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Pharmaceutical
Following rumors reported yesterday as a result of a Wall Street Journal article, Anglo-Swedish drug major AstraZeneca late on Tuesday confirmed that the company has finalised a previously announced agreement in principle with federal and state entities in the USA to resolve civil allegations relating to the company's past marketing and promotion of its atypical antipsychotic, Seroquel (quetiapine). 28 April 2010
Pharmaceutical
A year-long evaluation process designed to assess the effectiveness and efficiency of the European Medicines Agency's (EMEA) operations has concluded with a largely favorable outcome for the Agency and its partner organizations in the European Union member states. 27 April 2010
Generics
By opening the door to competition from generic drugmakers, Ecuador is making a critical HIV/AIDS drug much more affordable for that country's public treatment programs - a move that other countries should follow, the US consumer watchdog Public Citizen has declared. 26 April 2010
Generics
In a final ruling from the European Court of Justice yesterday in the case of the Association of the British Pharmaceutical Industry (ABPI) versus the UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), the court ruled that public authorities can offer financial incentives to induce doctors to prescribe cheaper medicinal products. 23 April 2010
Pharmaceutical
Draft guidance that would expand transparency and disclosure when the US Food and Drug Administration grants a conflict of interest waiver to permit an individual's participation at an FDA advisory committee meeting was revealed yesterday in an agency web site posting. 22 April 2010
Pharmaceutical
The US Agency for Healthcare Research and Quality (AHRQ) last week directed $29.5 million in economic stimulus funds to 9,000 programs nationwide that aim to put straightforward, unbiased information about the wide range of available prescription drug treatments - known as 'comparative effectiveness research' - into the hands of America's physicians and their patients. 21 April 2010
Pharmaceutical
Five officials from China's State Food and Drug Administration (SFDA) have been arrested on charges of taking bribes, only three years after its former head was executed for the same offence, reported the Shanghai Daily. Another official was ordered by investigators to stay at home pending results of the investigation. 20 April 2010
Pharmaceutical
In a submission to an Australian Senate Inquiry which was released this week, the pharmaceutical trade group Medicines Australia has called on the government to think carefully about how it manages the Pharmaceutical Benefits Scheme. 16 April 2010
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published the results of its product verification system pilot project to prevent counterfeiting of medicines. The pilot, held in Sweden between September 2009 and January 2010, successfully demonstrated that a product verification system at the point of dispense, based on a two-dimensional data matrix, is both robust and effective. 15 April 2010
Biotechnology
The US Food and Drug Administration held a public meeting on April 12, to discuss the reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA IV, currently set to expire in September 2012, authorizes the FDA to collect user fees from companies wishing to submit their products for agency review. The intention is that the fees would be used to provide an additional revenue stream for the agency to hire more staff, improve systems and establish a better managed drug review process to speed up the delivery of needed therapies to the public. 15 April 2010
Biotechnology
The Next Generation Pharmaceutical (NGP) Union, held in the Netherlands last week, saw over 50 drug industry leaders gathered for the Supreme Court verdict against Myriad Genetics given on March 29, which voted against the company's patent claims and, as a result, a storm is brewing in the biotechnology community. 15 April 2010
Biotechnology
Politics and legal rulings have major influences on how the biotechnology sector performs. If you consider politics, at times it can have a restrictive influence, similar to when the USA's Bush Administration imposed a ban on government funding for human embryo research, notes new research from South Africa-based Rothman Research. 15 April 2010
Pharmaceutical
Almost two-thirds of general practitioners in the UK are against the abolition of prescription charges for all patients under the National Health Service, a GP newspaper survey has found. However, leaders of the British Medical Association (BMA) have repeatedly called for prescription charges to be abolished across the UK. 14 April 2010
Generics
April 12, 2010
After three days of talks last week, officials from India and Japan have resolved several stumbling blocks to their proposed free trade agreement (FTA) - opening up sectors like pharmaceuticals and services ' and thus raising prospects for its signing during the current year. 12 April 2010
Generics
The Canadian Province of Ontario plans to further reform the prescription drug system to provide better access to lower-cost generic drugs for patients, while continuing to increase annual funding to the drug system as a whole. 9 April 2010
Biotechnology
