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Pharmaceutical
According to the Association of Innovative Pharmaceutical Manufacturers (AIPM), to ensure that Hungarian patients can access the newest medicinal products, the level of public spending on medicines should be raised at least to the average of the Visegrad countries. 11 March 2019
Pharmaceutical
The flurry of pharma/biotech M&A deals since the start of 2019 continues into March, with Biogen announcing its $877 million deal to acquire Nightstar Therapeutics. The decision last week of US Food and Drug Administration Commissioner Scott Gottlieb – seen as one of the most proactive heads of the FDA - to quit the post after just two years came as something of a surprise. Significant regulatory news last week included FDA approval for Johnson & Johnson subsidiary Janssen’s ketamine-based antidepressant Spravato. On the research front, Allergan’s hopes for its depression candidate rapastinel suffered a setback in the latest trial data revealed on Wednesday. 10 March 2019
Pharmaceutical
US President Donald Trump recently promised a cheering Miami crowd that America "will never be a socialist country." Let's hope!, writes Institute for Policy Innovation (IPI) resident scholar Dr Merrill Mathews. 9 March 2019
Pharmaceutical
In a blog post, US industry lobbyist the Pharmaceutical Research and Manufacturers of America (PhRMA) has drawn attention to a recent analysis which compares the impact of the switch from Average Wholesale Price (AWP) for Part B medicines to the Average Sales Price (ASP) system. 8 March 2019
Generics
Research shows some 79% of the American public view the cost of prescription drugs as unreasonable, and lawmakers and regulators are increasingly convinced the industry charges too much for its products. 8 March 2019
Pharmaceutical
In a surprise announcement on Tuesday, it was revealed the US Food and Drug Administration Commissioner Scott Gottlieb would be stepping down from the post, in one month. 6 March 2019
Biotechnology
Senators in the US Congress have written to the US Food and Drug Administration seeking changes to official guidance, with the aim of expediting the release of new biosimilar insulin products. 5 March 2019
Pharmaceutical
The leading trade group for the Hungarian pharmaceutical industry has called on Hungary’s government to help prevent a decline in novel research taking place in the country. 4 March 2019
Pharmaceutical
The Irish Pharmaceutical Healthcare Association (IPHA) has defended the industry against a charge of ‘predatory’ pricing by the National Centre for Pharmoeconomics (NCPE). 4 March 2019
Pharmaceutical
The growth of the Russian pharmaceutical market has almost come to a halt in recent years, which is mainly as a result of falling incomes of the local population, freezing of state budgets for public procurements and tightened governmental control over the prices for vital drugs in Russia, according to recent statements of some leading Russian drugmakers and officials of the Russian Ministry of Health, reports The Pharma Letter’s local correspondent. 27 February 2019
Biotechnology
Lawmakers in the USA are pushing ahead with rules that would make it easier for parents to avoid vaccinating their children, even as health agencies report a rise in preventable diseases such as measles. 27 February 2019
Pharmaceutical
In Washington DC on Tuesday, the chief executives of half a dozen leading drugmakers defended the industry’s drug pricing rationale and shifted the blame for high prices onto the sector’s intermediaries. 27 February 2019
Pharmaceutical
China will cut import value-added tax (VAT) from 16% to 3% on the first batch of rare disease drugs from March 1, according to the new policy of China’s National Medical Products Administration (NMPA), formerly known as CFDA, reports The Pharma Letter’s local correspondent, Wang Fangqing. 26 February 2019
Pharmaceutical
Last week’s important research news included positive trial results from Pfizer and Eli Lilly with their tanezumab in chronic low back pain, and from Intercept Pharma for its non-alcoholic steatohepatitis (NASH) candidate Ocaliva. On the deal-making front, attracting attention was Johnson & Johnson unit Janssen’s agreement to access Morphic Therapeutics’ expertise on integrin therapeutics. Meantime, the US Food and Drug Administration and its technology unit went on the defensive regarding the quality of generic medicines coming to market. 24 February 2019
Generics
At the US Food and Drug Administration, “protecting patient and consumer health is our highest priority,” according to a statement issued on Friday by FDA Commissioner Dr Scott Gottlieb and director of the FDA’s Center for Drug Evaluation and Research, Dr Janet Woodcock. 23 February 2019
Biosimilars
A woman who has been involved in biosimilars since work on their development first began two decades ago, has been named director general of the International Generic and Biosimilar medicines Association (IGBA). 21 February 2019
Pharmaceutical
Australian Minister of Health Greg Hunt today announced that the government is providing more than A$22 million ($15.7 million) for important early-stage research that will lead to new interventions, cures and treatments of major diseases. 18 February 2019
Pharmaceutical
Issues such as immigration, housing and energy are likely to dominate much of the popular debate around the 2019 Australian federal elections. 15 February 2019
Biotechnology
The USA lobby group Biotechnology Innovation Organization (BIO) released a new report, “Science or Compliance: Will Section 404(b) Compliance Impede Innovation by Emerging Growth Companies in the Biotech Industry?” on Monday, coinciding with National Inventor’s Day. 12 February 2019
Pharmaceutical
US lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) on Friday urged the Office of the United States Trade Representative (USTR) to take immediate action to address serious and growing market access and intellectual property barriers in top overseas markets. 9 February 2019
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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