Pricing, reimbursement and access
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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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Pharmaceutical
In evidence provided to the UK government’s Health and Social Care Committee, the British pharmaceutical industry will argue that NHS England and other public sector bodies must restart clinical trials and improve access to new treatments. 26 October 2021
Biotechnology
UK health technology assessor the National Institute for Heath and Care Excellence (NICE) has recommending the use of Givlaari (givosiran) on the NHS in England as an option for the treatment of acute hepatic porphyria (AHP) in people 12 years and older who have clinically confirmed severe recurrent attacks (four attacks or more within 12 months). 21 October 2021
Biosimilars
Semglee (insulin glargine-yfgn), an insulin glargine biosimilar developed by Indian company Biocon, has been listed as a preferred brand by one of the USA’s largest pharmacy benefit managers, Express Scripts. 21 October 2021
Biotechnology
The US medicines cost watchdog the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of eculizumab and efgartigimod for the treatment of generalized myasthenia gravis (gMG). 20 October 2021
Biotechnology
Biogen’s novel Alzheimer’s (AD) therapy is struggling to clear the launch pad, generating just $300,000 in the first quarter in which it became available. 20 October 2021
Biotechnology
Drug price disruptor EQRx has signed a memorandum of understanding (MoU) with the UK’s National Health Service, outlining plans for a long-term partnership to supply medicines. 20 October 2021
Pharmaceutical
A positive reimbursement decision in the UK will see patients in England and Wales gain access to Boehringer Ingelheim’s Ofev (nintedanib) through the country’s national healthcare provider. 18 October 2021
Pharmaceutical
Irish pharmaceuticals trade group the IPHA has welcomed the provision of 30 million euros ($35 million) for new medicines in the Government’s recent budget. 18 October 2021
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Dupixent (dupilumab), as an add-on maintenance treatment for severe asthma. 18 October 2021
Biosimilars
The Biosimilars Forum, in partnership with the Pacific Research Institute PRI), released a report and interactive tool highlighting the billions of dollars that biosimilars can save states. 14 October 2021
Pharmaceutical
Since Donald Trump’s 2018 “American Patients First” plan, and long before, drug pricing in the USA has been both a lightning rod for strong opinions and stubbornly resistant to reform. 12 October 2021
Pharmaceutical
Hot on the heels of Merck & Co filing for emergency use of its COVID-19 candidate molnupiravir, the international medical humanitarian organization Médecins Sans Frontières (MSF) has struck out to have affordable access of the drug for poorer countries. 12 October 2021
Pharmaceutical
A number of leading patient organizations in Russia have called on the national government to increase procurements of drugs against hepatitis C, according to recent statements by representatives of associations and some local media, reports The Pharma Letter’s local correspondent. 12 October 2021
Pharmaceutical
US drugmaker Bristol Myers Squibb has hit back at an Institute for Clinical and Economic Review (ICER) assessment on the comparative clinical effectiveness and value of its drug mavacamten for the treatment of hypertrophic cardiomyopathy (HCM). 8 October 2021
Pharmaceutical
At a meeting this month, an Institute for Clinical and Economic Review (ICER) committee will assess the comparative clinical effectiveness and value of Bristol Myers Squibb’s mavacamten for the treatment of hypertrophic cardiomyopathy (HCM). 7 October 2021
Biotechnology
For the first time in 20 years, a new therapy for sickle cell disease is to be made available on the UK's National Health Service (NHS). 5 October 2021
Pharmaceutical
The list of rare (orphan) diseases, which consists of more than 200 diseases in Russia, needs to be updated, according to recent statements by Galina Izotova, deputy chairman of the Russian Audit Chamber. 5 October 2021
Generics
Three generic pharmaceutical manufacturers, Taro Pharmaceuticals USA, Sandoz, the biosimilars and generics business of Novartis and Apotex Corp, have agreed to pay a total of $447.2 million to resolve alleged violations of the False Claims Act arising from conspiracies to fix the price of various generic drugs. 2 October 2021
Generics
European customers are growing increasingly concerned about the origin of their medicine and expect government to support investment to avoid over dependency on countries outside of Europe. 2 October 2021
Pharmaceutical
The Russian government, together with the Federal Antimonopoly Service (FAS), have agreed to raise prices for more than 30 drugs from the list of vital and essential since January of the current year, reports The Pharma Letter’s local correspondent. 1 October 2021
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