Pricing, reimbursement and access
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Generics
The UK’s Competition and Markets Authority (CMA) has imposed over £100 million ($139 million) in fines after Advanz inflated the price of thyroid tablets, causing the National Health Service (NHS) and patients to lose out. 30 July 2021
Generics
The US Association for Accessible Medicines (AAM) last week released a white paper, “New Generics Are Less Available in Medicare Than Commercial Plans.” 26 July 2021
Biotechnology
The international medical humanitarian organization Médecins Sans Frontières (MSF) says that trial results in HIV-related cryptococcal meningitis with a Gilead Sciences drug further compel the company to improve access. 21 July 2021
Pharmaceutical
National Health Service (NHS) patients in England are set to benefit from early access to potentially life-saving new medicines, including cutting-edge gene therapies, thanks to a new Innovative Medicines Fund and £680 million ($925 million) of ringfenced funding, the NHS chief executive has announced today. 21 July 2021
Pharmaceutical
Drug prices are steadily rising in Russia due to the weak rouble and the ever-growing prices for raw materials, most of which are traditionally imported to Russia from abroad, reports The Pharma Letter’s local correspondent. 20 July 2021
Pharmaceutical
The Institute of Cancer Research (ICR) has hit out at a decision by the National Institute for Health and Care Excellence (NICE) not to recommend Zytiga (abiraterone) as a first-line National Health Service (NHS) treatment for newly-diagnosed, advanced prostate cancer. 15 July 2021
Pharmaceutical
Israel’s RedHill Biopharma on Tuesday announced that one of America’s largest payors, serving many Blue Cross and Blue Shield Plans and more than 30 million members, has added Movantik (naloxegol), a peripherally acting mu-opioid receptor antagonist (PAMORA) for opioid-induced constipation (OIC), as a preferred brand with no restrictions to a National Formulary and as a preferred brand on its other commercial formularies starting July 1, 2021. 14 July 2021
Pharmaceutical
Shionogi has teamed up with the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI) to accelerate access, including in low- and middle-income countries, to the antibiotic cefiderocol for bacterial infections in patients with limited treatment options. 13 July 2021
Pharmaceutical
On Friday, US President Joe Biden issued a wide ranging Executive Order seeking to address overconcentration, monopolization, and unfair competition in the US economy. 13 July 2021
Pharmaceutical
The production of drugs in Russia for the first five months of the current year fell by almost 10% on year-on-year basis to 1.7 billion units in volume terms, but grew by 25.9% up to 239.1 billion roubles ($3.2 billion) in terms of value, according to a study conducted by the Russian analytics company RNC Pharma. 13 July 2021
Biotechnology
England’s health technology assessor, the National Institute for Health and Care Excellence (NICE), has dealt a blow to Orchard Therapeutics’ reimbursement goals for atidarsagene autotemcel. 12 July 2021
Biotechnology
The USA's Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of a host of therapies for atopic dermatitis (AD). 9 July 2021
Biotechnology
The UK’s reimbursement agency has recommended the use of Novartis’ Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy (SMA) in babies. 8 July 2021
Biosimilars
The International Generic and Biosimilar Medicines Association (IGBA) has launched a whitepaper: A Vision for the Global Generic and Biosimilar Medicines Industry, which covers the strong contribution of this pharmaceutical sector to global health outcomes and economies, the opportunities, challenges and disruptions for the industry, its 2030 vision as well as actions needed to achieve this vision. 8 July 2021
Biosimilars
Biosimilar competition has the potential to provide greater access to important treatments for America’s patients and cost savings for the nation’s health care system of as much as $130 billion by 2025, notes the Biosimilars Council, a division of the USA’s Association for Accessible Medicines (AAM). 7 July 2021
Generics
In an exceptional measure, India’s pricing regulator the National Pharmaceutical Pricing Authority (NPPA) has allowed a one-time price hike of 50% for three key drugs - ranitidine (antacid), ibuprofen (analgesic), and carbamazepine (epilepsy). 7 July 2021
Pharmaceutical
The Russian Ministry of Health wants to sign long-term contracts with global drugmakers on supplies of their drugs against HIV, hepatitis and rare diseases for state needs. As part of state plans, that will allow the achievement of significant savings during public procurements of these drugs, reports The Pharma Letter’s local correspondent. 6 July 2021
Pharmaceutical
Russian Prime Minister Mikhail Mishustin has signed a decree to allocate 17.9 billion roubles ($244 million) for the needs of the Circle of Kindness Foundation, a Russian public fund specializing on the procurement of high-priced drugs for children with severe and rare diseases. 5 July 2021
Pharmaceutical
Since July 2020, remdesivir has been conditionally approved in Europe for the treatment of coronavirus disease (COVID-19) in adults and adolescents aged 12 years and older with pneumonia who require supplemental oxygen but no invasive ventilation. 5 July 2021
Biotechnology
The Indian subsidiary of Anglo-Swedish pharma major AstraZeneca has filed a writ petition before the Delhi High Court challenging a demand notice from India's National Pharmaceutical Pricing Authority (NPPA) alleging overcharging of Tagrisso (osimertinib) tablets by the company. 1 July 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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