Pricing, reimbursement and access
Refine Search
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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has unleashed a broadside against decision-makers in Brussels. 15 March 2023
Pharmaceutical
An Expert View from the global consulting firm CRA's Steve Kelly, Mike Hodder and Owen Jones. 15 March 2023
Generics
Attempts to curb drug shortages in Germany may not be sufficient to prevent a crisis, the government has been warned. 14 March 2023
Pharmaceutical
Two American firms have agreed terms for the joint commercialization of the novel attention deficit/hyperactivity disorder (ADHD) candidate CTx-1301 (dexmethylphenidate). 13 March 2023
Pharmaceutical
Spanish privately owned drugmaker Esteve says it has now obtained pricing and financing for an inhaled treatment for OFF periods in Parkinson's disease, which it launched on the Spanish market in mid-February 2023. 11 March 2023
Pharmaceutical
Despite strong protest from the UK pharmaceutical sector, including several companies quitting the scheme, the government has confirmed plans to raise the revenue clawback rate paid by firms subject to the Statutory Scheme for branded medicines from 24.4% to 27.5%. 3 March 2023
Pharmaceutical
Following in the steps of other big insulin producers, US pharma major Eli Lilly yesterday announced price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 0or less per month. 2 March 2023
Biotechnology
The influential Institute for Clinical and Economic Review (ICER), a Boston, USA-based pricing watchdog, has released a report into the cost-effectiveness of Leqembi (lecanemab). 1 March 2023
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI) has attempted to show that there is a better way than the existing Voluntary Pricing and Access Scheme (VPAS). 1 March 2023
Biosimilars
The need to guarantee a new regulatory category for ‘value-added medicines’ has been proposed by the Asociación Española de Medicamentos Genéricos (AESEG), the Spanish trade group representing generic and biosimilar medicine manufacturers. 27 February 2023
Pharmaceutical
Minister for Health Stephen Donnelly’s decision to publish the Mazars Report has been welcomed by the Irish Pharmaceutical Healthcare Association (IPHA). 27 February 2023
Biotechnology
Pfizer has already reported eye-watering annual revenue of $100.3 billion for 2022 driven by its products related to the COVID-19 pandemic, notably the Comirnaty vaccine, which witnessed a record demand last year with forecast sales of $37 billion. 24 February 2023
Biotechnology
A final evidence report from the Institute for Clinical and Economic Review (ICER) on the affordability of multiple sclerosis (MS) drugs in the USA has found that monoclonal antibodies (MAbs) do not offer value for money at current prices. 22 February 2023
Biotechnology
The European Commission has granted conditional marketing authorization (CMA) for Hemgenix (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors. 21 February 2023
Generics
Patients in India suffering from cystic fibrosis are petitioning the Indian government to allow generic versions of Vertex Pharmaceuticals’ (Nasdaq: VRTX) Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) and Orkambi (lumacaftor/ivacaftor). 17 February 2023
Pharmaceutical
The Secretary of the US Department of Health and Human Services (HHS) has selected three new models for testing by the Centers for Medicare & Medicaid Services’ (CMS) Innovation Center to help lower the high cost of medicines in the USA. 15 February 2023
Pharmaceutical
The range medicines available in Russian pharmacies is steadily declining, which is mainly due to tough economic environment in the country, caused by Western sanctions and the existing problems with logistics, reports The Pharma Letter’s local correspondent. 14 February 2023
Pharmaceutical
In the USA, the Department of Health and Human Services (HHS) has released its initial guidance for the implementation of a rebate program capping the price of certain medications provided under the Medicare insurance program. 10 February 2023
Pharmaceutical
UK medicines cost watchdog the National Institute for Health and Care Excellence (NICE) has recommended Stivarga (regorafenib), from German pharma major Bayer, as a treatment option for adult patients with metastatic colorectal cancer who have had previous treatment (including fluoropyrimidine-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy) or when these treatments are unsuitable. 10 February 2023
Biotechnology
French drugmaker Sanofi has announced the availability of its new Pompe disease drug Nexviadyme (avalglucosidase alfa) on the UK’s National Health Service (NHS). 8 February 2023
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze