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Pharmaceutical
The USA's Office of Pharmacy Affairs (OPA) of the Health Resources Services Administration (HRSA) has published its first proposed regulation under the 340B Drug Discount Program since the Program was established in 1992 in the Federal Register to implement health reform orphan drug exclusion. 24 May 2011
Biotechnology
Demand for biopharmaceuticals continued to expand in Germany last year. Turnover in the genetically engineered drugs sector jumped by 8% to 4.9 billion euros ($6.96 billion) and now accounts for 17% of the overall drugs market. 23 May 2011
Pharmaceutical
In the USA, 10% of cancer patients failed to fill their initial prescriptions for oral anti-cancer drugs, according to a new study published jointly in the Journal of Oncology Practice (JOP) and American Journal of Managed Care (AJMC). The study was based on an analysis conducted by Avalere Health using pharmacy transaction data over a two-year period from 2007 to 2009. 20 May 2011
Pharmaceutical
Expensive new cancer drugs treating increasing numbers of patients could drive cancer drug spending by as much as 15% a year through 2013. At this accelerated rate, oncology drugs will likely rise to the second or third largest trend-driving category by 2015, following only diabetes and central nervous system (CNS) treatments, according to the newly-released 2011 Medco Drug Trend Report which tracks utilization and spending. 19 May 2011
Pharmaceutical
Times are hard for pharmaceutical companies in Turkey, particularly research-based ones, who are left without breathing room due to the price cuts, a single means by which the country's government is trying to address budgetary shortfalls over the past two years. A survey of the members of Association of Research-Based Pharmaceutical Companies (AİFD) uncovered the concerns that are troubling the sector. 18 May 2011
Generics
The US Trustees of the Social Security and Medicare trust funds report on the current and projected financial status of the two programs warns that, if the 2010 health care reform legislation does not achieve its expected cost saving, the programs will not have sufficient funding. 16 May 2011
Pharmaceutical
As part of its latest budget announcement, Australia's federal government has allocated A$2.2 billion ($2.37 billion) funding for mental health, under a five-year reform package. These reforms are aimed at improving the lives of thousands of Australians with mental illness by: 11 May 2011
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday announced three items of news regarding its potential blockbuster blood thinner Brilique/Brilinta (ticagrelor), which late last year gained European Marketing approval (The Pharma Letter December 6, 2010) but is still awaiting clearance in the all-important US market. 10 May 2011
Generics
Although drugs remain an important cost driver in Canada's health system, growth in spending has slowed to its lowest rate in 14 years, according to a new report released last week by the Canadian Institute for Health Information (CIHI). 9 May 2011
Pharmaceutical
A bipartisan bill, S 733, designed to address a Medicare reimbursement flaw and seeking to reverse cancer care payment shortfalls has been introduced in the USA by Senator Pat Roberts (Republican, Kansas) and lead co-sponsor Senator Debbie Stabenow (Democrat, Michigan). 9 May 2011
Pharmaceutical
The UK's drug rationing body the National Institute for Health and Clinical Excellence (NICE) yesterday published its new draft guidance on leukemia drugs Sprycel (dasatinib from Bristol-Myers Squibb (NYSE: BMY) and high-dose Glivec (imatinib) and Tasigna (nilotinib), both from Novartis (NOVN: VX), saying it has not been able to recommend the products for the treatment of chronic myeloid leukemia (CML) that is resistant to standard-dose imatinib on the National Health Service. 6 May 2011
Pharmaceutical
Australia's federal government is ignoring its own growth forecasts for the Pharmaceutical Benefits Scheme (PBS), and making policy decisions without an evidence base, trade group Medicines Australia chief executive Brendan Shaw told industry experts in Sydney yesterday. 6 May 2011
Pharmaceutical
Australia's Federal Health Minister, Nicola Roxon has refused to back down from the government's decision to defer the Pharmaceutical Benefits Scheme (PBS) listing of critical drugs. 3 May 2011
Pharmaceutical
The apparent surge in pharmaceutical prices included in yesterday's Australian Bureau of Statistics Consumer Price Index for the March quarter is easily explained by the mechanics of the Pharmaceutical Benefits Scheme safety net, said trade group Medicines Australia chief executive Brendan Shaw. 28 April 2011
Generics
Growth in US spending on medicines slows to 2.3% in 2010, says IMS 21 April 2011
Pharmaceutical
Final draft guidance published last week by the UK drug rationing body the National Institute for Health and Clinical Excellence (NICE) confirms its previous positive draft recommendation for naftidrofuryl oxalate as an option to treat people who suffer from intermittent claudication caused by peripheral arterial disease and for whom vasodilator therapy is considered appropriate after taking into account other treatment options. 18 April 2011
Pharmaceutical
A large percentage of US health plans (78%) will reimburse for emerging oral disease-modifying therapies for multiple sclerosis, despite the projected high cost associated with these agents, according to a report from advisory firm Decision Resources' HealthLeaders-InterStudy unit. 18 April 2011
Pharmaceutical
In a bid to cut budgets, National Health Service (NHS) managers in the UK are preventing family doctors from prescribing drugs for conditions such as diabetes, heart disease, Parkinson's disease and osteoporosis, adding the medicines to so-called "red lists," which means they can only be prescribed by a hospital consultant and not a General Practitioner. 14 April 2011
Pharmaceutical
Following the introduction of National Health Insurance (NHI) in 1995, the Israeli government's role in the pharmaceutical sector significantly increased. The first few years saw the establishment of a NHI basket of services with a process for updating, a greater involvement in co-payment policy (leading to a 50% increase in prescription copayments in 1998), changes to the Patent Law and data exclusivity regulations, as well as a number of pricing reforms, according to a report written by Dr Philip Sax, editor of the Israeli PHARMA Drug Bulletin. 12 April 2011
Pharmaceutical
The USA should pay close attention to how the UK carries out plans to assess a new drug's worth using factors that go beyond clinical and cost effectiveness, according to researchers at the Johns Hopkins Berman Institute of Bioethics. 11 April 2011
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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