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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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Biotechnology
The 2012 UK Life Science Industry Leaders Survey* highlights a concern that the UK is losing its position as a center for global R&D. Nick Stephens, chief executive of executive search organization RSA, presents results from the survey and draws out some themes that are relevant to the industry as a whole. 16 December 2011
Biotechnology
A surge in the medicines budget over the past three years, combined with New Zealand's health regulatory agency PHARMAC's savings programs, has seen PHARMAC investing heavily in new medicines. 15 December 2011
Generics
Ensuring the Pharmaceutical Benefits Scheme (PBS) is sustainable and medicines remain affordable and accessible to all Australians regardless of where they live or what their socio economic background is, must be a priority for the new Minister for Health, Tanya Plibersek (The Pharma Letter December 13), said the country's Generic Medicines Industry Association (GMiA), welcoming Ms Plibersek to her new Cabinet role. 14 December 2011
Pharmaceutical
There was mixed news this morning from the UK's National Institute for Health and Clinical Excellence (NICE), when the agency published final guidance on AstraZeneca's (LSE: AZN) breast cancer drug Faslodex (fulvestrant) and Roche's (ROG; SIX) RoActemra (tocilizumab) in young children. 14 December 2011
Pharmaceutical
In another swipe at US pharma giant Merck & Co (NYSE: MRK), the AIDS Healthcare Foundation (AHF) has launched a new advocacy campaign calling for the drug company to lower its prices for cash-strapped AIDS Drug Assistance Programs (ADAPs). 12 December 2011
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today issued final draft guidance on the use of US drug giant Merck & Co's Daxas (roflumilast) recommends setting up a clinical trial to establish how effective it is for adults with severe chronic obstructive pulmonary disease, associated with chronic bronchitis, as an add-on to bronchodilator treatment for people with a history of frequent exacerbations. 8 December 2011
Pharmaceutical
Dipeptidyl peptidase IV (DPP-IV) inhibitors are prescribed more commonly for the treatment of type 2 diabetes in South Korea than in China, and in earlier lines of therapy, according to surveyed physicians in these countries carried out by advisory firm Decision Resources. At the time the survey was conducted, two such oral agents were available in South Korea ' US drug giant Merck & Co's (NYSE: MRK) Januvia (sitagliptin) and Swiss major Novartis' (NOVN: VX) Galvus (vildagliptin), while only Januvia was available in China. 7 December 2011
Pharmaceutical
More than 160,000 patients will benefit directly from changes to Australia's Pharmaceutical Benefits Scheme (PBS) from this month, including people being treated for cancer, HIV and chronic obstructive pulmonary disease, the government has announced. 7 December 2011
Pharmaceutical
In new draft guidance, the UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has recommended Tasigna (nilotinib) and Glivec (imatinib) both made by Swiss drug major Novartis' (NOVN: VX) for the first line treatment of CML (chronic myeloid leukemia) in the National Health Service. However, the NICE has not recommended Sprycel (dasatinib) from US drugmaker Bristol-Myers Squibb (NYSE: BMY). 6 December 2011
Pharmaceutical
Turkey's Association of Research-Based Pharmaceutical Companies (AiFD) has expressed concerns about discounts in public drug purchase, which were increased with the changes made by the Social Security Institution Health Application Announcement on November 5, 2011, and in addition, drug prices which were reduced by the Decree on Amendment of the Decree on Pricing of Medicinal Products for Human Use which was published on November 10, 2011. However, the increase in exchange rates was not reflected in the prices despite the main provision of Price Decree and Announcement. 6 December 2011
Pharmaceutical
Data from Spain's Ministry of Health, Social Policy and Equality show that, in September 2011 (the latest published figures), public pharmaceutical expenditure experienced a new drop of 6.2% compared to the same month the previous year. This variation is a consequence of a reduction in the number of prescriptions (-0.2%), and of a fall in the average cost of prescriptions (-6.0%), noted the pharmaceutical trade group Farmaindustria. 5 December 2011
