Pricing, reimbursement and access
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Pharmaceutical
The heads of 36 European pharma trade groups have met in Vienna to discuss key issues affecting the pharmaceutical and biotech industries in the EU today. 29 October 2018
Pharmaceutical
Featured regulatory news last week included US Food and Drug Administration approval for Sanofi and Regeneron’s Dupixent in the all important asthma indication. Among new clinical trial data, there was disappointment for Merrimack Pharma’s MM-121 in a lung cancer study, and Eisai and Biogen presented new data on their Alzheimer’s candidate BAN2401, but failed to win over doubters. On the deal-making front, AstraZeneca’s decision to expand its collaboration with France’s Innate Pharma in immuno-oncology with candidate monalizumab suggests a turnaround in the latter’s fortunes. Finally, Amgen announced a massive 60% cut in the list price of its cholesterol drug Repatha. 28 October 2018
Pharmaceutical
There was disappointing news today for US biopharma company AbbVie), when the UK cost-effectiveness body said it does not recommend its leukemia drug for National Health Service use, and sending its share price down 1.96% to $80.13 by late morning. 26 October 2018
Pharmaceutical
Roche was one of the worst hit by pledges made by US President Donald Trump on Medicare drug prices on Thursday. 26 October 2018
Biotechnology
Amgen said yesterday that it is making its PCSK-9 inhibitor Repatha (evolocumab), an innovative biologic medicine for people with high cholesterol who are at risk for heart attacks and strokes, available at a reduced list price. 25 October 2018
Biotechnology
The UK Secretary of State for Health and Social Care has announced that the PCSK9 inhibitor class has been selected as a treatment that needs to see a rapid increase in uptake to ensure that patients, and the National Health Service (NHS), get the benefits of this class of medicines. 24 October 2018
Biotechnology
Campaign group Médecins Sans Frontières (MSF) has called on Johnson & Johnson to slash the price of its tuberculosis (TB) drug Sirturo (bedaquiline) by 50%. 24 October 2018
Pharmaceutical
Following more than two years of groundwork, the Hungarian government’s health department has decided about the inclusion of 29 new, innovative medicines and their indications into subsidy, affecting several therapeutic fields, providing the most effective treatment for the illnesses concerned, according to the latest issue of the Hungarian Official Journal. 19 October 2018
Pharmaceutical
A new study has found significant variations between European countries in the time it takes for reimbursement decisions to be made on new cancer drugs, with some taking twice as long as others. 19 October 2018
Pharmaceutical
A new report from industry analyst the IQVIA Institute finds that, with a record-breaking number of new approvals, orphan drugs accounted for 9.6% of total sales in the USA last year. 18 October 2018
Biotechnology
There was good news for two US majors with novel CGRP inhibitor migraine prevention drugs, but disappointment for another firm, when US pharmacy benefits manager (PBM) Express Scripts yesterday announced its new SafeGuardRx Migraine Care Value program, which will begin April 1, 2019. 18 October 2018
Pharmaceutical
The White House has signalled its intention to press ahead with proposals to force drugmakers to include drug pricing information in direct-to-consumer advertising, despite the apparent inability of Congress to sign up to the idea. 16 October 2018
Pharmaceutical
The trade group representing pharma in Hungary has sounded an optimistic note on the prospect of innovative new drugs being made available for free to patients in the central European country. 15 October 2018
Pharmaceutical
Chinese biotech firm Ascletis Pharma announced today Ganovo (danoprevir) is the only direct-acting anti-viral agent (DAA) eligible for Shaoxing government funding subsidy, according to Shaoxing's Action Plan to Accelerate Prevention and Treatment of Hepatitis C issued recently. 15 October 2018
Biotechnology
US cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of therapies for long-term prophylaxis against hereditary angioedema (HAE) attacks. 12 October 2018
Pharmaceutical
For a very long time executives visiting or living in Japan agonized over what they perceived as resistance to change and a drawn out, time consuming decision-making process, writes long-time Japan pharma watcher and president of International Alliances Limited P Reed Maurer in his exclusive column for The Pharma Letter. 11 October 2018
Pharmaceutical
US President Donald Trump has signed legislation preventing so-called ‘gag clauses,’ used for years by pharmacy benefit managers to restrict access to cheaper off-plan options. 11 October 2018
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Crysvita (burosumab) within its marketing authorization, for treating X-linked hypophosphatemia (XLH) in children and young people with growing bones in England and Wales. 10 October 2018
Pharmaceutical
During the third quarter, pharmaceutical pricing dynamics remained under scrutiny. Specifically, regulators have highlighted the elimination of rebates as a way to protect consumers since patients' out-of-pocket expenses are influenced by the list, rather than net, price of each therapy. 9 October 2018
Pharmaceutical
A final report from the Institute for Clinical and Economic Review (ICER) finds that the pricing of new therapies for the treatment of hereditary transthyretin amyloidosis (hATTR) “far exceeds commonly cited thresholds for cost effectiveness.” 8 October 2018
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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