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Pharmaceutical
Japanese drug major Daiichi Sankyo (TYO: 4568) has announced data from the PRASFIT-ACS study, a double-blind randomized Phase III trial comparing efficacy and safety of prasugrel plus aspirin to clopidogrel plus aspirin in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). 25 September 2012
Pharmaceutical
Among a batch of recommendations resulting in meetings last week from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) was one for US drug major Eli Lilly's (NYSE: LLY) erectile dysfunction drug Cialis (tadalafil), for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in the European Union. 24 September 2012
Generics
US generic drugmaker Mylan (Nasdaq: MYL) last Friday received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for valsartan and hydrochlorothiazide tablets USP, 80/12.5mg, 160/12.5mg, 160/25 mg, 320/12.5mg and 320/25mg, a generic version of Swiss drug major Novartis' (NOVN: VX)blockbuster blood pressure drug Diovan HCT. 23 September 2012
Biotechnology
The discontinuation of Swiss drug major Roche (ROG: SIX) and Japan Tobacco's dalcetrapib earlier this year (The Pharma Letter May 8) leaves US pharma giant Merck & Co's (NYSE: MRK) anacetrapib as the front-runner in the novel CETP inhibitor drug class in the dyslipidemia drug market, according to a new report from health care advisory firm Decision Resources. 20 September 2012
Pharmaceutical
USA-based Unigene Laboratories Laboratories (OTCBB: UGNE) and Tarix Pharmaceuticals yesterday announced the successful completion of a feasibility study of an oral formulation of TXA127, Tarix' lead peptide drug candidate. 20 September 2012
Pharmaceutical
This year's European Society of Cardiology (ESC) Congress in Munich, Germany, was a stark example of exactly where the cardiovascular market space is headed, note analysts at industry expert GlobalData. This congress fully emphasized the new and innovative technologies that are coming out on the medical device and medical technology side, while leaving the market's pharmaceutical wing in the dust, they say. 17 September 2012
Biotechnology
The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) last week recommended against the approval of Cornerstone Therapeutics' (Nasdaq: CRTX) New Drug Application for lixivaptan (CRTX 080) for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. 17 September 2012
Biotechnology
The overall global market for translational regenerative medicine will reach a value of $1.4 billion in 2012. That revenue forecast and others appear in Translational Regenerative Medicine Market Prospects 2012-2022, published by Visiongain, a business information provider based in the UK. 12 September 2012
Pharmaceutical
Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development, German drug major Bayer's (BAYN: DE) partner for Xarelto (rivaroxaban) in the USA, last Friday submitted the Complete Response to the US Food and Drug Administration for the use of Xarelto to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS). 10 September 2012
Biotechnology
The European Medicines Agency has begun its first public consultation on its inventory of medicines for use by children. This inventory, which is being developed by the Agency's Pediatric Committee (PDCO), sets out areas where further research and development into medicines for children are needed. 2 September 2012
Generics
The UK subsidiary of Israel's Teva Pharmaceutical Industries (NYSE: TEVA), the world's largest generic drugmaker, yesterday announced the launch of generic Irbesartan tablets in the UK. Irbesartan is a generic version of Aprovel from France's Sanofi (Euronext: SAN) and USA-based Bristol-Myers Squibb (NYSE: BMY). 30 August 2012
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) said yesterday that ticagrelor, its oral antiplatelet medicine, marketed by the company as Brilique in the European Union and Brilinta elsewhere, received a Class I recommendation from the European Society of Cardiology (ESC) in the revised Guidelines on the Management of Acute Myocardial Infarction in Patients Presenting with Persistent ST-Segment Elevation (STEMI). 30 August 2012
Pharmaceutical
US drugs giant Merck & Co (NYSE: MRK) says that, following a review of the clinical trial data and discussions with external experts, it now plans to file marketing applications for its investigational anti-thrombotic drug vorapaxar in the USA and the European Union in 2013. 28 August 2012
Pharmaceutical
A major subgroup analysis from the ATLAS ACS 2-TIMI 51 study of 7,817 patients with acute coronary syndrome (ACS) and a recent ST-segment elevation myocardial infarction (STEMI) demonstrated that German drug major Bayer's (BAYN: DE) oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice daily, when added to standard antiplatelet therapy, provides a significant mortality benefit. The drug is under development with US partner Johnson & Johnson (NYSE: JNJ). 27 August 2012
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) issued draft guidance on Friday updating its previous recommendations on the use of Actilyse (alteplase) from German family-owned drug major Boehringer Ingelheim for the treatment of acute ischemic stroke. 27 August 2012
Pharmaceutical
The 12-month post-hospital acute coronary syndrome market will initially contract from just under $2 billion in 2011 to around $1.6 billion in 2013, mainly as a result of the US genericization of clopidogrel (Bristol-Myers Squibb/Sanofi's Plavix/Iscover, generics) in 2012, according to Decision Resources. 27 August 2012
Pharmaceutical
Indirect comparison based on the RE-LYtrial (for family owned German drugmaker Boehringer Ingelheim's Pradaxa; dabigatran etexilate) and the Rocket AF trial (for German major Bayer's [BAYN: DE] Xarelto; rivaroxaban) suggests advantages of Pradaxa in stroke prevention in patients with atrial fibrillation, according to a Boehringer press statement. 27 August 2012
Pharmaceutical
The TRILOGY ACS study, the first trial to study patients with acute coronary syndrome who do not undergo coronary stenting or bypass surgery found no significant difference between two currently marketed anti-clotting drugs - Japan's Daiichi Sankyo (TYO: 4565) and US partner Eli Lilly's (NYSE: LLY) Effient (prasugrel) and clopidogrel, Sanofi (Euronext: SAN) and Bristol-Myers Squibb's (NYSE: BMY) once blockbuster brand Plavix - in preventing the first occurrence of death, heart attack or stroke, according to Duke University Medical Center cardiologists. 27 August 2012
Generics
Wockhardt generic versions of Pfizer's Geodon and AstraZeneca's Plendil OKed by FDA 23 August 2012
Biotechnology
Anglo-Swedish drug major AstraZeneca (LSE: AZN) and US biotech firm Regulus Therapeutics have signed a strategic alliance for the discovery, development and commercialization of microRNA therapeutics for three exclusive targets which are currently in pre-clinical development. 16 August 2012
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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