Pricing, reimbursement and access
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Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Speaking today at the annual meeting of the Association of the British Pharmaceutical Industry (ABPI), its chief executive, Stephen Whitehead, told company leaders that the UK must prioritize patient access to lifesaving medicines, and ensure proper funding for the development of new, innovative treatments, or run the risk of failing to meet the demands of tackling diseases in the future. 25 April 2012
Generics
Generic drugs are expected to help countries cope with health care cuts brought about by strict austerity measures, according to a new report by business intelligence experts GBI Research. The new report suggests that lower priced generic drugs help control costs, saving patients, drug manufacturers, retailers and the government a considerable amount of money. 25 April 2012
Pharmaceutical
Across OECD countries some 83 million people suffer from diabetes and, on current trends, that will rise to almost 100 million by 2030. Like other chronic diseases, diabetes reduces employment opportunities and earnings. In addition, diabetics are prone to depression, making it difficult to follow treatment guidelines. 25 April 2012
Pharmaceutical
In final guidance issued this morning, UK drugs watchdog the National Institute for Health and Clinical Excellence ( NICE) has recommended National Health Service use of Tasigna (nilotinib) and Glivec (imatinib), both made by Swiss drug major Novartis (NOVN: VX), for the first line treatment of chronic myeloid leukemia (CML), confirming draft guidance issued last month (The Pharma Letter March 22). 25 April 2012
Pharmaceutical
The pace of Australia's headline Consumer Price Index (CPI) inflation rose just slightly in the March quarter taking the annual pace of increase below the mid-point of the Reserve Bank of Australia's 2% to 3% target band, according to Market News International. The headline consumer price index rose 0.1% on-quarter in the March quarter compared with a flat outcome in the December quarter, taking the year-on-year increase down sharply to 1.6% rise versus 3.1% increase in the December quarter, the Australian Bureau of Statistics said Tuesday. 24 April 2012
Pharmaceutical
The Canadian Agency for Drugs and Technologies in Health (CADTH) through the Common Drug Review (CDR), has positively recommended to Canada's provincial and other publicly funded drug plans that they reimburse German drug major Bayer's (BAY: DE) once-daily oral anticoagulant Xarelto (rivaroxaban tablet), for the prevention of stroke and systemic embolism in patients with non-valvular AF, in whom warfarin is indicated, and who meet all of the following criteria: are unable to achieve adequate anticoagulation with warfarin and have a CHADS2 score of 2. 24 April 2012
Pharmaceutical
The German Federal Joint Committee (G-BA), the supreme decision-making body of the self-governing medical system in Germany, says that it considers the use of Japanese drug major Eisai's (TYO: 4523) Halaven (eribulin) to have additional benefit versus comparative treatments, defined by the G-BA for women who have already had extensive prior treatment of metastatic or locally advanced breast cancer. The decision comes despite a negative initial assessment by the G-BS's advisory body, the IQWiG (The Pharma Letter February 17). 23 April 2012
Pharmaceutical
UK drug watchdog the National Institute for Health and Clinical Excellence (NICE), said this morning that it has opened a consultation on new, draft guidance which does not recommend Avastin (bevacizumab), from Swiss drug major Roche (ROG: SIX), for the first-line treatment of metastatic breast cancer, when used in combination with the chemotherapy drug, capecitabine. 18 April 2012
Pharmaceutical
In an early benefit assessment under to the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Sativex, a cannabis-based treatment for moderate to severe spastic paralysis and muscle spasms due to multiple sclerosis (MS) offers an added benefit over the optimized standard therapy. 17 April 2012
Pharmaceutical
The South African government has announced the designation of certain pharmaceutical products for domestic production. The announcement that was made by Trade and Industry Minister, Rob Davies in Pretoria, is the second wave of the designation and is in line with the amended Regulations to the Preferential Procurement Policy Framework Act (PPPFA). 16 April 2012
Biotechnology
USA-based Affymax (Nasdaq: AFFY) and the US subsidiary of Japanese drug major Takeda Pharmaceuticals (TYO: 4502) revealed on Friday that the Centers for Medicare and Medicaid Services (CMS) has granted a unique product reimbursement code, or Q-code, for Omontys (peginesatide) Injection. The move follows Food and Drug Administration approval of the drug last month for the treatment of anemia due to CKD in adult patients on dialysis. (The Pharma Letter March 28). 16 April 2012
Generics
Due to legislative changes implemented during 2011 in most of the Central European (CE) countries, the innovative drug market in the region will decline in 2012 by 1%, to €6.1bn at manufacturer prices, according to the latest report published by Poland-based research and consulting company PMR. 16 April 2012
Pharmaceutical
As part of an official Danish state visit to Kenya, global insulin giant Novo Nordisk (NOV: N) last week officially launched a program to make insulin and diabetes care more accessible to poor populations. 15 April 2012
Pharmaceutical
The biggest round of price cuts in the history of the Australian Pharmaceutical Benefits Scheme, coupled with historically low spending growth have removed any justification for further PBS cuts in the Federal Budget, pharma trade group Medicines Australia chief executive Brendan Shaw told an industry conference yesterday. 12 April 2012
Pharmaceutical
Women with aggressive metastatic breast cancer in the UK capital London now have access to a drug which could give them five-10 extra months of life but up until this month has been unavailable on the National Health Service, says Swiss drug major Roche (ROG: SIX). 12 April 2012
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed Vyndaqel (tafamidis), a treatment for a rate neurological disorder the pharma behemoth Pfizer (NYSE: PFE), at the request of the Federal Joint Committee (G-BA), saying that it has found "a hint of a positive effect" of tafamidis on neurological degeneration. 11 April 2012
Generics
India Health Progress has released the analysis presented by Dileep Malvankar, Dean of Public Health, Gandhinagar, on the recommendations made by the High Level Expert Group for the implementation of universal health care coverage in India by 2022. 10 April 2012
Pharmaceutical
There was good news last week for USA-based InterMune (Nasdaq: ITMN) when the Transparency Commission (CT: Commission de Transparence) of the French National Health Authority (HAS: Haute Autorite de Sante) issued a favorable opinion for the reimbursement of its lung drug Esbriet (pirfenidone) by French National Health Insurance. The news drove the stock 10% to $15.28. 10 April 2012
Pharmaceutical
As a result of government bureaucracies to approve new prescription drugs for public use, Canadians are waiting nearly two-and-a-half years, according to a new report from the Fraser Institute, the leading public policy think-tank in Canada. 9 April 2012
Biotechnology
Total health care spending on medicines in the USA increased 3.7% to $320 billion in 2011, a year which saw the most medicines launched in a decade bringing new, transformative treatment options to more than 20 million Americans. At the same time, US patients overall visited their physicians less often and used fewer prescription drugs compared with 2010, according to a new report from the IMS Institute for Healthcare Informatics. 5 April 2012
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