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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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Pharmaceutical
Speaking at his party’s annual conference in Brighton, UK, Labour leader Jeremy Corbyn said he would legislate to create a state-run generic drugs firm, if elected. 25 September 2019
Generics
China is changing the way it buys generic products, seeking to pressure drumakers and drive down prices. 25 September 2019
Pharmaceutical
Global pharmaceutical companies hope to increase their share of public procurements in Russia as soon as this year, thanks to the new methodology on the formation of the initial maximum price for state contracts, which has been recently introduced by the Russian Ministry of Health, reports The Pharma Letter’s local correspondent. 23 September 2019
Pharmaceutical
Heavy rains across several parts of India have provided a shot in the arm for anti-infective drugs that have been on the decline for the past several months. The category of anti-infective drugs grew at 15.3% year-on-year in August, compared to the Indian pharmaceutical market growth of 9.4%, reports The Pharma Letter’s India correspondent. 23 September 2019
Pharmaceutical
The news last week that Denmark’s Lundbeck is to acquire Alder Biopharmaceuticals and its migraine prevention drug eptinezumab for as much as $1.95 billion has raised some questions. Regulatory news featured Aimmune gaining US Food and Drug Administration advisory panel support for its peanut allergy treatment Palforzia, and Janssen/Johnson & Johnson’s prostate cancer drug Erleada getting FDA approval. On the pricing front there was a new proposal from the US Democrats proposing negotiating Medicare prices for drugs that have no direct competition. 22 September 2019
Biotechnology
On Thursday, US House of Representatives Speaker Nancy Pelosi unveiled drastic proposals that would allow Medicare to negotiate lower prices on as many as 250 drugs and apply those discounts to private health plans. 19 September 2019
Pharmaceutical
The National Institute for Health and Clinical Excellence (NICE), the health technology appraisal body in England and Wales, has issued its Final Appraisal Determination (FAD) recommending Takhzyro (lanadelumab) subcutaneous injection as an option for preventing recurrent attacks of hereditary angioedema (HAE). 18 September 2019
Pharmaceutical
Last month the independent Scottish Medicines Consortium assessed that Vertex Pharmaceuticals’ (Nasdaq: VRTX) ‘justification of the treatment’s [Orkambi (lumacaftor/ivacaftor) and Symkevi (tezacaftor/ivacaftor)] costs in relation to its health benefits was not sufficient’ - meaning the company was charging an unreasonably high price for its product. 16 September 2019
Pharmaceutical
Denmark’s Novo Nordisk was in the news last week, first with the launch of its own generic NovoLog, aiming to help provide cheaper insulin in the USA, and second with a mixed report from US cost-effectiveness watchdog the ICER evaluating the diabetes care giant’s oral semaglutide. On the research front, adding to the litany of Alzheimer disease failures, were disappointing Phase III results for Neurotrope’s bryostatin-1, but Acadia Pharmaceuticals pleased investors with positive trial readings for its dementia drug Nuplazid. Also attracting attention was Sanofi’s decision to terminate its four-year collaboration with Lexicon Pharma on the diabetes drug Zynquista. 15 September 2019
Pharmaceutical
An evidence report from The Institute for Clinical and Economic Review (ICER) finds in favor of the cost-effectiveness of both Xarelto (rivaroxaban) and Vascepa (icosapent ethyl), as additive cardiovascular disease (CVD) therapies. 13 September 2019
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) on Wednesday released a Draft Evidence Report assessing the comparative clinical effectiveness and value of Danish diabetes care giant Novo Nordisk’s oral semaglutide and other treatments for type 2 diabetes mellitus. 12 September 2019
Biotechnology
A survey from industry analyst Spherix Global Insights suggests that more people may be using anti-calcitonin gene-related peptide (CGRP) therapies for episodic migraines than had been reported. 11 September 2019
Biosimilars
Industry group the Alliance for Safe Biologic Medicines (ASBM) has voiced objections to a Canadian Province using biosimilar medicines to treat inflammatory bowel disease (IBD). 11 September 2019
Generics
Though India's Department of Pharmaceuticals (DoP) rejected Cipla’s review application against the price fixed for its budesonide inhalation formulation, it has directed the National Pharmaceutical Pricing Authority (NPPA) to extend the price increase on tenofovir, indicated for the treatment of chronic hepatitis B. 10 September 2019
Biotechnology
Lower insulin prices from Danish diabetes giant Novo Nordisk (NOV: N) will be welcomed by millions of Americans with diabetes who struggle to afford their medicine. 9 September 2019
Pharmaceutical
Recovery from the post August lull and US Labor Day holidays kicked off last Tuesday with a not mega M&A deal – Vertex Pharma’s $950 million agreed bid for pre-clinical biotech firm Semma Therapeutics and its diabetes candidate – but nonetheless one that attracted attention. Also of note was Japanese drugmaker Sumitomo Dainippon’s offer on Friday to pay $3 billion to acquire a number of “vant” companies from Roivant Sciences. Among research news, Ardelyx thrilled investors with its Phase III results for tenapanor for people with chronic kidney disease on dialysis, and, on the pricing front, the UK’s cost-effectiveness watchdog, the NICE, on Thursday agreed to recommend Novartis’ eye disease gene therapy Luxturna. 8 September 2019
Biotechnology
A novel gene therapy treatment for a rare inherited eye disorder has been recommended by the UK’s National Institute for Health and Care Excellence (NICE) for use on the National Health Service (NHS). 5 September 2019
Biotechnology
A new study shows that the hemophilia A and B market is expected to grow from $7.0 billion in 2018 to $9.3 billion by 2028 across the eight major markets (8MM: USA, France, Germany, Italy, Spain, UK, Japan and China), expanding at a compound annual growth rate (CAGR) of 2.9%. 5 September 2019
Biosimilars
Britain’s National Health Service (NHS) says that, as a result of its Long Term Plan, annual savings of more than £700 million ($853 million) have been achieved through the use of biosimilars and generics. 2 September 2019
Pharmaceutical
Australian Federal Health Minister Greg Hunt announced on Sunday that Swedish drugmaker Camurus’ long-acting medication Buvidal (buprenorphine) Weekly and Monthly solutions for injection will be listed on the country’s Pharmaceutical Benefit Scheme (PBS). 26 August 2019
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