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With the US Senate Committee on Appropriations beginning its markup and consideration of appropriations bills for Fiscal Year 2011, and in particular the Agriculture, Rural Development, FDA [Food and Drug Administration], and Related Agencies Appropriations bill (S 3606), rare and neglected disease (ie, orphan disease) advocates appear to be poised to make big gains (once again!), once again, comments Kurt Karst, writing on law firm Hyman, Phelps & McNamara's FDA Law Blog. 20 July 2010
Pharmaceutical
The Danish Medicines Agency (DMA) intends to develop an own guideline for active pharmaceutical ingredient (API) audit reports, which it says will provide guidance to finished medicinal product manufacturers for the documentation of the Good Manufacturing Practice (GMP) compliance of their API suppliers. This is the result of a survey conducted by the DMW last year concerning the GMP surveillance of pharmaceutical companies. 20 July 2010
Pharmaceutical
The US Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program (NTP) and the National Institute of Health Chemical Genomics Center (NCGC) welcome the Food and Drug Administration to the Tox21 collaboration. 20 July 2010
Pharmaceutical
During its recent general assembly, Spanish drugs trade group Farmaindustria's president and director general, Jesus Acebillo and Humberto Arnes, respectively, analysed the impacts that the Royal Decree-Laws 4/2010 of March 26 and 8/2010 of May 20 will have on the pharmaceutical industry. 19 July 2010
Pharmaceutical
A national approach to funding research and production of drugs for the treatment of rare diseases is needed for Canada, and the nation and can learn from other countries how to do this, say researchers in an analysis article published in the Canadian Medical Association Journal, July 12 issue. 14 July 2010
Generics
Last week saw the rector of Belgium's Katholieke Universiteit Leuven, Mark Waer, inaugurate the Chair of 'European policy towards generic medicines,' which is funded by the European Generic medicines Association (EGA) in collaboration with copy-drug majors Mylan, Ratiopharm, Sandoz and Teva Pharmaceuticals, for a five-year period. 14 July 2010
Pharmaceutical
UK Health Secretary Andrew Lansley yesterday launched a White Paper, titled 'Equity and Excellence: Liberating the NHS [National Health Service],' under which every general practitioner will have to join a commissioning consortium by 2011/12, essentially abolishing the Primary Care Trust and Strategic Health Authorities system in operation at present. 13 July 2010
Generics
Concerned about the negative image being projected elsewhere about the Indian pharmaceutical industry as a hub of spurious drugs, the Commerce Ministry wants to find a permanent solution to the issue by creating some system with the help of the industry or through the Directorate General of Foreign Trade (DGFT), reports the local news service PharmaBiz.com. 12 July 2010
Pharmaceutical
The pharmaceutical market the Ukraine is moving toward strong recovery in 2010, with Business Monitor International forecasting a 21.5% US dollar rebound to follow a 23.7% slide in a disastrous 2009 for Ukraine's economy. 7 July 2010
Generics
The number of patent settlements in the pharmaceutical sector that are potentially problematic under the European Union's antitrust rules fell to 10% of total patent settlements in the sector in the period July 2008 to December 2009 compared with 22% in the period covered in last year's inquiry into the pharmaceutical sector (January 2000-June 2008). 6 July 2010
Generics
Ahead of the July 4/5 Independence Day holiday weekend, the US House of Representatives passed a package of amendments to the War Funding Bill (HR 4899) that included the 'Preserve Access to Affordable Generics Act,' which is intended to curb pharmaceutical patent settlement agreements - so-called 'pay-for-delay' deals between research-based pharmaceutical companies and generic drugmakers. 5 July 2010
Pharmaceutical
Cutting pharmaceutical prices will severely reduce the number of new medications making it to market, according to a groundbreaking independent study from Berlin, Germany-based ESMT Competition Analysis (ESMT CA). 5 July 2010
Pharmaceutical
Noting that only about 200 of the nearly 7,000 diseases classified as rare currently have treatments, the National Organization for Rare Disorders (NORD) has called for a US Food and Drug Administration 'statement of policy' on regulation of therapies for rare disorders. 1 July 2010
Pharmaceutical
In a move that was largely expected Germany's Cabinet voted on legislation that would break the pharmaceutical companies' grip on prices with a bill aimed at saving the ailing health care system about 2 billion euros ($2.46 billion) a year. 30 June 2010
Pharmaceutical
US Senator Charles (Chuck) Grassley (Republican, Iowa) has released a staff report of the Committee on Finance on the practice of medical ghostwriting and is urging the National Institutes of Health to incorporate its findings in new, final disclosure guidelines. The committee staff report is based on a two-year review of the role that pharmaceutical and medical device companies play in developing articles for publication in medical journals. 29 June 2010
Pharmaceutical
At the end of a debate on the handling of the H1N1 pandemic, the Council of Europe Parliamentary Assembly (PACE) has endorsed the conclusions of its Health Committee, which were published last June, and deliberated at length ever since (The Pharma Letters passim). 28 June 2010
Pharmaceutical
Last week, Victoria Espinel, the US Barack Obama Administration's Intellectual Property Enforcement Coordinator (IPEC), released the "Joint Strategic Plan on Intellectual Property Enforcement" that Congress ordered when it created the IPEC position. The plan ' the results of a month-long public process - lays out 33 "enforcement action items" grouped in six categories. 28 June 2010
Pharmaceutical
Pharmacoeconomic methods rank low as a decision influencer on formulary changes, according to a new survey released this month by the US Society of Hospital Medicine (SHM) and the American Society of Health-System Pharmacists (ASHP). Respondents reported that only 13% of formulary system decisions made by Pharmacy and Therapeutics (P&T) committees in hospitals is influenced by pharmacoeconomic methods. 25 June 2010
Biotechnology
The harsh Budget announcement from the UK's coalition Conservative/Liberal Democrat government yesterday by Chancellor George Osborne, aimed at massive savings and some additional taxes to bring public finances under control, received mixed responses from the country's bioscience sector. 23 June 2010
Pharmaceutical
The long-running dispute between the USA and Brazil, which included imposing sanctions on US imports of pharmaceutical products, among total sanctions of $591 million (The Pharma Letter April 8), has moved a further step forward. 22 June 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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