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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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Biotechnology
Today Germany’s Merck KGaA and US pharm giant Pfizer announced that, following a successful appeal of the prior negative Final Appraisal Document (FAD), the UK’s National Institute for Health and Care Excellence (NICE) has overturned its decision and now recommends the immunotherapy Bavencio (avelumab) as a maintenance treatment option in eligible adult patients with locally advanced or metastatic urothelial carcinoma (UC), also known as bladder cancer. 7 April 2022
Pharmaceutical
The Russian Ministry of Health has prepared a list of 39 anticancer drugs that are likely to be in short supply in the country due to ongoing military conflict between Ukraine and Russia and Western sanctions imposed on Russia, reports The Pharma Letter’s local correspondent. 7 April 2022
Generics
Widely researched and resourced during the early stages of the COVID-19 pandemic, repurposing has shown its worth in an emergency. Facilitating repurposing beyond the pandemic promises sustainable developments and patient centric health outcomes in a range of therapy areas, comments Medicines for Europe, the trade group that represents generic and biosimilars drugmakers in the region. 7 April 2022
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca and Merck & Co’s Koselugo (selumetinib) for use by the National Health Service (NHS) in England. 6 April 2022
Biosimilars
According to a report from the US Department of Health and Human Service (HHS) Office of Inspector General (OIG), Biologics - usually large, complex molecules produced in a living system - are some of the most expensive drugs available, and spending for biologics is growing in Medicare Part D because they treat diseases common among Medicare beneficiaries. 4 April 2022
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended Evenity (romosozumab) for use by the National Health Service (NHS) in England and Wales for severe osteoporosis in people after menopause at high risk of fracture. 1 April 2022
Biotechnology
The UK health technology assessor the National Institute for Health and Care Excellence on Thursday advised the National Health Service in England to not provide Novartis' Piqray (alpelisib) with fulvestrant to post-menopausal women and men with a certain type of advanced breast cancer. 1 April 2022
Pharmaceutical
The USA-based Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of the following treatments for COVID-19: 28 March 2022
Pharmaceutical
The pharmaceutical industry is faced by a multi-dimensional challenge of revenues under pressure, increasing regulatory requirements which differ across localities, dispersed data sources, innovation in technology and staffing pressures. 23 March 2022
Pharmaceutical
The UK’s medicine costs watchdog the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending US biotech company BioMarin Pharmaceutical Vimizim (elosulfase alfa) for routine use in the National Health Service (NHS) for the treatment of mucopolysaccharidosis type 4A (also known as MPS 4A and Morquio A syndrome). 22 March 2022
Pharmaceutical
An Expert View from Jennifer Romanski, a principal of Porzio, Bromberg & Newman and a co-chair of its Life Sciences Compliance and Regulatory Counseling Department. She is also a senior vice president at Porzio Life Sciences, a wholly-owned subsidiary of the law firm. 18 March 2022
Generics
The Medicines Patent Pool (MPP) has signed agreements with 35 companies to manufacture the generic version of Pfizer’s oral COVID-19 treatment Paxlovid (nirmatrelvir/ritonavir) to be supplied in 95 low- and middle-income countries. 17 March 2022
Pharmaceutical
Boston, USA-based pricing watchdog The Institute for Clinical and Economic Review (ICER) has published a revised assessment of the relative merits of two possible competitors in hematology. 17 March 2022
Generics
To help combat the nationwide insulin affordability crisis, Civica Rx, a non-profit generic pharmaceutical company, has launched its Insulin Initiative with the JDRF. The initiative aims to drive affordability and accessibility for all Americans, regardless of insurance status. 17 March 2022
Biotechnology
Swedish enzyme specialist Hansa Biopharma has secured reimbursement for Idefirix (imlifidase) in Germany. 15 March 2022
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended the use of Darzalex (daratumumab) monotherapy for adult patients with relapsed and refractory multiple myeloma that has previously been treated with three therapies, including a proteasome inhibitor and an immunomodulator, and who have demonstrated disease progression on the last therapy. 15 March 2022
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency (Pharmac) has just released its Options for Investment (OFI) list, which includes 36 new medicines since it was updated in July 2021. The OFI includes all medicines that Pharmac would fund if its budget allowed. 10 March 2022
Biotechnology
At the national level, drug pricing continues to be a hot button issue for lawmakers, drugmakers and patients in the USA. At the state level, could Prescription Drug Affordability Boards (PDAB) be the answer? 4 March 2022
Generics
USA-based Civica Rx, the non-profit generic drugmaker set up by hospital systems in 2018 to help counter rising prices and supply shortages, has announced plans to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. 4 March 2022
Biotechnology
Today, US biotech giant Amgen’s first-in-class medicine, Lumykras (sotorasib), has been recommended by the UK’s National Institute for Health and Care Excellence (NICE), following an accelerated marketing authorization through Project Orbis last year. 3 March 2022
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