showing that TAK-085 produced a triglyceride percent change of -10.93% and -22.65% in the 2g and 4g doses (p<0.0001), respectively compared to -11.30% in the eicosapentaenoic acid ethyl ester 1.8g group in hyperlipidemia patients. 19 March 2012
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze