Pricing, reimbursement and access
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Pharmaceutical
US Senator Cory Booker (Democrat, New Jersey) on Friday announced legislation to systemically change the way prescription drugs are priced in order to reduce drug costs for Americans and increase access to the medications they need, with Senators Bernie Sanders (Independent, Vermont) and Kamala Harris (Democrat, California) joining him as original co-sponsors. 18 November 2019
Generics
Medicines for Europe and APOGEN have this week held an Open Industry Day in Portugal to showcase the quality and safety of generic, biosimilar and value-added medicines production in Europe and to discuss current and future market challenges. 15 November 2019
Pharmaceutical
A new analysis from researchers at West Health Policy Center and Johns Hopkins Bloomberg School of Public Health reveals high levels of profitability among large drugmakers. 14 November 2019
Pharmaceutical
The list price of drugs prescribed on the UK’s National Health Service (NHS) has been published for the year 2018-19. 14 November 2019
Pharmaceutical
Following publication this week of the IQVIA report Assessing Person-Centered Therapeutic Innovations, the European Federation of Pharmaceutical Industries and Association (EFPIA) is calling for the inclusion of patient experience and patient preferences in Health Technology Assessment (HTA) evaluation and pricing and reimbursement decisions. 14 November 2019
Pharmaceutical
Swiss pharma giant Novartis announced on Wednesday announced a new strategy to broaden patient reach and availability of its portfolio of medicines in sub-Saharan Africa (SSA), which is home to the largest underserved patient population in the world. 14 November 2019
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER), which has been under fire for the way it assesses the cost-effectiveness of new medicines, has finalized a set of adaptations to its value assessment framework to be applied when assessing potential cures and other treatments that qualify as high-impact “single or short-term therapies,” or SSTs. 13 November 2019
Pharmaceutical
British drugmaker GW Pharmaceuticals has won a positive UK reimbursement decision for two of its medicines, Epidyolex (cannabidiol) and Sativex (nabiximols). 11 November 2019
Pharmaceutical
In 2016 the UK’s Cancer Drugs Fund (CDF) was set up by the NHS England to give patients fast-access to cancer drugs not routinely available on the National Health Service (NHS). 8 November 2019
Generics
Indian pharma company Lupin is in advanced talks to sell its Japanese generics subsidiary, Kyowa Pharmaceutical, to a local player. 7 November 2019
Pharmaceutical
Sales of drugs in Russian pharmacies during the period of January-September 2019 fell by 1.5% in volume terms to 3.8 billion packages, marking the first sales’ decline in the Russian pharmaceutical retail since 2015, according to recent statistics, published by the Russian Ministry of Health and various local analyst agencies, reports The Pharma Letter’s local correspondent. 5 November 2019
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) on Friday released an Evidence Report assessing the comparative clinical effectiveness and value of Danish diabetes care giant Novo Nordisk’s (NOV: N) newly-approved oral semaglutide, now trade-named Rybelsus, a GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus. 4 November 2019
Pharmaceutical
The latest tuberculosis (TB) drug to be the subject of a Médecins Sans Frontières/Doctors Without Borders (MSF) campaign is pretomanid, following the Global Drug Facility announcing its price. 29 October 2019
Biotechnology
US biotech Amgen has said that, from December 31, 2019, its PCSK9 inhibitor Repatha (evolocumab) will be available exclusively at its lower list price in the USA. 24 October 2019
Pharmaceutical
A hard-fought deal between the UK’s reimbursement agencies and cystic fibrosis (CF) drug developer Vertex Pharmaceuticals will see patients in England finally gain access to modern CF treatments. 24 October 2019
Pharmaceutical
In New York, shares in American drugmaker Eli Lilly fell almost 4% by mid-morning on Wednesday, after a third quarter results statement revealed the firm had missed sales expectations amid steep discounts for diabetes drug Trulicity (dulaglutide). 23 October 2019
Pharmaceutical
Amid the forthcoming introduction of new rules for re-registration of prices for vital drugs in Russia and associated with this the increase of costs, global drugmakers operating in Russia are looking for ways to optimize their Russian business, reports The Pharma Letter’s local correspondent. 22 October 2019
Pharmaceutical
The Italian Antitrust Authority has opened an investigation against Essetifin SpA, Leadiant Biosciences SpA, Leadiant Biosciences Ltd, Leadiant GmbH and Sigma-Tau Arzneimittel GmbH, belonging to the Leadiant group, to verify the allegation that the latter abused its dominant position in the Italian market for the production and sale of chenodeoxycholic acid (CDCA)-based medicines for the treatment of the rare disease, cerebrotendinous xanthomatosis. 19 October 2019
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) yesterday released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and long-term value for money of Janssen Pharmaceuticals’ Xarelto (rivaroxaban) and Vascepa (icosapent ethyl) from Amarin Pharma =as additive treatments for cardiovascular disease (CVD). 18 October 2019
Biotechnology
The USA’s Biotechnology Innovation Organization’s (BIO), after the Congressional Budget Office (CBO) released an analysis confirming that Bill HR 3 will lead to fewer new medicines for patients, issued its own warning. 18 October 2019
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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