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Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending German family-owned pharma major Boehringer Ingelheim’s Vargatef (nintedanib). 2 June 2015
Pharmaceutical
Drugmakers have been challenged on the cost of new cancer therapies by the chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center at ASCO. 2 June 2015
Pharmaceutical
The National Institute for Health and care Excellence (NICE) has today (June 1) opened a consultation preliminary draft guidance on the drug Anglo-Swedish pharma major AstraZeneca’s olaparib. 1 June 2015
Pharmaceutical
The Ukrainian pharmaceutical trade body the APRaD has issued a notice of its position on the Resolution of the Cabinet of Ministers of Ukraine (CMU) on some issues of state regulation of prices for medicines (the National List of Essential Medicines) in the context of improving patients' access to innovative medicines and necessary therapies. 1 June 2015
Pharmaceutical
The representative body for the Australian pharma industry, Medicines Australia, has agreed to sign a ‘letter of intent’ with the Australian government for a five-year strategic agreement. 27 May 2015
Pharmaceutical
Delegates at the World Health Assembly have endorsed a global action plan to tackle antimicrobial resistance, including access to affordable vaccines. 26 May 2015
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed documents subsequently submitted by US biotech giant Gilead Sciences in the commenting procedure on the dossier assessment of the firm’s new blockbuster hepatitis C drug Harvoni (ledipasvir and sofosbuvir). 22 May 2015
Biotechnology
The benefit assessment by Germany's Federal Joint Committee (G-BA) indicated that US biotech firm PTC Therapeutics’ Translarna (ataluren) provided a benefit for ambulatory patients aged five years and older with nonsense mutation Duchenne muscular dystrophy (nmDMD). 22 May 2015
Pharmaceutical
Despite the optimism surrounding two first-in-class products, vaccination alone is not a viable long-term solution for combatting these infectious diseases, says an analyst. 21 May 2015
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined two dossier relating to US biotech firm Celgene’s Otezla (apremilast) as to whether this drug offers an added benefit over the respective appropriate comparator therapy. 19 May 2015
Pharmaceutical
Australia’s medicine industry has called on the Abbott Government to negotiate a five-year strategic agreement after reaching an in-principle deal with the Pharmacy Guild of Australia to ensure access to the best Pharmaceutical Benefits Scheme. 18 May 2015
Pharmaceutical
Spanish trade group Farmaindustria’s General Assembly gathered last week in an extraordinary meeting and authorized the signing of a Collaboration Protocol with the Ministries of Finance & Public Administrations, and Health, Social Services and Equality. 3 May 2015
Pharmaceutical
The value of the Russian pharmaceutical market amounted to 156.1 billion roubles (around $3 billion) in wholesale prices in the first quarter of 2015, which is 25% more than during the same period of 2014. 29 April 2015
Pharmaceutical
Kim Ok-Yeon, chairperson of the KRPIA, South Korea’s research-based pharmaceutical industry association, pointed out, regarding to the Pharma 2020 Vision announced by the government in 2012, that local pharmaceutical companies face significant difficulties in procuring competitiveness in overseas markets. 27 April 2015
Pharmaceutical
The US Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a Federal Register Notice soliciting comments on its proposal to collect pricing data from drug manufacturers under the 340B drug discount program. 23 April 2015
Generics
At the urging of US Senator Bernie Sanders and Representative Elijah Cummings, the Department of Health and Human Services’ Inspector General has agreed to investigate how sudden price hikes by generic drug makers are driving up the cost of taxpayer-supported health care. 16 April 2015
Pharmaceutical
French drug major Sanofi is to initially target newly-diagnosed patients with its recently-approved once-daily, long-acting basal insulin Toujeo (insulin glargine), but will not offer a discount against Lantus (insulin glargine), according to reports by Bloomberg. 14 April 2015
Pharmaceutical
The Scottish Medicines Consortium (SMC) today announced that German pharma major Bayer’s Stivarga (regorafenib) has been accepted for use within NHS Scotland. 13 April 2015
Pharmaceutical
Trade group the Irish Pharmaceutical Healthcare Association (IPHA) has said that a report published by the Health Services Executive (HSE) this week shows that the average price of a pack of medicine provided to patients through the community drugs schemes decreased to its lowest level in a decade. 13 April 2015
Pharmaceutical
Canada’s Research-Based Pharmaceutical Companies (Rx&D) trade group has expressed concerns about the Patented Medicines Prices Review Board’s (PMPRB) newly-released report on Cost Drivers of Public Drug Plans in Canada. 2 April 2015
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