Pricing, reimbursement and access
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Biotechnology
US biotech Gilead Sciences has announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of Trodelvy (sacituzumab govitecan) in England within its marketing authorization. 14 July 2022
Biosimilars
Market expansion services provider DKSH has partnered with life cycle management company Pharmanovia, to bring high-quality pharmaceutical products to patients across the Asia Pacific. 11 July 2022
Biotechnology
The UK’s pricing and reimbursement agency, the National Institute for Health and Care Excellence (NICE), has issued its verdict on new atopic dermatitis treatments. 5 July 2022
Pharmaceutical
French pharma major Sanofi has launched a new non-profit project designed to help at-risk populations in the world’s least developed countries. 4 July 2022
Pharmaceutical
Effective July 1, uninsured people living with diabetes in the USA be able to obtain one or multiple Sanofi insulins from the French pharma major’s Insulins Valyou Savings Program with a valid prescription for a total of $35 for a 30-day supply. Previously, the program offered a 30-day supply of Sanofi insulins for $99. 30 June 2022
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document recommending Rinvoq (upadacitinib), from US drugmaker AbbVie, as a treatment of moderate to severe atopic dermatitis (AD) for adults and young people aged 12 and over. 29 June 2022
Pharmaceutical
Russia is reducing procurements of expensive Western original drugs for the treatment of HIV, switching to cheaper medicines, due to the lack of funds and the ever-growing number of patients with HIV in the country, reports The Pharma Letter’s local correspondent. 28 June 2022
Pharmaceutical
National Health Service England and Improvement (NHSE/I) has announced the launch of the Innovative Medicines Fund (IMF), aimed at providing earlier access to certain promising new drugs while additional evidence is generated about their use. 27 June 2022
Pharmaceutical
Serum Institute of India’s (SII) Cervavac - a quadrivalent human papillomavirus (qHPV) vaccine - is likely to be the first indigenous qHPV vaccine to be approved in India. 23 June 2022
Pharmaceutical
The continuous depreciation of the forint, the pandemic, and then the war in Ukraine has seriously endangered safe access to modern medicinal treatments, which is now exacerbated by the disproportionate and high special tax increase that may lead to unforeseen consequences, says the Hungarian pharma trade group Association of Innovative Pharmaceutical Manufacturers (AIPM). 20 June 2022
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has recommended abemaciclib in combination with endocrine therapy, within its marketing authorization, as an option for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer in adults whose disease is at high risk of recurrence, defined as pathological tumor involvement in: 17 June 2022
Pharmaceutical
Japanese drugmaker Shionogi has signed an agreement with the National Health Service (NHS) to begin an innovative subscription payment model reimbursement of cefiderocol in England. 15 June 2022
Pharmaceutical
Shares of Japanese drug major Shionogi closed down 5.6% at 6,493 yen today, despite revealing what it described as a “landmark” collaboration for access to its antibiotic cefiderocol, which is marketed under the trade name Fetroja. 15 June 2022
Pharmaceutical
A couple of European interest groups have issued a joint statement on patient access to medicines for rare diseases. 15 June 2022
Biotechnology
The first CAR-T cell therapy to treat cancers of the blood and lymphatic system is to be available in India early next year, offering hope to patients who can’t afford to travel abroad for the expensive treatment. 14 June 2022
Pharmaceutical
Nearly half a million people in England and Wales at serious risk of a secondary and possibly fatal cardiovascular event, such as a stroke or heart attack, could benefit from a new treatment following a recommendation from the UK’s health technology assessor. 10 June 2022
Pharmaceutical
The annual Prescription Cost Analysis (PCA) includes information about the costs and volumes of prescriptions that have been dispensed under the National Health Service (NHS) in England. 9 June 2022
Pharmaceutical
The UK subsidiary of Japan’s Astellas Pharma says that the National Institute for Health and Care Excellence (NICE) has recommended Evrenzo (roxadustat), as an option for treating symptomatic anemia associated with chronic kidney disease (CKD) in adults with stage 3 to 5 CKD with no iron deficiency and are not on dialysis at the start of treatment. 9 June 2022
Pharmaceutical
In the face of surging drug prices in the USA, the Federal Trade Commission announced on Tuesday that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers (PBMs) to provide information and records regarding their business practices. 8 June 2022
Pharmaceutical
The UK subsidiary of Japan’s Takeda today announced that the National Institute for Health and Care Excellence (NICE) has published its Final Appraisal Document (FAD) recommending Revestive (teduglutide) once daily subcutaneous injection as an option for people living with short bowel syndrome (SBS) aged one year and above. 6 June 2022
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
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