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Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has in final guidance issued today said “yes” to pembrolizumab for treating advanced skin cancer after treatment with ipilimumab. 7 October 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether ceritinib offers an added benefit over the appropriate comparator therapy. 6 October 2015
Pharmaceutical
Speaking at European Health Forum Gastein, which took place in Austria last week, European Commissioner for Health Vytenis Andriukaitis called for a new partnership between pharmaceutical companies and European Union member states to ensure access to medicines while securing the future of bio-pharmaceutical innovation. 4 October 2015
Pharmaceutical
A pressure group has called on the UK’s Health Secretary Jeremy Hunt to grant a compulsory license for patents that cover Kadcyla (trastuzumab emtansine) from Roche. 2 October 2015
Pharmaceutical
Quebec-based pharma company Valeant is the target of US lawmakers seeking to take action over price increases of its cardiovascular drugs, sending shares sliding 20%. 29 September 2015
Biotechnology
The European Commission has granted marketing authorization for Praluent (alirocumab) for the treatment of low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolemia. 28 September 2015
Pharmaceutical
The USA-based AIDS Healthcare Foundation (AHF) has denounced the lack of regulation and pharmaceutical industry greed that has led to record drug prices for specialty medications and billions of dollars in profits for drug manufacturers. 25 September 2015
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI) has responded to discussion in the UK media on the price of medicines in the country. 25 September 2015
Biotechnology
The UK medicines cost watchdog the National Institute for Health can Care Excellence (NICE) today issued final draft guidance recommending that US biotech giant Gilead Sciences’ Zydelig (idelalisib) should be made available on the National Health Service in England and Wales for some adults with chronic lymphocytic leukemia (CLL). 24 September 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Lixiana (edoxaban) from Daiichi Sankyo to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation. 23 September 2015
Biotechnology
Hillary Clinton, the frontrunner Democratic presidential candidate in the USA, has said that, if elected, she would implement programs to force the pharmaceutical industry to concede tens of billions of dollars a year in tax breaks, lower prices and increase research spending. 23 September 2015
Pharmaceutical
An Australian Senate Committee inquiry has issued its findings and has recommended the government reviews the way in which new medicines are approved and subsidized. 18 September 2015
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued its Final Appraisal Determination (FAD) to not recommend US biotech major Celgene’s Abraxane (nab-paclitaxel) in combination with gemcitabine, for adults with previously untreated metastatic adenocarcinoma of the pancreas (metastatic pancreatic cancer). 17 September 2015
Biotechnology
The UK's National Institute for Health and Clinical Excellence (NICE) on Wednesday confirmed its earlier final draft guidance not to recommend collagenase clostridium histolyticum (Xiapex, from Swedish Orphan Biovitrum), to treat Dupuytren’s contracture for routine use. 16 September 2015
Generics
The Indian Pharmaceutical Alliance (IPA) has dropped its opposition to Gilead’s patent application for Sovaldi (sofosbuvir), as the company has voluntarily made a licensing agreement with 11 companies to sell a lower-cost generic. 15 September 2015
Pharmaceutical
A new report offers a comprehensive review of currently-available evidence on two new interventions that have triggered significant interest as potential advances in the care of patients with congestive heart failure (CHF). 15 September 2015
Pharmaceutical
The medicines watchdog for England and Wales, the National Institute for Health and Care Excellence (NICE), has today published preliminary draft guidance which recommends National Health Service use of Ofev (nintedanib), from German family-owned pharma major Boehringer Ingelheim. 11 September 2015
Biotechnology
A draft report released by the USA-based Institute for Clinical and Economic Review (ICER) has again focused on the cost of the new class of cholesterol lowering drugs known as PCSK9 inhibitors, with the independent non-profit organization concluding that these are too expensive for general use. 9 September 2015
Biotechnology
The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England and Wales, has published final draft guidance today which does not recommend US biotech major Celgene Otezla (apremilast) for adults with active psoriatic arthritis that has either not responded to disease-modifying antirheumatic drug (DMARD) therapy, or where such therapy is not tolerated. 3 September 2015
Pharmaceutical
In final draft updated guidance published today, UK medicines cost watchdog the National Institute for Health and Care Excellence (NICE) confirms its recommendations for treatment options for people with rheumatoid arthritis. 3 September 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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