Pricing, reimbursement and access
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Pharmaceutical
A controversial proposal to change the Inflation Reduction Act’s pricing framework for rare disease drugs has been dropped from the Senate’s reconciliation package, marking a win for patient advocacy groups that lobbied against it. The ORPHAN Cures Act, which sought to shield some rare disease drugs from Medicare price talks, was notably absent from the text released this week by the Senate Finance Committee. 18 June 2025
Pharmaceutical
US trade association PhRMA (Pharmaceutical Research and Manufacturers of America) has cited a new IQVIA study that found that Medicare Part D plans routinely deny access to prescribed medicines for patients with newly-diagnosed chronic conditions. 17 June 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
Biotechnology
Africa is grappling with a worsening mpox crisis, with a critical shortfall of vaccine doses threatening to derail containment efforts. Public health leaders are warning that the scarcity is exacerbating the spread of the virus, even as the World Health Organization (WHO) maintains that mpox remains a public health emergency of international concern. 10 June 2025
Pharmaceutical
A sweeping legislative package backed by US President Donald Trump could strip health insurance from more than 16 million Americans over the next decade, according to a new analysis from the Congressional Budget Office. 5 June 2025
Pharmaceutical
The NHS Business Services Authority (NHSBSA) has published the annual Prescription Cost Analysis (PCA) for 2024/25. 5 June 2025
Pharmaceutical
Sogroya (somapacitan injection) has been recommended by UK health technology assessor the National Institute for Health and Care Excellence (NICE) as a treatment for people aged 3 to 17 years with pediatric growth hormone deficiency, the UK subsidiary of Denmark’s Novo Nordisk revealed yesterday. 4 June 2025
Pharmaceutical
The UK risks losing £11 billion ($14 billion) in pharmaceutical R&D investment by 2033 unless urgent reforms are made to high and unpredictable clawback payments imposed on medicine sales to the National Health Service, according to a new report commissioned by the Association of the British Pharmaceutical Industry (ABPI). 3 June 2025
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published updated Final Draft Guidance recommending Forxiga (dapagliflozin) as an option to treat chronic kidney disease in adults, AstraZeneca announced today. 30 May 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that Filspari (sparsentan) can be used in the National Health Service (NHS) in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0g/day or more, or a urine protein-to-creatinine ratio of 0.75g/g or more. 23 May 2025
Pharmaceutical
A week after US President Donald Trump signed an executive order to bring back the Most Favored Nation (MFN) idea he introduced at the end of his first term, the US Department of Health and Human Services (HHS announced it is proceeding with implementing the order on prescription drug pricing. 20 May 2025
Pharmaceutical
A US district court judge has found that the Department of Health and Human Services (HHS) must preapprove the use of 340B rebate models before they can be implemented. 19 May 2025
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released new data that sheds light on why patients in some European countries wait significantly longer than others for access to innovative medicines. 19 May 2025
Biotechnology
The Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec for the treatment of advanced retinitis pigmentosa. 16 May 2025
Pharmaceutical
US President Donald Trump released an executive order on May 12 calling for a 30-day negotiation period between the Department of Health and Human Services (HHS) and the biopharma industry, with the threat of a rule from the Centers for Medicare and Medicaid Services (CMS) to lower US drug prices if no deal is reached. 14 May 2025
Pharmaceutical
US pharma stocks regained ground Monday after Donald Trump signed an executive order aiming to slash prescription drug prices, a move that initially rattled investors but left many analysts unconvinced about its impact. 13 May 2025
Pharmaceutical
US President Donald Trump sent shivers through the pharmaceutical industry as he vowed to dramatically reduce the high drug prices that have long been a feature of the US market. 12 May 2025
Pharmaceutical
New figures from European industry group EFPIA paint a stark picture of the growing divide in access to innovative medicines across the EU, with patients in some countries waiting more than seven times longer than others for the same treatment. 12 May 2025
Pharmaceutical
UK pharma major AstraZeneca has suffered a setback in its legal fight to block the US government's efforts to lower prescription drug prices, after a federal appeals court dismissed its challenge to Medicare’s negotiation powers. 9 May 2025
