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Biotechnology
Sanofi today revealed that UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued final draft guidance (FDG) not recommending Sarclisa (isatuximab) plus pomalidomide and dexamethasone (Isa-Pd), within its marketing authorization 20 June 2024
Pharmaceutical
Johnson & Johnson says it has “grave concern” for the availability of future innovative mental health treatments in England, following a decision by National Institute for Health and Care Excellence (NICE) to not re-appraise Spravato (esketamine nasal spray) for treatment-resistant depression in England 13 June 2024
Pharmaceutical
US Senator Bernie Sanders, chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), has announced that members will vote next week on whether to subpoena Doug Langa, senior vice president, head of North America operations and president of Novo Nordisk. 12 June 2024
Pharmaceutical
Russia is sharply cutting centralized state purchases of anti-HIV drugs due to the problems with funding and the reduction of supplies to Russia by global drugmakers, reports The Pharma Letter’s local correspondent. 12 June 2024
Biosimilars
As more biologics drugs lose their patent protection, the influx of biosimilars is set to expand, offering cost-effective alternatives and significantly impacting their respective markets. 5 June 2024
Pharmaceutical
Last week, the US Court of Appeals for the District of Columbia (DC) ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program, noted Sophia Gaulkin and Alan Kirschenbaum of law firm Hyman Phelps & McNamara. 1 June 2024
Biosimilars
Chief Executive Officers of the world’s largest generic and biosimilar medicines companies recently met in Vienna, Austria, to provide strategic advice to the International Generic and Biosimilar Medicines Association (IGBA). 29 May 2024
Pharmaceutical
French pharma trade group Leem (Les Entreprises du Medicament) has published its annual survey on the taxation of the pharmaceutical industry, compared to that of other European countries. 28 May 2024
Generics
UK-based Alliance Pharma (AIM: APH) has successfully appealed against a Competition and Markets Authority (CMA) ruling that had found the company guilty of breaching competition law. 24 May 2024
Pharmaceutical
The US National Institutes of Health (NIH) has issued a first-of-its-kind draft policy proposal to promote equal access to products stemming from NIH-owned inventions. 23 May 2024
Pharmaceutical
Rhythm Pharmaceuticals, a US biopharma specializing in rare neuroendocrine diseases, has announced that its drug Imcivree (setmelanotide) is expected to be funded and available for use in England and Wales within three months through the National Health Service (NHS) in specialist centers. 22 May 2024
Pharmaceutical
A US Food and Drug Administration (FDA) panel will consider Lykos Therapeutics’ filing for midomafetamine capsules (MDMA) as a therapy-assisted treatment for post-traumatic stress disorder (PTSD) in early June. 15 May 2024
Biotechnology
Overall spending in the US market for medicines grew by 2.5% and reached $435 billion in 2023. 15 May 2024
Pharmaceutical
Four-year data from the SELECT trial will significantly bolster Novo Nordisk’s bid to become the GLP-1 company of choice for payers and prescribers. 15 May 2024
Pharmaceutical
A new study by diabetes awareness website Diabetes Strong reveals that “How to get Ozempic” is the most googled question about the medication. 14 May 2024
Biosimilars
The US unit of South Korea’s Celltrion announced that adalimumab-aaty, the company's high-concentration (100 mg/mL) and citrate-free formulation biosimilar to Humira (adalimumab), is now available at a low wholesale acquisition cost (WAC). 13 May 2024
Pharmaceutical
Half of pharma execs are bracing for significant revenue impact from Medicare price negotiations this year, compared to just 22% in 2023, according to research from revenue and compliance experts at Model N. 7 May 2024
Generics
The COVID-19 pandemic has underscored the vulnerabilities inherent in global supply chains, particularly those predicated on single-country reliance. 2 May 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm). 1 May 2024
Pharmaceutical
Trade group the Association of the British Pharmaceutical Industry (ABPI) has published an executive summary of its consultation response to the government's proposed changes to the Statutory Scheme for branded medicines. 1 May 2024
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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