Pricing, reimbursement and access
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Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has decided not to recommend Xenpozyme (olipudase alfa) as a treatment for acid sphingomyelinase deficiency (ASMD; Niemann-Pick Disease) in people with type AB or type B. 5 March 2024
Pharmaceutical
All manufacturers participating in the first cycle of the US Medicare drug price negotiations have responded with counter offers, according to the US Department of Health and Human Services’ (HHS) Centers for Medicare and Medicaid Services (CMS). 5 March 2024
Biotechnology
UK health technology assessor the National Institute for for Health and Care Excellence (NICE) today issued a final draft guidance recommending UK pharma major GSK’s Jemperli (dostarlimab) for a new indication. 5 March 2024
Pharmaceutical
Privately-held company GAIA has announced an update on klariva, an innovative digital therapeutic (DTx). 5 March 2024
Pharmaceutical
In another legal blow for opponents of the Inflation Reduction Act (IRA), a federal judge has now rejected a bid from AstraZeneca to prevent price negotiations on its diabetes med Farxiga (dapagliflozin). 4 March 2024
Biotechnology
There is a ray of hope for sickle cell disease (SCD) patients in the UK, after the British health technology assessor re-opened its review into Oxbryta (voxelotor). 1 March 2024
Pharmaceutical
In the USA, there is growing resistance to a bid from the White House to exercise so-called march-in rights, a process whereby the federal government requires patent holders to agree to a licence. 27 February 2024
Biotechnology
A new partnership will see Japanese pharma major Takeda and India’s Biological E (BE) working together to accelerate access to Qdenga (dengue vaccine). 27 February 2024
Biotechnology
On Friday, the US Food and Drug Administration (FDA) announced its final decision to withdraw the marketing authorization of Swedish biotech Oncopeptides’ Pepaxto (melphalan flufenamide). 24 February 2024
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published Final Draft Guidance which recommends US pharma giant Pfizer’s Litfulo (ritlecitinib). 22 February 2024
Biosimilars
The US Department of Veterans Affairs (VA) has exclusively selected Organon's Hadlima in replacement of Humira (adalimumab) for the VA National Formulary. 21 February 2024
Generics
Reform of the procurement policies applied to generic medicines is needed to ensure greater security of supply for patients and health systems, according to Medicines for Europe. 19 February 2024
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has issued a Final Draft Guidance (FDG) recommending GSK’s Omjjara (momelotinib) for myelofibrosis-related splenomegaly or symptoms in adults with moderate to severe anaemia who have not had a JAK-inhibitor or had Jakafi (ruxolitinib). 15 February 2024
Generics
The USA’s Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) yesterday jointly issued a Request for Information to understand how the practices of two types of pharmaceutical drug middlemen groups - group purchasing organizations (GPOs) and drug wholesalers - may be contributing to generic drug shortages. 15 February 2024
Biotechnology
French pharma major Sanofi is angry that its interleukin (IL)-13 and IL-4 blocking antibody Dupixent (dupilumab) has been recommended for the treatment of moderate-to-severe prurigo nodularis (PN) in Scotland but not in England and Wales. 14 February 2024
Pharmaceutical
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has made clear its opposition to the drug price-setting provisions in the Biden administration’s Inflation Reduction Act (IRA). 14 February 2024
Generics
Non-governmental organization Médecins Sans Frontières (MSF) has issued a warning about the details of a trade deal that is about to be agreed by India and the European Free Trade Association (EFTA). 14 February 2024
Pharmaceutical
The USA’s Federal Trade Commission yesterday issued a comment in response to the National Institute of Standards and Technology’s (NIST) request for information on its Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights under the Bayh-Dole Act. 7 February 2024
Generics
The share of cheap drugs in the Russian pharmaceutical market is steadily declining, while in the last three years their overall range in the market has declined two-fold, reports The Pharma Letter’s local correspondent. 7 February 2024
Pharmaceutical
An Expert View from Ross Maclean, Precision Health Economics, Outcomes Research and Head of Medical Affairs,
Precision Value and Health, and the same company's Jon Bambalas, Senior Vice President Business Development, Products Senior Vice President Business Development. 5 February 2024
Pharmaceutical
Swiss pharma major Roche likes the idea of direct-to-patient sales in the USA. 25 July 2025
Generics
Hospitals are rationing cancer treatments. Pharmacies are scrambling to fill routine antibiotic prescriptions. And across the USA, patients are facing growing delays, substitutions, or outright denials of essential medicines, not because the drugs don’t exist, but because the supply chains behind them have buckled. 24 July 2025
Generics
A new report has drawn attention to the growing number of prescription drugs being excluded from commercial insurance formularies in the USA—particularly affordable generics and biosimilars—raising fresh concerns over patient access and out-of-pocket costs. 24 July 2025
Biotechnology
The race to develop effective cancer vaccines has entered a new phase, with late-stage trials from companies like Moderna and BioNTech generating momentum and sharpening investor focus. 23 July 2025
Pharmaceutical
Denmark-based allergy immunotherapy specialist ALK Abello today announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of the company’s tree pollen tablet Itulazax for the treatment in adults. 21 July 2025
Biotechnology
The Institute for Clinical and Economic Review (ICER) has cast doubt on the value of a new spinal muscular atrophy treatment from US biotech Scholar Rock, while reaffirming concerns about limited comparative data across the class of SMA therapies. 18 July 2025
Pharmaceutical
The Bristol Myers Squibb-Pfizer Alliance today announced a new direct-to-patient option for purchasing Eliquis (apixaban) via their Alliance’s patient resource Eliquis 360 Support. 17 July 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Novartis’ Kisqali (ribociclib) as an adjuvant treatment for all eligible populations of HR+/HER2- early breast cancer patients. 17 July 2025
Pharmaceutical
The UK government’s new life sciences plan has been met with skepticism by the pharmaceutical industry, which says the strategy will fall flat unless there is a serious shift in the way new medicines are funded and valued. 16 July 2025
Biotechnology
The US regulator has launched a new national initiative to help Medicaid programs fund gene therapies for sickle cell disease, under an agreement aimed at broadening access while linking payments to real-world treatment results. 16 July 2025
Biotechnology
The USA's Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of Sanofi’s tolebrutinib for the treatment of secondary progressive multiple sclerosis (SPMS). 15 July 2025
Pharmaceutical
In the USA, the 340B hospital markup program cost state and federal taxpayers an estimated $6.5 billion per year due to lost Medicaid rebates, according to a new report from Berkeley Research Group (BRG). 15 July 2025
Pharmaceutical
US biotech major Vertex Pharmaceuticals has reached a wide-ranging reimbursement deal with NHS England for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), a next-generation oral therapy for cystic fibrosis (CF), clearing the way for access to thousands of eligible patients across the country. 15 July 2025
Biotechnology
A quiet shift with potentially big implications for cancer drug access is underway in the UK. In June, the country’s health technology assessor, NICE, recommended GSK’s Blenrep (belantamab mafodotin) in multiple myeloma. 14 July 2025
Pharmaceutical
China’s vaccine landscape is shifting after local biotech Xiamen Innovax Biotech unveiled the country’s first domestically developed nine-valent HPV vaccine, Cecolin 9, at a price far below that of the incumbent Gardasil 9. The new shot is being offered at around $70 per dose—less than half the typical price of Merck & Co’s (NYSE: MRK) product in the country. 14 July 2025
Biosimilars
South Korea’s Samsung Bioepis today published a whitepaper titled ‘Solving the Biosimilar Void in Europe’ that proposes policy recommendations to fully recognize the value of biosimilars and ensure a more sustainable market in Europe. 14 July 2025
Pharmaceutical
New figures in Danish pharma trade group Lif's Medicine Reimbursement Meter show a slight increase in the number of pharmacy medicines for which companies applied for reimbursement in 2024 - and the development for 2025 is positive. 14 July 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has published final guidance recommending Eli Lilly’s Omvoh (mirikizumab) for use on the National Health Service (NHS) in England and Wales as an option for moderately to severely active Crohn’s disease in adults. 11 July 2025
Biotechnology
BeOne Medicines - the Sino-American oncology specialist formerly known as BeiGene - has announced that the National Institute for Health and Care Excellence (NICE) has recommended Brukinsa (zanubrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL) after one line of treatment. 10 July 2025
Biotechnology
Japanese authorities are putting Eisai under pressure to reconsider the price of its Alzheimer’s disease therapy Leqembi (lecanemab), after a government-backed review found that the drug significantly exceeds accepted cost-effectiveness thresholds in the country. 10 July 2025
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