US biotechnology firm Genzyme has welcomed the decision by the All Wales Medicines Strategy Group (AWMSG) to recommend its Mozobil (plerixafor) for use within the National Health Service in Wales. 9 April 2010
Biotechnology
The long-running trade dispute relating to subsidies for cotton growers between the USA and Brazil reached an agreement yesterday, just a day before the latter country was due to start imposing sanctions on American products of up to $830 million authorized by the World Trade Organization, which had rules that the subsidies violated global trade laws. 8 April 2010
Pharmaceutical
The UK Department of Health says it has reached an accord with drugs giant GlaxoSmithKline on outstanding orders of swine flu vaccine resulting in significant savings for the government, claiming it represented fair value for both parties and means savings of around a third of the original value of the total orders with GSK, although actual financial amounts were not revealed. 7 April 2010
Biotechnology
Following yesterday's announcement by UK Prime Minister Gordon Brown that a general election will - as had been widely expected - definitely take place on May 6, the country's biotechnology trade group, the BioIndustry Association (BIA) highlighted to members the opportunity this presents to promote the life sciences agenda. 7 April 2010
Pharmaceutical
German Health Minister Philipp Roesler has now fleshed out the governing coalition's proposals to contain the cost of branded drugs in Germany (The Pharma Letter March 22) ' and the pharmaceutical industry lobby has 'reacted with fury,' reports the Financial Times Deutschland. Cornelia Yzer, general manager of the trade group VFA, has accused him of plunging the industry into 'crisis.' 6 April 2010
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
article
The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Pharmaceutical
The Danish government’s newly-unveiled health reform has been praised for tackling chronic disease care and health inequalities while driving health innovation. 18 November 2024
Pharmaceutical
New research published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) provides in-depth analysis of the economic footprint of the pharmaceutical industry in Europe, across member states and compares Europe to other regions of the world. 18 November 2024
Pharmaceutical
Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024
Pharmaceutical
The share prices of Pfizer, GSK, Novavax and other vaccine companies were all markedly lower on Friday. This was not due to the publication of disappointing research results in the sphere, or an ominous stance taken by a major regulator on a key filing, but rather a political development that could spell trouble for the vaccines field as a whole. 15 November 2024
Biotechnology
BeiGene has announced plans to rebrand as BeOne Medicines, a move the cancer specialist says reflects its commitment to fighting cancer through collaboration. 15 November 2024
Pharmaceutical
Danish patients are being offered fewer innovative treatments than Norwegians and Swedes, a new estimate from the Danish Medicines Council shows. 11 November 2024
Pharmaceutical
According to the Swedish pharma trade group Lif, it is positive that, in the updated life science strategy, the government expresses an ambition for Sweden to become more attractive for research investments. 11 November 2024
Pharmaceutical
Li Li, Commissioner of China's National Medical Products Administration (NMPA), and Mette Aaboe Hansen, interim director general of Danish Medicines Agency, have signed a letter of intent to promote bilateral cooperation in regulation of drugs and medical devices. 11 November 2024
Pharmaceutical
Following the news that Donald Trump is the winner of the 2024 US Presidential Election, Morningstar Equity analyst Julie Utterback has published a new note about the impact of this on the managed-care industry. 7 November 2024
Pharmaceutical
UK pharma major AstraZeneca, which has invested heavily in China, hosted a sell-side analyst call on Wednesday (November 6) to discuss the recent media reports about ongoing investigations in China. 7 November 2024
Pharmaceutical
Some of the UK’s leading academics and industry professionals have welcomed Chancellor Rachel Reeves’ £520 million ($669 million) pledge to develop the country’s medicine manufacturing capabilities. 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
The Danish government is rolling out the red carpet and welcomes several pharmaceutical companies. 4 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Pharmaceutical
Following the first Labour budget for 14 years, the Association of the British Pharmaceutical Industry (ABPI) welcomes Chancellor Rachel Reeves’ measures to improve UK life sciences competitiveness. 30 October 2024
Pharmaceutical
HOPO Therapeutics has been awarded a contract valued at up to $226 million from the Biomedical Advanced Research and Development Authority (BARDA). 29 October 2024
Pharmaceutical
The Danish government has presented part of the plan for a future life science strategy, which has been welcomed by the industry. 28 October 2024
Biotechnology
Legend Biotech has removed Genscript Biotech as its majority shareholder, in a move coinciding with rising US concerns over Chinese ties within the biotech sector. 24 October 2024
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