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Pharmaceutical
US trade group the Pharmaceutical Research and Manufacturers of America (PhRMA) has raised objections to a drug pricing plan outlined by House Speaker Nancy Pelosi. 11 October 2019
Pharmaceutical
Companies transporting medical products into or out of the UK are being advised to register for government-procured freight capacity in case there is a no-deal Brexit – even though the service will not be ready in time. 9 October 2019
Pharmaceutical
The Irish pharmaceutical industry has called for the European regulatory framework to be protected and strengthened for the biopharma sector. 7 October 2019
Pharmaceutical
The UK government has banned parallel exports of certain drugs amid fears that Brexit's potential impact on the pound could worsen current shortages. 4 October 2019
Pharmaceutical
As the incurable Duchenne muscular dystrophy (DMD), a rare genetic disease, takes a heavy toll of children in India, the Ministry of Health and Family Welfare has given instructions to speed up the process of formulating the National Policy for treatment of Rare Diseases, reports The Pharma Letter’s India correspondent. 1 October 2019
Pharmaceutical
The US National Institutes of Health (NIH) has awarded a grant of up to $4.6 million to Sydney University spinout Kinoxis Therapeutics, under an initiative aimed at combating the epidemic of opioid addiction in America. 30 September 2019
Pharmaceutical
Regulatory news last week included US Food and Drug Administration approval for Danish diabetes care giant Novo Nordisk’s Rybelsus the oral formulation of semaglutide. GlaxoSmithKline announced an additional investment of $120 million in its US manufacturing facilities. On the political front, the UK opposition Labour party announced its intention to set up a state-owned company to produce generics and also said it would use compulsory licensing if it wins the next election. In terms of research results, G1 Therapeutics’ mid-stage breast cancer drug trilaciclib has been attracting attention. 29 September 2019
Pharmaceutical
A report has been published on the progress made by the UK’s Department of Health and Social Care (DHSC) and partners to prepare supply lines ahead of the country leaving the European Union (EU). 27 September 2019
Pharmaceutical
Speaking at his party’s annual conference in Brighton, UK, Labour leader Jeremy Corbyn said he would legislate to create a state-run generic drugs firm, if elected. 25 September 2019
Pharmaceutical
The news last week that Denmark’s Lundbeck is to acquire Alder Biopharmaceuticals and its migraine prevention drug eptinezumab for as much as $1.95 billion has raised some questions. Regulatory news featured Aimmune gaining US Food and Drug Administration advisory panel support for its peanut allergy treatment Palforzia, and Janssen/Johnson & Johnson’s prostate cancer drug Erleada getting FDA approval. On the pricing front there was a new proposal from the US Democrats proposing negotiating Medicare prices for drugs that have no direct competition. 22 September 2019
Biotechnology
On Thursday, US House of Representatives Speaker Nancy Pelosi unveiled drastic proposals that would allow Medicare to negotiate lower prices on as many as 250 drugs and apply those discounts to private health plans. 19 September 2019
Pharmaceutical
The government in Greece has announced support for the pharmaceutical sector, indicating that companies will be able to offset a portion of R&D costs, including for clinical trials. 16 September 2019
Pharmaceutical
Following the publication of an internal UK government briefing on the likely impact of a no-deal Brexit, and plans to mitigate those effects, the British pharmaceutical industry has called for more practical details from the government on how plans will be implemented. 12 September 2019
Pharmaceutical
With the aim of curbing diversion and misuse, the US Drug Enforcement Administration (DEA) is proposing to reduce the amount of five Schedule II opioid controlled substances that can be manufactured in the United States next year compared with 2019, per the Notice of Proposed Rulemaking being published in the Federal Register and available for public inspection here. 12 September 2019
Pharmaceutical
Two months after the start of the first stage of labeling (labeling of drugs for high cost nosology), the Russian government approved a new cryptocode length. 11 September 2019
Biosimilars
Industry group the Alliance for Safe Biologic Medicines (ASBM) has voiced objections to a Canadian Province using biosimilar medicines to treat inflammatory bowel disease (IBD). 11 September 2019
Pharmaceutical
As incoming European Commission President Ursula von der Leyen prepares to take office at the end of next month, representatives from the pharmaceutical industry are stepping up lobbying efforts on behalf of the sector. 10 September 2019
Pharmaceutical
A highly-anticipated report from Public Health England (PHE) finds that up to a quarter of adults are being prescribed medication for pain, insomnia or depression. 10 September 2019
Pharmaceutical
The Russian government has decided to allocate additional funding for the purchases of some vital, imported drugs, which are not produced in the country, amid fears of their potential shortage in the local market, according to recent statements made by an official spokesman of the Russian Ministry of Health as well as some industry’s analysts, reports The Pharma Letter’s local correspondent. 10 September 2019
Pharmaceutical
The UK’s National Health Service (NHS) is to review making high-dose statins available direct from pharmacists as part of its Long Term Plan to cut heart disease. 4 September 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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