Pricing, reimbursement and access
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Pharmaceutical
Norgine today presented new UK real-world data, IMPRESS, that show Xifaxan 550mg (rifaximin-α) for the treatment of hepatic encephalopathy could reduce costs related to non-elective hospital admissions, critical care bed occupancy, emergency room visits and 30-day emergency re-admissions. 31 October 2016
Pharmaceutical
The new pricing Agreement between the Irish Pharmaceutical Healthcare Association (IPHA) and the State which was finalized in July, is on course to save the State over 140 million euros ($154 million) in its first year. 24 October 2016
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance which Bristol–Myers Squibb’s Opdivo (nivolumab) should be made available to people who have been previously treated for advanced renal cell cancer (RCC) – a type of kidney cancer. 21 October 2016
Pharmaceutical
The European Court of Justice has issued a ruling that strikes against fixed prices for prescription drugs in Germany. The specific case dealt with mail-order prescriptions from the Netherlands used to treat Parkinson's, reports Deutsche Welle. 20 October 2016
Biotechnology
Celgene announced today that adult patients in England and Wales with chronic plaque psoriasis will now have access to oral Otezla (apremilast) following a positive final appraisal determination from the National Institute for Health and Care Excellence (NICE). 20 October 2016
Pharmaceutical
Amicus Therapeutics says that the National Institute for Health and Care Excellence (NICE) has issued draft ‘Highly Specialized Technologies’ guidance recommending its Galafold (migalastat) for the treatment of Fabry disease. 19 October 2016
Pharmaceutical
The Italian subsidiary of South Africa’s Aspen Pharmacare has challenged the findings of the Italian Competition Authority (ICA) of an alleged antitrust violation by Aspen and its related group companies. 19 October 2016
Pharmaceutical
The Italian Competition Authority (ICA) imposed a fine of more than 5 million euros ($5.5 million) on South Africa-based drugmaker Aspen Pharmacare for infringing article 102a of the Treaty on the Functioning of the European Union. 18 October 2016
Pharmaceutical
In our weekly expert view piece, Rohit Malpani, director of policy and analysis for Mèdecins Sans Frontiéres Access Campaign, discusses the UN Secretary General's High-Level Panel report on Access to Medicines and looks at the responsibilities it places on industry. 17 October 2016
Generics
Prices for cheap drugs from the list of vital medicines may significantly increase in Russia this year due to a recent decision by the Russian government to refrain from further state regulation of prices for drugs from this segment. 17 October 2016
Pharmaceutical
US pharma major Bristol-Myers Squibb saw its shares fall nearly 10% to $50.04 last Monday to a near two year low, on the news that its best-selling cancer immunotherapy drug Opdivo had failed to beat placebo in a head to head trial, the results of which were presented in Denmark over the weekend at the ESMO 2016 Congress. 15 October 2016
Pharmaceutical
Canada’s Valeant Pharmaceuticals International on Friday announced that the company's Patient Access and Pricing Committee has made decisions regarding price changes of products in the company's neurology, gastrointestinal (GI) and urology portfolios. 15 October 2016
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has proposed changes to the way it appraises new treatments that could see patients benefiting from the most cost effective treatments nearly three months faster than is currently the case. 14 October 2016
Biotechnology
The National Institute for Health and Care Excellence (NICE) has asked Bristol-Myers Squibb to set out a case for including its Opdivo (nivolumab) in the Cancer Drugs Fund (CDF). 14 October 2016
Biotechnology
In draft guidance published today, the medicines cost effectiveness watchdog for England and Wales says that it does not recommend Imbruvica (ibrutinib) for treating some people with Waldenstrom’s macroglobulinemia – a rare type of slow growing non-Hodgkin’s lymphoma. 12 October 2016
Pharmaceutical
Inpatient hospital drug costs increased more than 38% per admission between 2013 and 2015, according to a new report from the University of Chicago’s NORC, an independent research institution. 12 October 2016
Biotechnology
The medicines cost-effectiveness watchdog for England and Wales has today published draft updated guidance recommending National Health Service use of US biotech firm Celgene’s Otezla (apremilast) for psoriatic arthritis. 11 October 2016
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC has reached agreement with the local subsidiary of UK pharma major GlaxoSmithKline for the funding of the HIV treatments, dolutegravir (Tivicay) and abacavir sulphate with lamivudine (Kivexa). 11 October 2016
Pharmaceutical
On October 12, the European Parliament’s Environment, Public Health and Food Safety (ENVI) committee will consider the new draft report on medicines access. 10 October 2016
Generics
Mylan said on Friday that its subsidiary, Mylan Inc, has agreed to the terms of a $465 million settlement with the US Department of Justice and other government agencies. 8 October 2016
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 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
Biotechnology
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Pharmaceutical
The US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) today launched new advertisements urging Congress to make sure savings on medicines go to patients, not middlemen. 11 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
UK pharma major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2 polyneuropathy across England and Wales. 29 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Pharmaceutical
The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines for breast cancer, providing a boost to Novartis' Kisqali (ribociclib). 24 October 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved US pharma major Eli Lilly’s (NYSE: LLY) Kisunla (donanemab) for people in Britain with mild cognitive impairment or those in the early stages of Alzheimer’s disease. 23 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), yesterday released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. 23 October 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended elafibranor 80mg tablets for the treatment of PBC, the drug’s French developer Ipsen announced today. 22 October 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). 22 October 2024
Pharmaceutical
Pharmaceutical Research and Manufacturers of America (PhRMA) says it has submitted comments to the Office of the United States Trade Representative (USTR) to inform the agency’s 2025 National Trade Estimate (NTE) Report on Foreign Trade Barriers. 21 October 2024
Pharmaceutical
“The new key figures from the NZa show that Dutch expenditure on expensive medicines remains stable,” says Mark Kramer, chairman of the Association of Innovative Medicines (VIG), adding: “That is good news from a social perspective.” 21 October 2024
Pharmaceutical
The Danish Medicines Council (Medicinrådet), responsible for evaluating and recommending new treatments for Denmark’s healthcare system, is facing a significant increase in processing times. 14 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Biosimilars
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
Biotechnology
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
Pharmaceutical
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
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