Pricing, reimbursement and access
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Pharmaceutical
In the UK, a positive reimbursement decision has paved the way for certain people with advanced thyroid cancer to receive treatment with Eli Lilly’s Retsevmo (selpercatinib). 1 October 2021
Biotechnology
The World Health Organization (WHO) has recommended the addition of another therapeutic – Ronapreve (casirivimab and imdevimab; known as REGEN-COV in the USA) - to the world’s arsenal against COVID-19, but urges producing companies and governments to address the high price and limited production of the antibody combination and ensure safe and appropriate handling of the medicine. 27 September 2021
Biosimilars
The USA’s Association for Accessible Medicines (AAM), the trade body for generic and biosimilar manufacturers, has released the top-line findings from its forthcoming 2021 Generic Drug and Biosimilars Savings in the US report highlighting the value of generic and biosimilar drugs. 27 September 2021
Pharmaceutical
Making the prices of medicines more transparent around the world would appear to be a positive force for patients. 21 September 2021
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended Keytruda (pembrolizumab) in an indication for which it won UK approval just two months ago. 17 September 2021
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in an early benefit of AbbVie and Roche’s Venclexta/Venclexto (venetoclax) in combination with a hypomethylating agent (HMA) offers an added benefit over the appropriate comparator therapy for patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. 17 September 2021
Biotechnology
Orladeyo (berotralstat) is to be made available on the National Health Service (NHS) for hereditary angioedema (HAE) patients in England, Wales and Northern Ireland, the UK’s National Institute for Health and Care Excellence (NICE) has recommended. 16 September 2021
Biotechnology
Cambridge, USA-based EQRx, a biotech firm focused on developing lower-cost innovative medicines, has announced new data from a trial of its lung cancer candidate, sugemalimab. 15 September 2021
Generics
Prices of key anti-diabetes, cancer and tuberculosis drugs manufactured by Sanofi (Euronext: SAN), Glenmark Pharmaceuticals (BSE: 532296) and Zydus Cadila, among other companies in India, are set to get cheaper. Antiviral and antibacterial drugs, antiretroviral drugs, and drugs used in COVID-19 treatment are also set to become more affordable. 15 September 2021
Pharmaceutical
Prices for brand-name drugs in particular are higher in the USA compared with other high-income countries, most of which regulate drug prices. However, inconsistent availability of data on net prices (ie, prices after rebates and other discounts) complicates international comparisons of drug prices, according to new research. 13 September 2021
Biotechnology
The Institute for Clinical and Economic Review (ICER) has released its revised Evidence Report assessing the comparative clinical effectiveness and value of two generalized myasthenia gravis (gMG) drugs. 10 September 2021
Biotechnology
Today’s news of the licensing of Trodelvy (sacituzumab govitecan) brings little comfort to women with triple negative incurable secondary breast cancer, as the drug’s developer, company Gilead Sciences (Nasdaq: GILD), failed to reach an agreement with NHS England to provide the drug free-of-charge to eligible patients, ahead of a National Institute for Health cand Care Excellence (NICE) decision on routine National Health Service (NHS) access next year, says the charity Breast Cancer Now. 10 September 2021
Pharmaceutical
US Health and Human Services (HHS) Secretary Xavier Becerra yesterday unveiled a comprehensive plan to lower drug prices as part of a long-awaited report from the HHS to the White House that offers a wide-ranging series of recommendations on curbing rising drug costs 10 September 2021
Biotechnology
The UK’s health technology assessor has agreed to an early access scheme for Amgen’s sotorasib, the first approved targeted therapy for tumors with any KRAS mutation. 10 September 2021
Pharmaceutical
South Korea has recently decided to provide practical support to innovative pharmaceutical companies by revising the existing health insurance benefits system. 8 September 2021
Pharmaceutical
The UK health technology assessor the National Institute of Health and Care Excellence (NICE) has reconsidered its previous decision for Erleada (apalutamide). 8 September 2021
Pharmaceutical
Medicines Australia, the leading trade group for the biotech and pharma industries in the country, has helped negotiate a five-year strategic plan with the national government. 7 September 2021
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended Cosentyx (secukinumab) as an option for treating moderate to severe plaque psoriasis in people aged six to 17 years who have not responded to other forms of systemic treatment or for whom these options were contraindicated or not tolerated. 6 September 2021
Pharmaceutical
Humanitarian organization Médecins Sans Frontières (MSF) has highlighted the World Health Organization’s (WHO) new rapid guidance recommending that children of all ages with drug-resistant tuberculosis (DR-TB) have access to all-oral treatment using the drugs bedaquiline and/or delamanid. 3 September 2021
Biotechnology
GlaxoSmithKline has launched its shingles vaccine, Shingrix (zoster vaccine recombinant), in the UK. The vaccine will be available to purchase from pharmacies and private healthcare practices, as well as through a national immunization program for people in their seventies. 1 September 2021
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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