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Biotechnology
The UK’s National Health Service (NHS) and the company leading drug development in cystic fibrosis (CF) remain at loggerheads. 20 March 2018
Pharmaceutical
It was nearly 16 years ago that the last new treatment for Alzheimer’s was approved by European regulators, with the US Food and Drug Administration also approving Namenda (memantine) the following year. 20 March 2018
Biotechnology
The USA’s Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of Hemlibra (emicizumab). 19 March 2018
Pharmaceutical
New research results from Regeneron Pharmaceuticals and partner Sanofi on their PCSK9 drug Praluent and a novel scheme to improve access to the expensive drug attracted a great deal of attention last week, as did late-stage trial results with AbbVie’s elagolix for uterine fibroids. In deal-making news, there was Biogen picking up Pfizer’s neurological cast-off PF-04958242, and Lundbeck acquiring Prexton Therapeutics along with its Parkinson’s disease drug foliglurax, as well as Ionis Pharmaceuticals upping its stake in Akcea Therapeutics and off-loading its rare disease drug candidate inotersen. 18 March 2018
Pharmaceutical
In 2017, £9.17 billion ($12.7 billion) was the cost of prescriptions dispensed in England, representing decrease of 0.41% (£37.6 million) from 2016, according to a new report released by NHS Digital. 17 March 2018
Pharmaceutical
To address rising health care costs and help patients better access new medicines, biopharmaceutical companies are sharing financial risk with payers through new payment arrangements, like value-based contracts or results-based contracts (RBCs), which link reimbursement to patient outcomes. 16 March 2018
Biotechnology
Merck & Co’s Keytruda (pembrolizumab) has been recommended for patients in England and Wales within the Cancer Drugs Fund (CDF) as an option for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy. 15 March 2018
Biotechnology
The Institute for Clinical and Economic Review (ICER) has released a Preliminary New Evidence Update for Praluent (alirocumab) based on results from the ODYSSEY outcomes trial presented at last weekend’s American College of Cardiology’s 2018 Scientific Session. 14 March 2018
Pharmaceutical
The US President’s Cancer Panel’s 2018 report says that “addressing the dramatic rise of cancer drug prices must be made a national priority.” 13 March 2018
Pharmaceutical
In a report highlighting the company’s record on corporate responsibility, Johnson & Johnson notes that the average list price increase for its medications was in the single-digit percentages last year. 12 March 2018
Biotechnology
French drugmaker Sanofi and Regeneron Pharmaceuticals have announced positive data from the ODYSSEY OUTCOMES trial of cardiovascular therapy Praluent (alirocumab). 12 March 2018
Pharmaceutical
János Lázár, the Minister heading the Prime Minister of Hungary’s Office announced at a Kormányinfó (government information) event that, from January 1, 2019, the varicella (chickenpox) vaccine will be included among the age-related vaccines provided free of charge, which is another major step in the fight against the disease associated with severe complications in some cases. 12 March 2018
Pharmaceutical
When it comes to medicines, many stakeholders in health systems around the world would agree on a couple of points – paying for drugs has become too expensive, and unless something changes drastically, the problem is only going to get worse. 9 March 2018
Biotechnology
New Zealand’s Pharmaceutical Management Agency PHARMAC is proposing to widen access to tenofovir disoproxil and entecavir, antiviral medicines used for the treatment of hepatitis B and HIV. 9 March 2018
Biotechnology
Japan’s switch to generic drugs from brand-name medicines is expected to have reduced the country’s medical costs by 1.3 trillion yen ($12. 3 billion) in fiscal 2017, according to a Ministry of Health, Labor and Welfare (MHLW) announcement reported by local media. 7 March 2018
Pharmaceutical
USA-based UnitedHealthcare, a UnitedHealth Group (NYSE: UNH) company, announced on Tuesday that it will expand pharmacy discounts to millions of its plan participants when they fill prescriptions through retail pharmacies or home delivery. 7 March 2018
Pharmaceutical
A new collaboration between pharmaceutical companies and non-profit organizations will manufacture and supply a new, more affordable, hepatitis C treatment regimen in Latin America. 6 March 2018
Generics
Mylan on Friday announced that it will launch two new HIV treatments, Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) and Cimduo (efavirenz/lamivudine/tenofovir disoproxil fumarate). 5 March 2018
Pharmaceutical
The Russian government plans to start investigation of the activities of some leading domestic and global drugmakers operating in the local market, due to their activities for the prevention of introducing a system of drug labeling in the country, according to recent statements by Russia’s Deputy Prime Minister Igor Shuvalov, reports The Pharma Letter’s Russia correspondent. 26 February 2018
Pharmaceutical
Following litigation over pregabalin’s second-use medical patent for neuropathic pain NHS England were required by the court to instruct GPs to prescribe the branded form (Lyrica) for Pain, notes a new study led by Oxford University researchers and published by BioRxiv. 26 February 2018
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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