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Pharmaceutical
German pharma company Merck has expressed disappointment after the National Institute for Health and Care Excellence (NICE) failed to recommend two specific personalized treatments - cetuximab and panitumumab – for first line treatment in combination with chemotherapy of metastatic colorectal cancer 17 November 2015
Pharmaceutical
Although retained for use through the Cancer Drugs Fund, Swiss pharma giant Roche’s breast cancer combination treatment will not be recommended for routine National Health Service use in England because its price remains too high. 17 November 2015
Pharmaceutical
Around 2.7 million people tend to die of cardiovascular problems annually in India. With the figure projected to soar by 1.5 million by 2030, non-communicable diseases and their risk factors are turning out to be the leading cause of mortality, reports The Pharma Letter’s India correspondent. 16 November 2015
Biotechnology
A drug approved to treat rheumatoid arthritis, tocilizumab, is a potential new therapy for patients with polymyalgia rheumatica, according to an open-label, Phase II study presented at the annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals yesterday. 11 November 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether Lixiana (edoxaban) from Japanese drug major Daiichi Sankyo offers an added benefit over the appropriate comparator therapy. 6 November 2015
Pharmaceutical
With the US Senate launching an investigation into the steep drug price hikes, the ongoing debate on the pharmaceutical industry’s pricing mechanism is once again under the scanner. 5 November 2015
Pharmaceutical
US Senators Susan Collins (Republican, Maine) and Claire McCaskill (Democrat, Missouri), who together lead the Senate Special Committee on Aging, today announced a bipartisan Senate investigation into the pricing of pharmaceutical products. 4 November 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has today published final draft guidance recommending Ikervis (ciclosporin), from Japanese drugmaker Santen Pharmaceuticals, for treating severe keratitis in adults with dry eye disease which has not improved despite treatment with artificial tears. 4 November 2015
Pharmaceutical
Australia’s Turnbull government says it will address inconsistencies in the nation’s Pharmaceutical Benefits Scheme (PBS) that see many concessional patients with a prescription for common medicines such as paracetamol and aspirin paying higher prices than if they simply purchased them over the counter. 3 November 2015
Pharmaceutical
Australia is now offering Iclusig (ponatinib) for chronic myeloid leukemia from biopharma company Specialised Therapeutics Australia under license from Ariad Pharmaceuticals as part of the Pharmaceutical Benefits Scheme (PBS). 2 November 2015
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended against routine funding of US biotech firm Celgene Corp’s (Nasdaq: CELG) Abraxane (nab-paclitaxel), to treat pancreatic cancer saying the cost of the drug does not justified the benefits compared to current treatments. 28 October 2015
Pharmaceutical
The National Institute for Health and Care Excellences (NICE), the medicines watchdog for England and Wales, today published draft guidance provisionally recommending four drugs for treating a form of arthritis in children and young people. 22 October 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has today published draft guidance recommending US pharma giant Merck & Co’s Ezetrol (ezetimibe) as an option for some adults with primary (heterozygous-familial and non-familial) hypercholesterolemia. 21 October 2015
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in a dossier assessment whether US pharma major Bristol-Myers Squibb’s Opdivo (nivolumab) offers an added benefit over the appropriate comparator therapy for advanced melanoma. 20 October 2015
Pharmaceutical
In final draft guidance issued today, the National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has recommended Danish CNS specialist Lundbeck’s Brintellix (vortioxetine) for some adults with major depressive disorder 16 October 2015
Biotechnology
In draft guidance produced by its Highly Specialised Technologies program, England and Wales medicines watchdog the National Institute for Health and Care Excellence (NICE) has today asked for further clarification from US biotech firm PCT Therapeutics on the size of the benefit its drug Translarna (ataluren) provides in the treatment of a type of Duchenne muscular dystrophy (DMD). 16 October 2015
Biotechnology
Following preliminary positive recommendations announced in July, The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, is now set to recommend three new treatments for some adults with hepatitis C, the agency announced today. 16 October 2015
Pharmaceutical
Canadian drugmaker Valeant Pharmaceuticals International has responded to a letter from US Senator Claire McCaskill (Democrat, Missouri) concerning pricing of the company's products Nitropress (nitroprusside) and Isuprel (isoproterenol). 15 October 2015
Pharmaceutical
The Scottish Medicines Consortium (SMC) has made decisions on three products. 12 October 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence has issued final draft guidance recommending Keytruda (pembrolizumab) from Merck to treat advanced skin cancer not treated with ipilimumab. 9 October 2015
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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