Pricing, reimbursement and access
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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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
The National Institute for Health and Care Excellence (NICE) has recommended Keytruda (pembrolizumab) for inclusion in the UK’s Cancer Drugs Fund (CDF) as the first immunotherapy for a specific population of previously untreated metastatic non-small-cell lung cancer (NSCLC). 30 May 2017
Generics
Even as India’s National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of 31 more drug formulations, in yet another crackdown on prices, India's premier policy formulating agency Niti Aayog has proposed a change in the manner the government should identify drugs to be brought under price control. 26 May 2017
Pharmaceutical
America’s Merck & Co is to collaborate with health services company Optum to draft reimbursement models driven by health outcomes data. 26 May 2017
Pharmaceutical
The UK Competition and Markets Authority (CMA) today issued a statement of objections to the pharmaceutical company Merck Sharp & Dohme (MSD). 23 May 2017
Generics
Prices for drugs from low and middle-priced segments of the Russian market may increase significantly this year, due to plans of the government to change the scheme of pricing for such categories of drugs, starting from January 1, 2018, reports The Pharma Letter’s local correspondent. 19 May 2017
Pharmaceutical
Major drug makers in India are in a soup. It is not just the US Food and Drug Administration that is cracking the whip given its three-fold increase in scrutiny of pharma units, the National Pharmaceutical Pricing Authority (NPPA) has issued ‘show cause’ notices to 67 drug companies for introducing certain new brands without price approval, reports The Pharma Letter’s India correspondent. 18 May 2017
Pharmaceutical
Russia may be faced with a shortage of drugs in the future, due to the forthcoming transition to a new system of drug labeling that may lead to huge interruption in medicines supplies to the country. 18 May 2017
Pharmaceutical
American lawmakers are reintroducing a bill that would limit the ability of pharmaceutical companies to raise drug prices, with tougher language to prevent medium-term hikes. 16 May 2017
Biotechnology
In non-small cell lung cancer (NSCLC) that has already formed metastases, the suitable treatment depends, among other factors, on the genes that are activated in the tumor cells and whether mutations have occurred that make certain treatments ineffective. 16 May 2017
Generics
South African drugmaker Aspen Pharma has confirmed that the European Commission has opened proceedings to investigate certain actions of Aspen Holdings and certain of its European subsidiaries. 16 May 2017
Biotechnology
The USA’s Institute for Clinical and Economic Review (ICER), a non-profit organization, has released an Evidence Report assessing the comparative clinical effectiveness and value of dupilumab and crisaborole for the treatment of atopic dermatitis. 14 May 2017
Pharmaceutical
The World Health Organization (WHO) has held a forum on the cost of medicines in a stated attempt to facilitate discussion leading to ‘fairer price setting and a system that is sustainable for health systems and for innovation’. 12 May 2017
Pharmaceutical
A clinical trial has found that the oncology drug Avastin (bevacizumab) is about as effective as Eylea (aflibercept) in treating central retinal vein occlusion (CRVO), an eye condition. 11 May 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued a second Appraisal Consultation Document (ACD) not recommending the routine National Health Service use of Venclexta (venetoclax) for patients with certain types of difficult-to-treat relapsed and refractory chronic lymphocytic leukemia (CLL). 11 May 2017
Pharmaceutical
Figures from pharma are used to attempt to explain the complexities of an industry where public perception does not always reflect the reality, and such was the evident motivation in a letter written by Richard Torbett, the Association of the British Pharmaceutical Industry (ABPI) executive director, UK commercial. 10 May 2017
Pharmaceutical
Olivier Brandicourt, the chief executive of French pharma major Sanofi, has written an open letter promising to limit the company’s US price rises. 10 May 2017
Pharmaceutical
The leading pharma lobby group in the USA has been working to defend drug prices at home in recent months amid President Donald Trump’s tough talk about targeting drugmakers, but with a patriotic tone that could have come from the man himself, it has now criticized other countries for not paying adequately for US innovation. 10 May 2017
Pharmaceutical
Johnson & Johnson revealed in a filing with the Securities and Exchange Commission (SEC) that the US Justice Department has opened an investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that bought its drugs. 9 May 2017
Pharmaceutical
The Australian government has reached a major agreement with the pharmaceutical industry related to drug prices and the Pharmaceutical Benefits Scheme (PBS). 9 May 2017
Pharmaceutical
The latest annual report from the trade body of New Zealand’s pharmaceutical industry highlights some of the challenges facing the sector. 8 May 2017
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