Pricing, reimbursement and access
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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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Generics
The European Court of Justice today issued a ruling in relation to the case that drug companies supplying an antidepressant called paroxetine broke the law. 30 January 2020
Pharmaceutical
Texas, USA-based Vizient has released its Winter 2020 Drug Price Forecast projecting that health systems, including inpatient and non-acute environments, can expect a 3.59% increase for pharmaceutical purchases made from July 1 to June 30, 2021. 30 January 2020
Pharmaceutical
UK cancer patients have had to wait longer for innovative new cancer drugs than for more conventional treatments, pointing to a failure to successfully fast track these exciting drugs, according to a new analysis. 29 January 2020
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued draft guidance not to recommend Spravato (esketamine) nasal spray. 28 January 2020
Pharmaceutical
The US Federal Trade Commission has filed a complaint in federal court against Vyera Pharmaceuticals, LLC alleging an elaborate anticompetitive scheme to preserve a monopoly for the life-saving drug Daraprim (pyrimethamine). 28 January 2020
Pharmaceutical
Zulf Masters, chief executive of Masters Speciality Pharma, provides an Expert View on the challenges and opportunities of bringing medicines to Latin America. 27 January 2020
Pharmaceutical
Rapid report shows how routine practice data should be used and processed. Therefore, first data from high-quality registries will presumably soon be considered in benefit assessment of drugs, says Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) 27 January 2020
Pharmaceutical
As the general election campaign began its second week, the Irish Pharmaceutical Healthcare Association (IPHA) urged all political parties to pledge to improve patients’ access to new medicines as part of their plans for health. 27 January 2020
Biotechnology
A negative decision from the National Institute for Health and Care Excellence (NICE) threatens the reimbursement potential for Stelara (ustekinumab) in the UK. 23 January 2020
Biosimilars
Today, Pfizer announced it is introducing three new biosimilars, Zirabev (bevacizumab-bvzr) referencing Avastin, Ruxience (rituximab-pvvr) referencing Rituxan, and Trazimera (trastuzumab-qyyp) referencing Herceptin, at a substantially discounted price to the originator product in the USA, which has been a notoriously difficult market for copy biologics to enter. 23 January 2020
Generics
Netherlands-based drugmaker Tiofarma has admitted that it took part in an agreement that resulted in significant price hikes in the UK for an essential medicine. 23 January 2020
Pharmaceutical
In November 2019, China updated its National Reimbursement Drug List (NRDL) to include 70 new medicines, with an average price cut of 61% agreed by pharma companies. 23 January 2020
Pharmaceutical
Cancer medicines cost nearly twice as much in hospital outpatient facilities than in physician offices in the commercial market, according to a new study from the Employee Benefit Research Institute Center for Research on Health Benefits Innovation. 22 January 2020
Pharmaceutical
Despite an appeal by AstraZeneca, the National Institute of Health and Care Excellence (NICE) has published final guidance that does not recommend the use of its drug Tagrisso (osimertinib) in a lung cancer indication. 22 January 2020
Generics
The second round of China’s national generics procurement, which ended on January 17, saw 53% price cuts on average of the 32 drugs that treat diseases including cancer and type II diabetes. 22 January 2020
Biotechnology
According to the UK’s health technology assessor, German pharma major Bayer’s Vitrakvi (larotrectinib), a new treatment for a range of cancers, can’t be recommended for use in the National Health Service (NHS) because at its current price, it doesn’t have the potential to be cost-effective. 20 January 2020
Generics
India’ National Pharmaceutical Pricing Authority has allowed both Cipla and Glenmark Pharma to enhance pricing for two of their respiratory products after they were termed innovative compared to other similar products available in the market. 17 January 2020
Biotechnology
The BioMarin hemophilia A gene therapy Valrox (valoctocogene roxaparvovec) could become the world’s priciest drug, it is being reported. 17 January 2020
Pharmaceutical
The Hungarian government’s health department has decided to include 26 new medicinal products and indications into the subsidy system, affecting several therapeutic fields, announced Miklós Kásler, Minister of Human Capacities. 17 January 2020
Biotechnology
A document from the National Institute for Health and Care Excellent (NICE) has not recommended Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumors express PD-L1 with a combined positive score of one or more. 15 January 2020
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