Generics
Three prominent US Senators have sent letters to pharma behemoth Pfizer (NYSE: PF), as well as three companies that manage pharmaceutical benefits and two insurance firms, asking for information about agreements aimed at limiting the sale of atorvastatin, the generic equivalent of Pfizer's drug Lipitor, which lost patent protection in the USA on Wednesday. So-called 'authorized' copy versions - with 180 days of market exclusivity - of the all-time blockbuster cholesterol lowerer have already been launched by Watson Pharmaceuticals and Ranbaxy Laboratories (The Pharma Letter December 1). 2 December 2011
article
US Senator Herb Kohl (Democrat, Wisconsin), Chairman of the Special Committee on Aging, held a hearing this week examining the widespread inappropriate use of antipsychotics among nursing home residents suffering from dementia, high costs to taxpayers and the efforts to find safe and effective alternatives. 2 December 2011
Pharmaceutical
UK NICE says Novartis MS drug Gilenya not cost effective, but backs extended use of Roche's MabThera
In further draft guidance published today (December 1), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) says it has not been able to recommend Swiss drug major Novartis' (NOVN: VX) Gilenya (fingolimod) that could reduce relapses in some people who have a particular type of multiple sclerosis. The guidance is open to consultation until January 5, 2012. 1 December 2011
Pharmaceutical
The National Institute for Health and Clinical Excellence (NICE), in final guidance issued today (November 30), the UK drug watchdog, confirmed its previous negative guidance and has not recommended Swiss drug major Novartis' Lucentis (ranibizumab) for the treatment of diabetic macular edema (DMO: The Pharma Letter November 24).The drug retains its NICE backing for use in the National Health Service for the treatment of neovascular (wet) age-related macular degeneration (AMD), 30 November 2011
Pharmaceutical
In a batch of mixed news coming from the UK's National Institute for Health and Clinical Excellence (NICE) this morning, the agency has issued final draft guidance not recommending the use of Erbitux (cetuximab) from Merck Serono, a unit of Germany's Merck KGaA (MRK: DE), Swiss major Roche's (ROG: SIX) Avastin (bevacizumab) and US biotech firm Amgen's Vectibix (panitumumab) for the treatment of metastatic colorectal cancer that has progressed after first line chemotherapy. 25 November 2011
Pharmaceutical
As of next September, a different vaccine will be used in the HPV vaccination program to protect girls from cervical cancer, the UK Department of Health has announced yesterday. Following a competitive tendering exercise, Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] Vaccine, Recombinant), supplied by Sanofi Pasteur MSD, a joint venture of the USA's Merck & Co (NYSE: MRK) and France's Sanofi (Euronext: SAN), will be the vaccine used in the next school year, thus switching from current supplier GlaxoSmithKline's Cervarix (human papillomavirus bivalent [types 16 and 18] vaccine, recombinant). 25 November 2011
Pharmaceutical
In preliminary recommendations published today (November) 24 by the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) Swiss drug major Novartis' (NOVN: VX) Lucentis (ranibizumab) is not recommended for the treatment of visual impairment caused by macular odema secondary to central or branch retinal vein occlusion. 24 November 2011
Pharmaceutical
Swiss drug major Novartis' (NOVN: VX) Ilaris (canakinumab), a treatment for cryopyrin-associated period syndrome (CAPS) which gained marketing approval in Japan a couple of months ago (The Pharma Letter September 28), has now received National Health Insurance (NIH) price listing from the Central Social Insurance Medical Council (CSIMC; Chuikyo). 23 November 2011
Biotechnology
Sales of Dendreon's (Nasdaq: DNDN) new prostate cancer treatment Provenge (sipuleucel-T) have been disappointing so far, partly as a result of its high cost of around $93,000 per round of therapy and the fact that, despite being approved by the US Food and Drug Administration in April 2010, Medicare did not make a final decision to cover the product's cost until June this year. 21 November 2011
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