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Pharmaceutical
Drug pricing policy changes in the USA were signed into law as part of the Inflation Reduction Act last month in one of the most impactful acts of the Biden administration so far. 21 September 2022
Biotechnology
German biotech Evotec has been awarded a contract valued at up to $49.9 million by the US Department of Defense (DOD) for the rapid development of monoclonal antibody (MAb)-based drug product prototypes targeting plague. 20 September 2022
Biosimilars
In an effort to bring clarity to the use of biosimilars in Europe, health authorities have issued a statement confirming their interchangeability with reference medicines. 20 September 2022
Pharmaceutical
US agencies the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND). 16 September 2022
Generics
As global pharma majors exit South America after the coronavirus pandemic, India's Pharmexcil (Pharmaceuticals Export Promotion Council of India) is looking to promote Indian pharmaceutical exports in the Latin American and Caribbean Region. 14 September 2022
Pharmaceutical
Sophisticated products in the form of biologics and large molecules, produced by living materials from humans, animals, plants, or microorganisms, are increasingly prevalent in today’s market. These types of drugs may include cell and gene therapy (CGT) products typically produced in low numbers. 13 September 2022
Pharmaceutical
American president Joe Biden has announced his intent to appoint Dr Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health (ARPA-H), a new agency established to drive biomedical innovation that supports the health of all Americans. 13 September 2022
Pharmaceutical
India's drug regulator has stepped up efforts to stop the sale of unapproved antibiotic cocktail combinations over the counter. The regulator has warned that certain fixed-dose combinations (FDCs) will be banned unless scientific trials are conducted to verify their regularisation before they can be distributed, reports The Pharma Letter’s India correspondent. 8 September 2022
Pharmaceutical
Johnson & Johnson and its USA-based Janssen Pharmaceutical Companies have announced a settlement agreement with the State of New Hampshire and its participating subdivisions resolving their opioid-related claims against the company. 2 September 2022
Pharmaceutical
The government of Russia has increased procurements of expensive drugs almost three-fold this year, mainly due the increase in the number of long-term agreements that are signed between the Russian state and drugmakers, reports The Pharma Letter’s local correspondent. 1 September 2022
Biotechnology
Arcturus Therapeutics, a global, late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, has announced that it has obtained an award for up to $63.2 million from the Biomedical Advanced Research and Development Authority (BARDA). 1 September 2022
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US biopharma Chimerix has signed a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA) for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of Tembexa (brincidofovir) to the US government. 30 August 2022
Generics
It was not so very long ago that Indian drugmakers were facing headwinds due to the spike in prices of active pharmaceutical ingredients (APIs) and intermediates being imported from China. From being dependent on China for APIs in the past, India has now swung to the opposite end of the spectrum and is imposing anti-dumping duties on several APIs and key starting materials that come from China, reports The Pharma Letter’s India correspondent. 30 August 2022
Pharmaceutical
The face of the USA’s response to the coronavirus pandemic, Anthony Fauci, has announced he will step down from his role as Director of the National Institute of Allergy and Infectious Diseases (NIAID). 23 August 2022
Generics
Russia plans to rebuild its pharmaceutical sector, which has been hit significantly by international sanctions and their consequences, that will be part of the recently announced state strategy of ensuring Russia’s national drug sovereignty by reducing the country’s dependence on the imports at all stages of drug production, from intermediates to the production of pharmaceutical substances. 23 August 2022
Pharmaceutical
Several multinational pharmaceutical companies and some domestic firms, as well as the trade group the Organization of Pharmaceutical Producers of India (OPPI), have expressed their opposition to the Indian government's plan to rationalize trade margins on novel or patentable medications which many drug firms tend to offer free to patients. 22 August 2022
Biotechnology
French speciality vaccines maker Valneva (Nasdaq: VALN) has announced that the US Department of Defense (DoD) has decided not to exercise the second option year of the contract to supply Valneva’s Japanese encephalitis (JE) vaccine Ixiaro. 22 August 2022
Pharmaceutical
The USA’s Inflation Reduction Act, which was signed into law Tuesday afternoon, contains several provisions that affect financial service company Morningstar’s stock valuations in the clean energy and pharmaceutical industries, according to Dave Sekera, chief US market strategist for Morningstar. 19 August 2022
Biotechnology
Two federal programs that have been driving innovation for 40 years by providing seed funding to entrepreneurs are in danger of running out of money - unless Congress acts by September 30, according to the USA’s Biotechnology Innovation Organization (BIO). 18 August 2022
Pharmaceutical
Medicines Australia's national medicines policy (NMP) review, which was put on hold before the May federal election, has restarted. 18 August 2022
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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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