Government Affairs
Refine Search
Pharmaceutical
The Australian government has said that its establishment of an expert panel for the Life Saving Drugs Program (LSDP) will improve the scheme’s ability to provide free medicines for rare and life-threatening diseases to those who need them. 31 August 2018
Biotechnology
The US Food and Drug Administration (FDA) has granted priority review to Alexion's ALXN1210, a long-acting C5 complement inhibitor, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 21 August 2018
Pharmaceutical
Perhaps not surprisingly, the HHS report starts with a comment congratulating the President and the plan, with the department’s Secretary Alex Azar quoted as saying: “The President’s blueprint for lower drug prices is working, drug prices are coming down, and American patients are going to see the savings in their pocketbook.” 21 August 2018
Biotechnology
Takeda's first-in-class allogneic stem cell therapy for the treatment of perianal fistulas in patients suffering from Crohn's Disease has been snubbed in a recommendation of the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales. 20 August 2018
Biotechnology
Vertex Pharmaceuticals' Orkambi (lumacaftor/ivacaftor) is set to be reimbursed on Australia's Pharmaceutical Benefits Scheme after it was cleared by a cost-effectiveness watchdog. 20 August 2018
Pharmaceutical
The USA’s Drug Enforcement Administration (DEA) and Department of Justice (DoJ) on Thursday moved to curtail drugmaker production of the most commonly abused prescription opioids, saying the cut will inhibit illicit sales of narcotic painkillers. 17 August 2018
Pharmaceutical
Anglo-American antibiotics developer Summit Therapeutics opened up more than 10% on Thursday following news that it is to receive further US government funding for its C difficile infection (CDI) drug candidate. 16 August 2018
Biosimilars
The world’s total expenditure on medicines was $1.135 trillion in 2017 and is projected to reach $1.4 trillion in 2022.1 Understandably, when contemplating such large figures, the reaction from governments, healthcare payers and the public has been to seek more value for every dollar spent, writes Dr Nicola Davies on her regular blog for The Pharma Letter. 13 August 2018
Pharmaceutical
Deal-making news last week that attracted attention included Neuren Pharma’s licensing agreement for its rare disease drug trofinetide with Acadia, which disappointed investors, and Sarepta Therapeutics gaining three gene therapies from Lacerta. Regulatory news included a disappointment for Pain Therapeutics as it revealed receipt of a Complete Response Letter from the US Food and Drug Administration relating to its New Drug Application for analgesic Remoxy, but on the positive front, the FDA approved Alnylam’s rare disease drug Onpattro, though analysts see competition in sight. Elsewhere, Novo Nordisk’s financial results showed disappointing figures for its diabetes drug Victoza, Also, there were new proposals from US health regulators to help Medicare negotiate lower drug prices. 12 August 2018
Biotechnology
An investigation by The Times of London has led to the UK's National Health Service (NHS) scrapping its restrictions on the use of Imbruvica (ibrutinib). 10 August 2018
Pharmaceutical
Leading domestic drugmakers in Russia have called on the national government to introduce additional restrictions on the participation of foreign companies in public procurements in the country, reports The Pharma Letter’s Russia correspondent. 10 August 2018
Pharmaceutical
Yesterday, delivering on proposals in President Trump’s American Patients First blueprint, the USA’s Health and Human Services (HHS) Department announced that Medicare Advantage plans will be able to use tools employed by private-sector insurers to negotiate lower prescription drug prices for patients. 8 August 2018
Biosimilars
The UK's Department for Health has launched a consultation on its plans to begin applying price controls to biosimilars, proposals that have promptly been ridiculed. 7 August 2018
article
No need for anxiety — that’s the line at the launch of a new white paper from contract research organization IQVIA, tackling the uncertainty facing UK biopharma ahead of the country’s departure from the European Union. 7 August 2018
Pharmaceutical
Sanofi and Novartis have announced that they are forming plans to stockpile months' worth of drugs in UK facilities ahead of the country's uncertain departure from the European Union in March 2019. 2 August 2018
Pharmaceutical
Well-publicized cases involving children needing cannabis-based treatments to reduce their suffering have led the UK to change its stance on these medicines for patients with an exceptional clinical need. 30 July 2018
Pharmaceutical
Indianan firm Eli Lilly has expressed concerns over US Health Secretary Alex Azar’s proposal to import drugs from overseas to prevent price hikes on products with limited competition. 25 July 2018
Biotechnology
More than two years since the National Institute for Care Excellence (NICE) ruled that Vertex Pharmaceuticals' cystic fibrosis therapy Orkambi (lumacaftor/ivacaftor) was too expensive to be issued through the National Health Service (NHS), the US firm has hit out at Parliament and NHS executives over delays. 25 July 2018
Pharmaceutical
Despite UK parliamentarians voting 305-301 in favor of continued involvement with the European Medicines Agency (EMA), medicines regulators across Europe are stepping up efforts in preparation for a possible ‘no-deal’ Brexit. 23 July 2018
Biotechnology
Changsheng Biotechnology is the subject of an ongoing controversy this week, after an inspection in mid-July found the company had fabricated production and inspection documents related to the production of 250,000 faulty rabies vaccines. 23 July 2018
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze