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Pharmaceutical
ViiV Healthcare, which is majority owned by GlaxoSmithKline, today announce that eligible people living with Human Immunodeficiency Virus (HIV) in England and Wales will soon have routine access to Vocabria (cabotegravir long-acting injection), developed by ViiV Healthcare, in combination with Rekambys (rilpivirine long-acting injection), developed by Janssen, a Johnson & Johnson subsidiary. 18 November 2021
Biosimilars
Biologic medicines are among the most innovative drugs to treat many life-threatening conditions, including cancer and autoimmune diseases. 17 November 2021
Biotechnology
Bristol Myers Squibb has welcomed the positive recommendations of the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, relating to two of its cancer drugs. 17 November 2021
Biotechnology
The Institute for Clinical and Economic Review (ICER) has published a Final Evidence Report assessing the comparative clinical effectiveness and value of mavacamten, a drug being developed for hypertrophic cardiomyopathy (HCM). 17 November 2021
Biotechnology
China’s biotech industry enjoyed significant growth in the past several years, but major bottlenecks are looming as Chinese biotechs aims for a global expansion, said speakers at the two-day event Chinatrials on November 11 in Shanghai. 17 November 2021
Pharmaceutical
More than 20,000 strokes and 5,000 deaths could be averted after NHS England struck new agreements to expand life-saving blood thinning drugs, chief executive Amanda Pritchard announced yesterday. 17 November 2021
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) regularly calls out drugmakers in certain therapy areas for introducing drugs to the market at prices that exceed its estimates of what they are worth. 16 November 2021
Pharmaceutical
Switzerland-based Arvelle Therapeutics, which was acquired by Italy’s Angelini earlier this year, today announced that it has received a positive Final Appraisal Determination (FAD) from the National Institute for Health and Clinical Excellence (NICE) for Ontozry (cenobamate). 15 November 2021
Biotechnology
The UK’s health technology assessor the National Institute for Health and Care Excellence (NICE) has published positive guidance, in the form of a Final Appraisal Determination (FAD), confirming that Poteligeo (mogamulizumab) is recommended as a treatment option for adults in England and Wales with the ultra-rare blood cancers mycosis fungoides (MF) and Sézary syndrome (SS), two forms of cutaneous T-cell lymphoma (CTCL). 12 November 2021
Pharmaceutical
As the initial waves of the coronavirus pandemic hit in early 2020, pharma and biotech stocks saw major declines as investors digested the likely impact. 11 November 2021
Pharmaceutical
More than 90% of the approved identified rare diseases lack an approved treatment option. 10 November 2021
Pharmaceutical
The National Institute for Health and Care Excellence's (NICE) consultation on the proposed changes to its methods and processes of health technology assessment closed on October 13. Here Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, provides an Expert View on the proposed fresh approach to health technology assessment and how this will allow continued fair and fast access to medicines in the National Health Service (NHS). 5 November 2021
article
Anglo-Swedish pharma major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) has issued an Appraisal Consultation Document (ACD) for Forxiga (dapagliflozin) within its marketing authorization for the treatment of adults with chronic kidney disease (CKD). 5 November 2021
Pharmaceutical
Campaigners were furious last week at the news that US President Joe Biden’s Build Back Better framework would exclude a plan permitting Medicare to use its bargaining power to lower the price of prescription drugs for Americans. 4 November 2021
Biotechnology
US health technology assessor the Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of tezepelumab. 4 November 2021
Biosimilars
Copycat biologics are helping to expand access to care for cancer patients, according to a report from the Association for Accessible Medicines (AAM), which represents the USA’s generics and biosimilars companies. 3 November 2021
Pharmaceutical
Groups campaigning for lower US drug prices reacted with exasperation last week when President Joe Biden announced the framework for his Build Back Better Agenda and Bipartisan Infrastructure Bill. 1 November 2021
Pharmaceutical
pharma.be, the umbrella organization of 125 innovative pharmaceutical companies active in Belgium, regrets that the Constitutional Court has not taken an explicit decision to annul the discriminatory “clawback” measure in the pharmaceutical budget. 1 November 2021
Pharmaceutical
US President Joe Biden was never going to please everyone in announcing the framework for his Build Back Better Agenda and Bipartisan Infrastructure Bill, but the absence of provisions to lower drug prices is an issue that has caused particular anger among some Americans. 29 October 2021
Pharmaceutical
Non-profit organization the Medicines Patent Pool (MPP) and MSD, the ex-North America name of Merck & Co, have signed a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral medicine developed by the US pharma giant. 27 October 2021
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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