Cardio-vascular
Refine Search
Generics
The European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization for Twynsta (telmisartan/amlodipine), from independent German drug major Boehringer Ingelheim. The drug is intended for the treatment of essential hypertension. The review for Twynsta began on 23 September 2009 with an active review time of 210 days. 26 July 2010
Pharmaceutical
Japan-headquartered drugmaker Kowa said yesterday that, following the completion of the decentralized regulatory procedure, its statin drug pitavastatin has achieved a positive outcome from the UK Regulatory Authority (MHRA) acting as the Reference Member State for 16 European Union countries. 23 July 2010
Pharmaceutical
Commenting on the upcoming US Food and Drug Administration's review of Anglo-Swedish major AstraZeneca's blood thinner drug candidate, Nomura analyst Amit Roy says that, 'though we are yet to see (critical, yet unpublished) data comparing Brilinta (ticagrelor) with US standard of care Plavix [clopidogrel, from French major Sanofi-Aventis] 600mg, we remain concerned that the FDA's 19 July 2010
Generics
Gilead Sciences says it has filed a law suit in US District Court in New Jersey, USA, against Indian-owned Lupin for infringement of its patents for angina drug Ranexa (ranolazine extended-release tablets). The action is based on an Abbreviated New Drug Application filed by Lupin, which seeks approval to manufacture and market a generic version of Ranexa before the expiration of the drug's patents. 16 July 2010
Pharmaceutical
US health care giant Johnson & Johnson has entered into a definitive agreement to acquire Micrus Endovascular, a global developer and manufacturer of minimally invasive devices to address hemorrhagic and ischemic stroke, in a cash for stock exchange. 13 July 2010
Pharmaceutical
The launch and uptake of novel oral anticoagulants and anti-arrhythmic agents - specifically, drugs from Boehringer Ingelheim, Bayer/Johnson & Johnson, Bristol-Myers Squibb/Pfizer and Sanofi-Aventis - will drive the atrial fibrillation drug market to increase more than eight-f 9 July 2010
Pharmaceutical
The European Commission has approved a new chewable form of global drugs behemoth Pfizer's Lipitor (atorvastatin) suitable for use in children aged 10 or older with high levels of low-density lipoprotein ("bad") cholesterol and high triglycerides due to the inherited disorder familial hypercholesterolemia and other primary causes, which can increase the risk of heart disease and premature death. This pediatric indication has also been approved for the currently available tablet form of Lipitor. 6 July 2010
Generics
In what continues to be a busy news week for French drug major Sanofi-Aventis, and another patent victory for Big Pharma, the US Patent and Trade Mark Office has denied a request by Canada-based generic drugmaker Apotex for a second re-examination of the US patent for the firm's blockbuster blood thinner Plavix (clopidogrel), which is co-marketed with Bristol-Myers Squibb, and generated sales of $9.1 billion last year, $5.6 billion in the USA. 1 July 2010
article
Futura Medical, a UK developer of innovative products for consumer health care, has signed a development agreement with UK drug giant GlaxoSmithKline for the development of TPR100, the company's novel, topically applied product for pain relief. 1 July 2010
Generics
Anglo-Swedish drug major AstraZeneca announced last night that US District Court, District of Delaware, Judge Joseph Farnan has found that the substance patent protecting its blockbuster cholesterol lowerer Crestor (rosuvastatin) (RE37,314 ' the '314 patent) is valid and enforceable. In its ruling, the court found that no inequitable conduct was committed by any Shionogi employee. The court also held the '314 patent to be non-obvious and properly reissued. 30 June 2010
Pharmaceutical
A meta-analysis of previously published studies finds no evidence that statins are associated with a reduced risk of death among individuals at risk for but with no history of cardiovascular disease, according to a report in the June 28 issue of Archives of Internal Medicine, one of the Journal of the American Medical Association (JAMA)/Archives journals. 30 June 2010
Pharmaceutical
A series of new reports from the USA-based Consumer Reports Best Buy Drugs (BBD) caution that the benefits of statin use by children and some women may not outweigh the risks. Drugs to lower cholesterol - including statins - are the most commonly prescribed drugs in the USA, where they garnered more than $14 billion in sales last year. 30 June 2010
Pharmaceutical
The European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) announced, along with a string of positive recommendations for new drugs published in The Pharma Letter yesterday, that it has begun looking at the possible risk of cancer in patients taking angiotensin II receptor blockers (ARBs), a class of drugs which generated $25 billion of sales last year. 29 June 2010
Pharmaceutical
US drug major Eli Lilly has signed a development and exclusive license agreement for Marcadia Biotech's short-acting glucagon program, covering glucagon analogs that may provide greater convenience and ease-of-use than the current recombinant glucagon for the treatment of severe hypoglycemia. The program includes MAR531, a glucagon analog that is in preclinical development at Marcadia, as well as related backup compounds. 29 June 2010
Generics
of its June 21-24 meetings, which included several positive opinions to recommend backing approval of new drugs, as well extensions of indications and generic copies. 28 June 2010
Pharmaceutical
Two developers of RNA-based therapeutics, Denmark-headquartered Santaris Pharma A/S and the USA's miRagen Therapeutics, have formed a strategic alliance to develop microRNA-targeted medicines for the treatment of cardiovascular disease. 24 June 2010
Pharmaceutical
US drug major Eli Lilly and partner Kowa Pharmaceuticals America (a subsidiary of Japan's Kowa) have this week launched their new cholesterol lowerer Livalo (pitavastatin) through retail pharmacists in the USA. 23 June 2010
Pharmaceutical
In a further move of its declared intention to expand its consumer health care business, French drug major Sanofi-Aventis has entered into a definitive agreement under which its Canadian affiliate will acquire the assets of Canderm Pharma, a privately-held leading Canadian skin care company. This deal follows on the heels of the group's $1.9 billion acquisition of the North American CHC company Chattem (The Pharma Letter December 22, 2009). Financial of the Canderm buy were not disclosed. 16 June 2010
Pharmaceutical
A meta-analysis, published today in The Lancet Oncology by Ilki Sipahi from The University Hospitals Case Medical Center in Cleveland and colleagues, raises drug safety questions for practitioners and the regulatory community about the use of popular antihypertensive drugs. Are angiotensin-receptor blockers (ARBs) associated with increased risk of incident malignancies? Should we be concerned about all ARBs or a single drug, telmisartan? the authors ask. 14 June 2010
Pharmaceutical
US drug majors Pfizer and Bristol-Myers Squibb saw their share prices rise on Friday after announcing that they have agreed to stop the Phase III AVERROES clinical trial of apixaban in patients with atrial fibrillation. 14 June 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
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