Pharmaceutical
The introduction of outpatient flat-rate payments approved today by the Swiss Federal Council poses significant risks for patients and for the pharmaceutical industry as a whole. Including medication costs in flat-rate payments creates a dangerous perverse incentive to treat patients with the cheapest rather than the most suitable medications, according to a website posting by Interpharma. 5 May 2025
Biotechnology
The UK’s health technology assessor has changed its tune regarding CSL Behring’s Hemgenix (etranacogene dezaparvovec), recommending the product for use in England and Wales. 27 June 2024
Pharmaceutical
London-based pharma major GSK—one of the UK’s flagship companies—has suffered a galling defeat on home soil to US rival Pfizer. 25 June 2024
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has approved Crysvita (burosumab) from Japanese drugmaker Kyowa Kirin. 21 June 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended Eladynos (abaloparatide). 21 June 2024
Biotechnology
Sanofi today revealed that UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued final draft guidance (FDG) not recommending Sarclisa (isatuximab) plus pomalidomide and dexamethasone (Isa-Pd), within its marketing authorization 20 June 2024
Pharmaceutical
Johnson & Johnson says it has “grave concern” for the availability of future innovative mental health treatments in England, following a decision by National Institute for Health and Care Excellence (NICE) to not re-appraise Spravato (esketamine nasal spray) for treatment-resistant depression in England 13 June 2024
Pharmaceutical
US Senator Bernie Sanders, chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), has announced that members will vote next week on whether to subpoena Doug Langa, senior vice president, head of North America operations and president of Novo Nordisk. 12 June 2024
Pharmaceutical
Russia is sharply cutting centralized state purchases of anti-HIV drugs due to the problems with funding and the reduction of supplies to Russia by global drugmakers, reports The Pharma Letter’s local correspondent. 12 June 2024
Biosimilars
As more biologics drugs lose their patent protection, the influx of biosimilars is set to expand, offering cost-effective alternatives and significantly impacting their respective markets. 5 June 2024
Pharmaceutical
Last week, the US Court of Appeals for the District of Columbia (DC) ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program, noted Sophia Gaulkin and Alan Kirschenbaum of law firm Hyman Phelps & McNamara. 1 June 2024
Biosimilars
Chief Executive Officers of the world’s largest generic and biosimilar medicines companies recently met in Vienna, Austria, to provide strategic advice to the International Generic and Biosimilar Medicines Association (IGBA). 29 May 2024
Pharmaceutical
French pharma trade group Leem (Les Entreprises du Medicament) has published its annual survey on the taxation of the pharmaceutical industry, compared to that of other European countries. 28 May 2024
Generics
UK-based Alliance Pharma (AIM: APH) has successfully appealed against a Competition and Markets Authority (CMA) ruling that had found the company guilty of breaching competition law. 24 May 2024
Pharmaceutical
The US National Institutes of Health (NIH) has issued a first-of-its-kind draft policy proposal to promote equal access to products stemming from NIH-owned inventions. 23 May 2024
Pharmaceutical
Rhythm Pharmaceuticals, a US biopharma specializing in rare neuroendocrine diseases, has announced that its drug Imcivree (setmelanotide) is expected to be funded and available for use in England and Wales within three months through the National Health Service (NHS) in specialist centers. 22 May 2024
Pharmaceutical
A US Food and Drug Administration (FDA) panel will consider Lykos Therapeutics’ filing for midomafetamine capsules (MDMA) as a therapy-assisted treatment for post-traumatic stress disorder (PTSD) in early June. 15 May 2024
Biotechnology
Overall spending in the US market for medicines grew by 2.5% and reached $435 billion in 2023. 15 May 2024
Pharmaceutical
Four-year data from the SELECT trial will significantly bolster Novo Nordisk’s bid to become the GLP-1 company of choice for payers and prescribers. 15 May 2024
Pharmaceutical
A new study by diabetes awareness website Diabetes Strong reveals that “How to get Ozempic” is the most googled question about the medication. 14 May 2024
Biosimilars
The US unit of South Korea’s Celltrion announced that adalimumab-aaty, the company's high-concentration (100 mg/mL) and citrate-free formulation biosimilar to Humira (adalimumab), is now available at a low wholesale acquisition cost (WAC). 13 May 2024
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