Pricing, reimbursement and access
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Pharmaceutical
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) had determined that UK pharma giant GlaxoSmithKline’s Tafinlar (dabrafenib) has no added benefit in comparison with dacarbazine. 9 April 2014
Pharmaceutical
The World Health Organization (WHO) has issued its first guidance for the treatment of hepatitis C, a chronic infection that affects an estimated 130 million to 150 million people, on the eve of the 2014 International Liver Congress (ILC) in London. 9 April 2014
Pharmaceutical
Expensive treatments for broad patient populations are driving unprecedented growth in US spending on specialty drugs to treat complex conditions such as rheumatoid arthritis, multiple sclerosis and cancer, according to a new report issued today by Express Scripts. 9 April 2014
Pharmaceutical
In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products, the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether drug major Bayer’s Xofigo (radium-223 dichloride) offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee. 3 April 2014
Pharmaceutical
Viiv Healthcare, the HIV/AIDS joint venture of UK pharma giant GlaxoSmithKline, US drugmaker Pfizer and Japanese drug major Shionogi has announced new collaborations to increase access to its HIV medicine Tivicay (dolutegravir). 2 April 2014
Pharmaceutical
Prices for drugs in Ukraine are steadily increasing, amid the ongoing political and economical crisis in the country, according to local media reports. 25 March 2014
Biotechnology
Three leading US Congressmen have written to John Martin, chief executive of US biotech firm Gilead Sciences, raising questions about the pricing of the firm’s recently-approved hepatitis C treatment, Sovaldi (sofosbuvir). 24 March 2014
Pharmaceutical
The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued new draft guidance not recommending German drug major Bayer’s Xofigo (radium-223 dichloride) for treating adults with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases. 24 March 2014
Pharmaceutical
In new draft guidance published today, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended US health care giant Johnson & Johnson subsidiary Janssen’s Velcade (bortezomib) as a treatment for some patients with newly-diagnosed multiple myeloma. 21 March 2014
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has re-assessed the added benefit of ipilimumab, US pharma major Bristol-Myers Squibb’s Yervoy, this time seeing the data as uncertain. 19 March 2014
Pharmaceutical
Innovative medicines and other new therapies have extended life expectancy by some 10 years since the 1950s, and contributed significantly to the UK’s prosperity. But Licensed to Cure?, a new report published this week by the UCL School of Pharmacy, UK, warns that if bodies such as the UK’s National Institute for Health and Care Excellence (NICE) under‐estimate the value of their benefits this will undermine investment in research and treatment development. 14 March 2014
Biotechnology
The majority of Members of Parliament in the UK believe there should not be a maximum price per patient for treating people with very rare diseases, according to research commissioned by the trade body the BioIndustry Association (BIA). 11 March 2014
Pharmaceutical
From April 1, the Australian government will implement a new streamlined process to reduce the time taken to list medicines on the Pharmaceutical Benefits Scheme (PBS) and improve access to medicines. 7 March 2014
Pharmaceutical
UK drug watchdog the National Institute for Health and Care Excellence (NICE) this morning published preliminary guidance which recommends US pharma giant Pfizer’s Inlyta (axitinib) as an option for treating adults with advanced renal cell carcinoma after failure of treatment with a first-line tyrosine kinase inhibitor or a cytokine. 4 March 2014
Pharmaceutical
US pharma major Eli Lilly’s subsidiary in Brazil will invest 15 million real ($6.4 million) over the next two years to renew the packaging plant located in the great state of Sao Paulo, writes Juliane Carvalho on Brazil Pharma News. 3 March 2014
Pharmaceutical
As the 7th Rare Disease Day will be held on February 28, ALCIMED, an innovation and new business consulting firm, takes a closer look at the orphan drugs market and opens the debate on the potential perspectives. 27 February 2014
Biotechnology
US biotech firm Cell Therapeutics has received positive news from the UK’s drugs watchdog for use of its lymphoma drug Pixuvri (pixantrone) on the National Health Service. 27 February 2014
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published final guidance recommending German drug major Bayer’s Eylea (aflibercept solution for injection) as an option for treating visual impairment caused by macular edema, a condition which affects a person’s ability to see detail and color. 26 February 2014
Pharmaceutical
The German Bundestag (Parliament) is implementing a number of pharmaceutical policy changes within the scope of the 14th law amending Book V of the German Social Code. 26 February 2014
Pharmaceutical
US drug major Bristol-Myers Squibb today expressed its disappointment that the UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued draft guidance which effectively denies access to Yervoy (ipilimumab) for National Health Service patients with previously-untreated advanced (unresectable or metastatic) melanoma, not involved in clinical trials. 25 February 2014
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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