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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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Belgian biotech Galapagos has announced that the UK's National Institute of Health and Clinical Excellence (NICE) has recommended the use of Jyseleca (filgotinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) when other treatments have not been successful. 1 June 2022
Biosimilars
With media and politicians calling attention to the problem of rising drug prices, it’s important to remember one fact: Generic and biosimilars represent the only segment of health care in the USA that consistently reduces costs, noted the USA’s Association for Accessible Medicines (AAM). 1 June 2022
Pharmaceutical
In a letter to shareholders, Takeda Pharmaceutical chief executive Christophe Weber has explained that drug manufacturers may be forced to cut prices in the near term. 1 June 2022
Biosimilars
Novartis’ generics and biosimilar unit Sandoz has announced the launch of a new global initiative. 31 May 2022
Pharmaceutical
Pherecydes Pharma has been granted AAC Early Access Program approval by France’s Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) for its anti-Staphylococcus aureus (S. aureus) phages. 31 May 2022
Generics
As Januvia/Janumet (sitagliptin), a Merck & Co drug, nears patent expiry, India's drug price regulator National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of fixed-dose combinations of several anti-diabetic drugs with a 50% reduction on the patented component in a move set to increase the price war in India's $2.3 billion anti-diabetic drugs market. Howls of protest have followed the move, reports The Pharma Letter’s India correspondent. 30 May 2022
Pharmaceutical
ViiV Healthcare has today announced that it is committing to license its patents relating to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) and is entering into negotiation on voluntary licensing terms with the UN-backed Medicines Patent Pool (MPP). 27 May 2022
Biotechnology
The race to meet sudden, stratospheric demand for new anti-obesity meds is hotting up, but Novo Nordisk CEO Lars Fruergaard Jørgensen takes a collegiate approach. 26 May 2022
Pharmaceutical
US pharma giant Pfizer has launched an initiative that it calls ‘An Accord for a Healthier World’. 25 May 2022
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Determination recommending Libtayo (cemiplimab). 25 May 2022
Pharmaceutical
A new coalition in oncology will forge an innovative model of collaboration with the goal of boosting access to cancer medicines. 20 May 2022
Pharmaceutical
The leading Australian trade body for the pharmaceutical industry, Medicines Australia, said it has alerted “hundreds of key stakeholders to get ready to engage” in the next government review of the country’s health technology assessment (HTA) system. 20 May 2022
Pharmaceutical
The local subsidiary of Danish diabetes care giant Novo Nordisk, the sponsor of semaglutide (Ozempic) solution for injection pre-filled pen, notified the Therapeutic Goods Administration (TGA) of a shortage of both strengths of semaglutide (Ozempic) products due to an unexpected increase in consumer demand. 19 May 2022
Generics
Along with all the other medicines supply problems that the country has recently encountered, Russia is now facing a shortage of anti-HIV drugs, despite a significant increase of their procurements by the state in recent years, reports The Pharma Letter’s local correspondent. 18 May 2022
Pharmaceutical
Around 4,500 women in England with uterine fibroids will be eligible for a new oral treatment after the National Institute of Health and Care Excellence (NICE) recommended relugolix with estradiol and norethisterone acetate, trade name Ryeqo and to be marketed by Hungarian drugmaker Gedeon Richter. 14 May 2022
Biotechnology
Anglo-Swedish pharma major AstraZeneca saw its shares rise 2.8% to 10,244 pence as markets were closing today, as it announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended Imfinzi (durvalumab) for routine use within NHS England as monotherapy for the treatment of locally advanced stage III unresectable (unable to surgically remove) non-small-cell lung cancer (NSCLC) in adults whose tumors express a protein called PD-L1 on at least 1% of tumor cells, and whose disease has not progressed following concurrent platinum-based chemoradiation therapy (cCRT). 13 May 2022
Pharmaceutical
The USA’s medicine cost watchdog the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of the following outpatient treatments for COVID-19: 10 May 2022
Biotechnology
Takeda Pharmaceutical has provided an update on an initiative for improving early access to treatments for rare diseases in India. 9 May 2022
Biotechnology
The year 2021 was important for the development of new gene-, cell- and tissue-based therapies, and the Alliance for Regenerative Medicines (ARM) says this year will be another year of growth and progress for these advanced therapies, according to its 2021 annual report. 9 May 2022
Pharmaceutical
Central nervous system (CNS) specialist Axsome Therapeutics expects to receive a complete response letter (CRL) from the FDA due to the recently revealed chemistry, manufacturing, and control (CMS) issues identified during the FDA’s review of its new drug application for AXS-07 (rizatriptan and meloxicam), for the acute treatment of migraines. 29 April 2022
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