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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has recommended Rinvoq (upadacitinib) for moderately to severely active ulcerative colitis (UC) when conventional or biologic treatment is not working or cannot be tolerated. 25 November 2022
Biotechnology
The British reimbursement agency, the National Institute for Health and Care Excellence (NICE), has provided a positive recommendation for an Opdivo (nivolumab) combination therapy. 25 November 2022
Biotechnology
In a landmark regulatory first, Dutch gene therapy company uniQure (Nasdaq: QURE) has secured US approval for its one-time hemophilia B treatment, Hemgenix (etranacogene dezaparvovec-drlb). 23 November 2022
Pharmaceutical
Representatives of the Russian patient community have warned about the shortage of the antiretroviral drug Eviplera (rilpivirine/tenofovir/emtricitabine), the most popular and most expensive combination drug for the treatment of HIV on the domestic market, reports The Pharma Letter’s local correspondent. 22 November 2022
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended Exkivity (mobocertinib) for treating EGFR Exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy within a Final Appraisal Document (FAD). 18 November 2022
Pharmaceutical
Today, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) – the expert committee that evaluates the value of medicines in in the country – published advice recommending Australia’s discount rate could be lowered between 3.5% - 4% to bring the country closer to other recommended international standards. This is down from the current 5%. 18 November 2022
Biosimilars
Access to therapies used to treat major chronic diseases remains particularly limited in Central and Eastern Europe (CEE). Off patent medicines are often the first opportunity for patients to access the essential medicines they need, says Medicines for Europe, the trade body representing bakers of biosimilar and generic drugs. 16 November 2022
Biotechnology
In a draft recommendation, the UK’s reimbursement agency has found in favor of three COVID-19 treatments, while sidelining several others. 16 November 2022
Generics
As Indian drugmakers cry foul on not receiving an appropriate "incentive for incremental innovation," the government and the domestic pharmaceutical industry are to sit together to iron out the kinks on a pricing mechanism for drugs that are going off patent, reports The Pharma Letter’s India correspondent. 15 November 2022
Pharmaceutical
The demand for insulin in Russia is steadily growing, which provides some opportunities for global majors operating in this market segment, reports The Pharma Letter’s local correspondent. 15 November 2022
Biotechnology
A dose of reality appears to have brought about a change at EQRx. 11 November 2022
Biotechnology
Boston, USA-based pricing watchdog The Institute for Clinical and Economic Review (ICER) has published an evidence report on the comparative clinical effectiveness of hemophilia treatments. 2 November 2022
Pharmaceutical
According to the Russian pharma trade body the ARPM, the 2nd Annual “Right to Health” Congress was held in Moscow, aimed to highlight the prospects of the domestic healthcare industry, which have become more acute in modern geopolitical conditions, in a wide format. 26 October 2022
Pharmaceutical
The UK's National Institute for Health and Care Excellence (NICE) has recommended the use of Ryeqo (relugolix/estradiol/norethisterone) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. 24 October 2022
Pharmaceutical
In August, the UK’s Medicines and Healthcare Regulatory Agency (MHRA) approved Sunlenca (lenacapavir) injection and tablets, alongside other antiretrovirals, in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. 21 October 2022
Pharmaceutical
Boston, Massachusetts-based non-profit The Institute for Clinical and Economic Review (ICER) has issued its final report into the cost-effectiveness of the latest generation of weight loss treatments. 21 October 2022
Biotechnology
Spanish plasma-derived medicines company Grifols ( today announced that its drug Tavlesse (fostamatinib) has a been recommended by UK health technology assessor the National Institute for Health and Care Excellence (NICE) to treat chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments. 19 October 2022
Biosimilars
US biotech major Amgen, which also has a significant presence in the biosimilar medicines sector, has released the 9th edition of its Biosimilar Trends Report, which examines the current and future state of the US marketplace with biosimilars. 17 October 2022
Generics
Mumbai, India-based generic drugmaker Lupin Limited revealed that it has reached an agreement with Unitaid, the Aurum Institute, the Clinton Health Access Initiative (CHAI), and other global procurement agencies to support tuberculosis (TB) prevention treatment that will be rolled out to 138 countries, including many low-and middle-income countries with a large burden of TB. 17 October 2022
Pharmaceutical
The migraine market has seen the introduction of a large number of highly effective monoclonal antibody (Mab) drugs for the prevention of the condition, leading to expectations for the overall therapy sector to grow from $4.7 billion in 2020 to $12 billion in 2030 across the seven major markets. 13 October 2022
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