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The Indian subsidiary of Anglo-Swedish pharma major AstraZeneca has filed a writ petition before the Delhi High Court challenging a demand notice from India's National Pharmaceutical Pricing Authority (NPPA) alleging overcharging of Tagrisso (osimertinib) tablets by the company. 1 July 2021
Biotechnology
The Alzheimer’s community, together with the share price of USA-based developer Biogen (Nasdaq: BIIB), was given a considerable fillip at the start of June, with the approval of Aduhelm (aducanumab). 28 June 2021
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is not happy. 24 June 2021
Generics
Prices for imported pharmaceutical substances are steadily increasing in Russia, which creates serious problems for domestic drugmakers, whose costs have also grown significantly in recent months, according to a recent study, conducted by a local analytics company RNC Pharma, reports The Pharma Letter’s local correspondent. 22 June 2021
Biotechnology
Cambridge, UK-based drugmaker AstraZeneca has welcomed a ruling by the Court of First Instance, in Brussels, which appeared to vindicate the company’s approach to the distribution of its coronavirus vaccine. 18 June 2021
Pharmaceutical
The US government has announced it will invest more than $3 billion to boost discovery and development of new antiviral medicines for the novel coronavirus. 18 June 2021
Generics
In a move that will help ensure sub-standard or counterfeit drugs do not reach customers, India's Health Ministry is looking to make it mandatory for companies to include codes to track-and-trace key ingredients used to make medicines in India. 17 June 2021
Biotechnology
The US government has purchased an additional 200 million doses of the coronavirus vaccine developed by Moderna, in case boosters are needed. 17 June 2021
Biotechnology
Advanced therapy trade group The Alliance for Regenerative Medicine (ARM) has highlighted the passage of a new piece of legislation designed to accelerate patient access in Germany. 15 June 2021
Biotechnology
In the USA, Cambridge-based Moderna has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents. 11 June 2021
Biotechnology
The US government has committed to buying 500 million doses of Comirnaty, the vaccine provided by Pfizer and BioNTech, for lower-income countries. 10 June 2021
Pharmaceutical
The US government will procure around 1.7 million courses of an investigational antiviral treatment, molnupiravir (MK-4482), for COVID-19 from Merck & Co, pending emergency use authorization (EUA) or approval from the US Food and Drug Administration (FDA). 9 June 2021
Pharmaceutical
The White House, the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the US Food and Drug Administration have released a series of policy recommendations to address the vulnerabilities in U.S. pharmaceutical supply chains. Led by FDA and ASPR, the White House report - PDF and its recommendations have been accepted by President Joe Biden. 9 June 2021
Generics
The Indian government has offered 55 drugmakers $2.06 billion in production-linked incentives (PLI) for six years through fiscal year 2029 to boost manufacturing of medicines, in-vitro diagnostics and their raw materials. 8 June 2021
Pharmaceutical
Leading Russian pharmaceutical producers and foreign companies operating in the local market have called on the national government to increase the volume of support for companies that are involved in the development and launch of innovative drugs in the domestic market, The Pharma Letter’s local correspondent reports. 8 June 2021
Pharmaceutical
Since accelerating access to pharmaceutical innovation is also a strategic goal of the government, Hungary’s Association of Innovative Pharmaceutical Manufacturers (AIPM) trusts that, following the forced stagnation in 2020 caused by the epidemic, along with the restart of the economy, new modern drug therapies will soon also be available to Hungarian patients, and there will be more room for manoeuvre in next year’s budget for the inclusion of new medicinal products in social security subsidy. 1 June 2021
Generics
The United Arab Emirates (UAE) has sought Indian investment in the pharmaceutical sector. 27 May 2021
Pharmaceutical
AstraZeneca’s planned $39 billion buy of American rare disease specialist Alexion Pharmaceuticals hit a speed bump on Tuesday, after the UK’s antitrust body launched a review of the deal. 26 May 2021
Biotechnology
The European Commission (EC) should exempt advanced therapies from Genetically Modified Organism (GMO) legislation, which hurts Europe’s ability to attract clinical trials and delays patient access to transformative medicines. 26 May 2021
Pharmaceutical
New bipartisan legislation has been proposed by two US Representatives that would fund critical research on treatments and cures for diseases including Alzheimer’s, cancer, blindness, juvenile diabetes, and sickle-cell anemia amid research delays caused by the pandemic. 25 May 2021
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
Pharmaceutical
Trade group the Association of the British Pharmaceutical Industry (ABPI) has had its say on UK government plans to overhaul the National Health Service (NHS). 21 October 2024
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