Pricing, reimbursement and access
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Pharmaceutical
Cost-effectiveness watchdog for England and Wales the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending cabazitaxel, which is marketed as Jevtana by French pharma major Sanofi, for some prostate cancer patients. 22 April 2016
Biotechnology
based Actelion reported net income for the first quarter of 2016 was 178 million Swiss francs ($184 million), up 12% from 159 million francs a year ago but below the poll average of 188 million francs. 22 April 2016
Biotechnology
What is behind hepatitis C virus (HCV) drug Harvoni (ledipasvir/sofosbuvir) coming top of a list showing the medicines which accounted for the highest cumulative spending by US patients in 2015? 21 April 2016
Pharmaceutical
After its assessment in 2013, the German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed the added benefit of Xalkori (crizotinib) in comparison with the appropriate comparator therapy, concluded that an added benefit of crizotinib for the first-line treatment of advanced bronchial carcinoma is not proven. 19 April 2016
Biotechnology
Despite the setbacks in the global markets since the beginning of 2016, the valuations of biotechnology companies remain attractive in comparison to the S&P and are based on strong fundamentals, says Carl Harald Janson, investment manager at SV Life Sciences Managers. 19 April 2016
Pharmaceutical
Activist fund Starboard Value targeted Depomed, a small drug maker with an approximate $1 billion market capitalization late last week, wrote Bret Jensen, a regular contributor to the Seeking Alpha blog. 17 April 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) on Friday recommended Translarna (ataluren), from US pharma company PTC Therapeutics for treating children aged five and over with Duchenne muscular dystrophy (DMD) caused by a nonsense mutation. 16 April 2016
Pharmaceutical
Spending on medicines in the USA increased by double digits for a second year in 2015, reaching $425 billion based on invoice prices. 14 April 2016
Biotechnology
Ono Pharmaceutical has released sales projections for its new cancer drug Opdivo (nivolumab). 12 April 2016
Pharmaceutical
The USA ranks 1st in how its domestic policies support worldwide life sciences innovation, according to an analysis released last week by the Information Technology and Innovation Foundation (ITIF), a global technology policy think tank. 11 April 2016
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in an early benefit assessment whether Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide) offers an added benefit for patients in comparison with the appropriate comparator therapy treatment for adults and adolescents infected with HIV-1. 11 April 2016
Pharmaceutical
The Russian Federal Antimonopoly Service (FAS) plans to initiate proceedings against some foreign drug manufacturers operating in the Russian market, on the suspicion of price-fixing and cartel formation. 9 April 2016
Biotechnology
US biotech firm Celgene expressed disappointment with a draft decision issued today by the drug cost-effectiveness watchdog for England, the National Institute for Health and Care Excellence (NICE). 8 April 2016
Pharmaceutical
A number of barriers are impeding access to insulin around the world, according to new research published today by Health Action International, Geneva University Hospitals/University of Geneva and Boston University School of Public Health. 7 April 2016
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has completed its examination of Swedish Orphan Biovitrum’s Elocta (efmoroctocog alfa), assessing whether this new drug offers an added benefit over the appropriate comparator therapy both in prevention and in on-demand treatment for people with hemophilia A. 7 April 2016
Pharmaceutical
The Australian Minister for Health, Sussan Ley, has announced that patients will see the cost of their prescriptions for common medicines drop by as much as 60% as part of government reforms. 4 April 2016
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) examination of Janssen’s HIV treatment Edurant (rilpivirine) finds no added benefit. 4 April 2016
Generics
The US Generic Pharmaceutical Association (GPhA) and America’s Health Insurance Plans (AHIP) have filed an amicus brief urging the Supreme Court to preserve the inter partes review (IPR) process in promoting a competitive prescription drug market for consumers. 1 April 2016
Pharmaceutical
If you believe you know all there is to know about Japan’s pharma market, it is time for a refresher course. 30 March 2016
Pharmaceutical
US Congress has written to the National Institutes of Health (NIH) questioning the price Americans are charged for the prostate cancer drug Xtandi (enzalutamide) by Japanese company Astellas Pharma. 30 March 2016
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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