Pricing, reimbursement and access
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Pharmaceutical
The publication of a second draft recommendation not recommending use of Takeda’s Adcetris (brentuximab vedotin) in relapsed or refractory Hodgkin lymphoma (R/R HL) on the National Health Service (NHS), has prompted fresh criticism from the Japanese drugmaker. 16 December 2016
Generics
Mylan on Friday announced the US launch of the authorized generic for EpiPen (epinephrine injection, USP) Auto-Injector at a wholesale acquisition cost (WAC) of $300 per epinephrine injection, USP two-pack. 16 December 2016
Generics
The UK’s Competition and Markets Authority (CMA) has accused generic drugmaker Actavis UK of breaking competition law by raising the price for hydrocortisone tablets paid by the National Health Service. 16 December 2016
Pharmaceutical
The prices of prescription branded drugs widely used by older Americans rose by an average of 15.5% in 2015, some 130 times above inflation, according to a new report. 15 December 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Japanese drugmaker Takeda’s Adcetris (brentuximab vedotin) to treat some patients with Hodgkin’s lymphoma on the National Health Service (NHS). 15 December 2016
Generics
The US Department of Justice (DoJ) has announced two former senior generic pharmaceutical executives have been charged over price-fixing of generic medicines. 15 December 2016
Pharmaceutical
US pharma major Eli Lilly has moved to provide up to 40% discounts for US users of its insulin products from the start of 2017, as prices rise on the back of soaring insurance rates. 13 December 2016
Pharmaceutical
Despite the uncertainty that loomed over the pharma and biotech sectors with unexpected outcomes from both the US presidential election and UK’s vote to leave the EU, 2017 may bring renewed energy to the industry with potential for more corporate activity and cash flow. 9 December 2016
Generics
The UK’s Competition and Markets Authority (CMA) today announced that it has fined two compoanies nearly £90 million ($114.4 million) for charging excessive prices to the National Health Service (NHS) for an anti-epilepsy drug. 7 December 2016
Pharmaceutical
Danish diabetes giant Novo Nordisk has pledged to limit its price increases for US patients. 7 December 2016
Pharmaceutical
Over the past half-century, the prescription medication industry has witnessed phenomenal growth. To combat sharp increments in drug costs during the 1970s, states deployed laws and developed guidance material with the help of the Food and Drug Administration, writes Dr Nicola Davies in her monthly exclusive FDA Blog for The Pharma Letter. 7 December 2016
Pharmaceutical
Total spending on medicines is forecast to reach $1.5 trillion by 2021, up 33% from 2016 levels, even as annual growth moderates from the record pace set in 2014 and 2015. 6 December 2016
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued draft guidance that recommends new drug pembrolizumab for some people with advanced non-small-cell lung cancer. 2 December 2016
Pharmaceutical
As of today, December 1, Australians will pay no more than A$38.30 ($28.37) for a medicine to treat thyroid cancer that would cost a patient A$117,000 without subsidized access through the Pharmaceutical Benefits Scheme (PBS). 1 December 2016
Pharmaceutical
A US new national survey finds most voters blame drug companies not only for high drug prices, but also for out-of-pocket costs. 1 December 2016
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended a new treatment mepolizumab, in draft guidance for adults with severe asthma, reversing a negative earlier decision. 1 December 2016
Pharmaceutical
New guidance suggests that women in England with a family history of breast cancer should be offered anastrozole, not tamoxifen. 30 November 2016
Pharmaceutical
In an expert view piece, Ramon Mohanlal, chief medical officer at BeyondSpring, tackles the issue which threatens to undermine the entire drugmaking cycle. 29 November 2016
Biosimilars
Trade group Medicines for Europe, which represents the generics and biosimilars sector, has taken issue with the report ‘Health at a Glance 2016’ launched yesterday prepared by the Organization for Economic Co-operation and Development (OECD) for the European Commission. 28 November 2016
Pharmaceutical
The Belgian Competition Authority (BCA) has confirmed that it is inspecting several companies involved in the wholesale distribution of pharmaceutical and para-pharmaceuticals products to pharmacies. 25 November 2016
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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