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Generics
In another move by a pharmaceutical major to prop up falling revenues from original drugs in developed markets, Anglo-Swedish drugmaker AstraZeneca has reached an accord with Hyderabad, India-headquartered Aurobindo Pharma to supply finished dosage and sterile products for sale in emerging markets. Financial terms of the deal were not disclosed. 6 September 2010
Pharmaceutical
Presentations as the European Cardiology Society meeting taking place in Stockholm, Sweden, showed encouraging late-stage results for two drug candidates that could replace warfarin and aspirin in the prevention of blood clots and stroke and vie for a stake in a global market sector estimated to be worth around $20 billion a year. 1 September 2010
Pharmaceutical
Independent German drug major Boehringer Ingelheim says that the US Food and Drug Administration has granted a priority review designation for its novel oral direct thrombin inhibitor dabigatran etexilate for the prevention of stroke in atrial fibrillation (AF) patients. An FDA advisory committee will meet on September 20 to review and discuss dabigatran etexilate data. 1 September 2010
Generics
On August 27, 2010 the Brazilian Patent and Trademark Office (INPI) made public on its web site (www.inpi.gov.br/noticias) the decision rendered by the 1st Specialized Section of the Federal Court of Appeal of the 2nd Region on which the INPI's arguments were taken into consideration and the patent extension for US drugs behemoth Pfizer's (NSYE; PFE) blockbuster cholesterol lowerer Lipitor (atorvastatin was reduced. 1 September 2010
Pharmaceutical
The European Society of Cardiology (ESC) meeting, taking place in Stockholm, Sweden, saw presentation on: Anglo-Swedish drug major AstraZeneca's antiplatelet drug candidate Brilinta (ticagrelor); Servier's Procoralan; and the release of guidelines for the treatment of atrial fibrillation noting use of Sanofi-Aventis' Multaq (dronedarone). 31 August 2010
Biotechnology
Netherlands-based biotechnology company Pharming Group NV (NYSE Euronext: PHARM) says that it intends to submit the Biologic License Application the US Food and Drug Administration to obtain marketing approval for Rhucin (recombinant human C1 esterase inhibitor) for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). Following pre-BLA discussions with the FDA, Pharming says it is preparing the BLA dossier for submission towards the end of this year but no later than January 2011. 31 August 2010
Pharmaceutical
Ireland-based drugmaker Shire (LSE: SHP) says that the European Commission has granted marketing authorization for Vpriv (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease. VPRIV has been authorized as an orphan medicine through the Centralised Procedure, making it available in 30 countries across Europe. 27 August 2010
Pharmaceutical
In what has been a busy week for the agency, draft guidance published yesterday (26 August), by the UK National Health Service watchdog the Institute for Health and Clinical Excellence (NICE) has recommended two treatments for multiple myeloma and reversed an earlier negative decision on .on an atrial fibrillation product. 27 August 2010
Pharmaceutical
Having displayed fluctuating growth rates in the years 2005-2009 the Hungary pharmaceuticals market is expected to stabilize and perform low growth rates over the years up to 2014, according to a new report from Venn Research. 25 August 2010
Generics
US pharma giant Merck & Co (MRK: NY) Friday sued Impax Laboratories (Nasdaq: IPXL) in the federal court in New Jersey in order to prevent the company from selling a generic version of its cholesterol-lowering drug Vytorin (ezetimibe/simvastatin), before the expiry of the patent which is due in 2017. This action formally initiates the patent challenge process under the Hatch-Waxman Act. 24 August 2010
Pharmaceutical
In what can come as no surprise after the US Food and Drug Administration threatened to withdraw market approval of Ireland-based drugmaker Shire's low blood pressure therapy ProAmatine (midodrine; The Pharma Letter August 17), the company has said it will take the product off the US market, effective September 30. 19 August 2010
Pharmaceutical
The US Food and Drug Administration yesterday proposed withdrawing approval of midodrine, a drug used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been carried out. 17 August 2010
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) is currently reviewing its guidance on the use of the blood thinning drugs clopidogrel (French drug major Sanofi-Aventis' blockbuster drug Plavix) and modified-release dipyridamole (Persantin Retard and Asasantin Retard [combined with aspirin] from Germany's Boehringer Ingelheim) for the prevention of occlusive vascular events (OVEs), originally published in 2005. 6 August 2010
Biotechnology
US biotechnology firms Genentech (subsidiary of Swiss drug major Roche) and Seattle Genetics have expanded their antibody-drug conjugate collaboration agreement. Under the expanded agreement, Genentech will pay an upfront fee of $12 million for gaining rights to utilize Seattle Genetics' ADC technology with additional antigens. 5 August 2010
Pharmaceutical
Researchers in Germany and the USA have discovered a new signaling pathway of brain cells that explains how widely used antihypertensive drugs could keep inflammation in multiple sclerosis (MS) in check, according to a joint press release from Heidelberg University Hospital and the German Cancer Research Center (DKFZ). 30 July 2010
Pharmaceutical
The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee has recommended the approval of Anglo-Swedish drug major AstraZeneca's investigational drug ticagrelor - provisional trade name Brilinta - for the reduction of thrombotic events in patients with acute coronary syndromes (ACS, or blocked arteries), the company revealed last night. 29 July 2010
Pharmaceutical
Anglo-Swedish drug major AstraZeneca has filed a Para IV patent infringement law suit against the Gujarat-based Torrent Pharmaceuticals and its US subsidiary for its alleged move to manufacture and sell a generic version of its blockbuster cholesterol-lowering drug Crestor (rosuvastatin), before its patent expiry. 29 July 2010
Pharmaceutical
The US Food and Drug Administration yesterday approved Japanese drug major Daiichi Sankyo's Tribenzor (olmesartan medoxomil, amlodipine and hydrochlorothiazide), a new three-in-one combination product taken once-daily for the treatment of hypertension in patients who are not adequately controlled on any two of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers and diuretics. The new drug is not indicated for initial therapy. 27 July 2010
Pharmaceutical
French companies Cerenis Therapeutics, which is developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and other metabolic diseases, and Groupe Novasep, a supplier of manufacturing solutions to the life sciences industries, have received government funding of 10.7 million euros ($13.7 million) through France's innovation agency (OSEO) to finance the development of CER-001, a Cerenis HDL mimetic. The OSEO operates under the authority of the Ministry of Economy, Finance and Employment, and the Ministry for Higher Education and Research. 27 July 2010
Generics
The US Food and Drug Administration delivered a blow to Sanofi-Aventis on Friday, when it approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), a drug that had generated revenues of around $4.57 billion in (according to IMS Health) for the French drug major last year. 26 July 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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