Pricing, reimbursement and access
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Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended the use of Revlimid (lenalidomide) as maintenance treatment after an autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma in adults. 27 January 2021
Pharmaceutical
The UK’s pricing and reimbursement agency has delivered a negative verdict on Bristol Myers Squibb’s novel multiple sclerosis drug, Zeposia (ozanimod). 25 January 2021
Pharmaceutical
The US Senate Finance Committee has released a new report detailing findings of its investigation into the role that market dynamics play in the pricing of insulins. 25 January 2021
Biotechnology
An assessment is underway to decide the comparative clinical effectiveness and value for the US market of Aurinia Pharmaceuticals’ voclosporin and GlaxoSmithKline’s Benlysta (belimumab) for the treatment of lupus nephritis (LN). 22 January 2021
Biotechnology
The Institute for Clinical and Economic Review (ICER) has published an evidence report on new therapies for treating high cholesterol. 22 January 2021
Biotechnology
The National Institute for Health and Care Excellence (NICE) has published a final appraisal determination (FAD) recommending the use of the daily oral pill Jyseleca (filgotinib) on the National Health Service (NHS) in England for moderate to severe active rheumatoid arthritis (RA). 21 January 2021
Pharmaceutical
Anglo-Irish rare diseases specialist Amryt Pharma (LSE: AMYT) has won a positive reimbursement decision in the UK for Myalepta (metreleptin). 20 January 2021
Biotechnology
Chinese biotechs must keep their eyes on markets outside China if they want to survive and thrive, said speakers at the China Biomed conference held online on January 12. 19 January 2021
Biotechnology
From today National Health Service (NHS) clinicians in England will be able to consider the treatment for some patients with a form of lymphoma, a cancer that attacks the immune system, according to UK health technology assessor the National Institute for Health and Care Access (NICE). 19 January 2021
Pharmaceutical
Several Indian pharmaceutical companies have been accused of overcharging consumers. 18 January 2021
Generics
Highlighting over-medication as a potential hazard while also flagging the prospect of 'profiteering' by drug companies, India's drug price watchdog the National Pharmaceutical Pricing Authority (NPPA) has expressed concern about the many drug cocktail applications that continue to flood its office as also those that are surreptitiously available in the country, reports The Pharma Letter’s India correspondent. 18 January 2021
Biotechnology
US trade group the Pharmaceutical Research and Manufacturers of America (PhRMA) has pointed out the savings that gene therapies can deliver for patients that otherwise require lifelong treatment. 18 January 2021
Pharmaceutical
The US Department of Justice collected more than $2.2 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2020, Acting Assistant Attorney General Jeffrey Bossert Clark of the Department of Justice’s Civil Division announced yesterday. 15 January 2021
Pharmaceutical
The UK’s health technology assessor, the National Institute for Health and Care Excellence (NICE), today issued a final appraisal determination (FAD) recommending the use of Zejula (niraparib) on the National Health Service NHS in England for adult women with advanced high-grade epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, who have completed and shown a response to platinum-based chemotherapy. 15 January 2021
Pharmaceutical
US campaign group Patients For Affordable Drugs has highlighted price increases that took effect this month. 14 January 2021
Biotechnology
US biotech Checkpoint Therapeutics says it is moving along in its quest to disrupt the ~$25 billion+ immunotherapy market with its anti-PD-L1, cosibelimab, and could be in a position do so as soon as 2022. 13 January 2021
Pharmaceutical
The latest report on Unsupported Price Increases (UPI) of prescription drugs in the USA has been published by the Institute for Clinical and Economic Review (ICER). 12 January 2021
Biotechnology
US biotech EQRx, which is committed to developing and delivering important new medicines at lower prices, today announced that it has raised $500 million in Series B financing. 11 January 2021
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) recommending Forxiga (dapagliflozin) for symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults, as an add-on to optimised standard care. 7 January 2021
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has formally launched the Innovative Licensing and Access Pathway (ILAP). 4 January 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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