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Pharmaceutical
A winning strategy in the Japan pharma market cannot be conceived or implemented by those who are ignorant of what moves the market. Cloning a strategy that worked elsewhere may not necessarily work in Japan, thus causing a high level of frustration for foreign company executives, writes long-time Japan pharma watcher and president of International Alliances Limited P Reed Maurer in his exclusive column for The Pharma Letter. 19 December 2018
Pharmaceutical
Pharma trade group Medicines Australia has welcomed today’s Mid-Year Economic and Fiscal Outlook (MYEFO), announced by Treasurer Josh Frydenberg. 17 December 2018
Pharmaceutical
The downturn seen in the pharma and biotech sectors in the past few months of 2018 looks set to continue into 2019, with investors in the industry likely to become more cautious. 13 December 2018
Pharmaceutical
Cost-effectiveness watchdog ICER has issued a document introducing a new metric to its assessment toolbox, the Equal Value of Life Years Gained (evLYG). 13 December 2018
Pharmaceutical
The Russian government has adopted a new method for determining the prices for vital and essential drugs, according to an official spokesman of Russian Minister of Health Veronika Skvortsova, reports The Pharma Letter’s local correspondent. 13 December 2018
Biotechnology
Following its acceptance in the UK’s Cancer Drug Fund in October, the medicines cost-effectiveness watchdog has now agreed to the regular NHS England funding of Yescarta (axicabtagene ciloleucel). 7 December 2018
Biotechnology
Johnson & Johnson subsidiary Actelion has agreed to pay $360 million to resolve claims that it illegally used a foundation as a conduit to pay the co-pays of thousands of Medicare patients taking Actelion’s pulmonary arterial hypertension drugs, in violation of the False Claims Act, the US Department of Justice announced yesterday. 7 December 2018
Pharmaceutical
The well-documented case of Medicaid being overcharged over EpiPen (epinephrine), the emergency allergy treatment from Mylan, has led two Senators to propose a bipartisan bill. 5 December 2018
Pharmaceutical
The worth of extended-release treatments for opioid use disorder has been questioned in analysis from the Institute for Clinical and Economic Review (ICER). 4 December 2018
Pharmaceutical
The Australian government will list new medicines for severe asthma and growth hormone deficiency on its Pharmaceutical Benefits Scheme (PBS). 3 December 2018
Biotechnology
UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending the reimbursement within the Cancer Drugs Fund (CDF) of the immunotherapy, Opdivo (nivolumab), as adjuvant treatment after surgery, to potentially keep the cancer from returning. 30 November 2018
Pharmaceutical
A coalition of 55 Conservative groups and activists have voiced major concerns at President Donald Trump’s proposals on Medicare drug prices. 29 November 2018
Biotechnology
The first children in the UK to receive a game-changing personalized therapy for cancer will start treatment at Great Ormond Street Hospital in London this week, NHS England announced yesterday. 28 November 2018
Pharmaceutical
A research note from industry analyst GlobalData concludes that India’s new national insurance scheme Ayushman Bharat has potential to be a “game changer,” while warning that there are “policy issues which need to be addressed by the government to make it sustainable for all the stakeholders.” 27 November 2018
Biosimilars
The NHS is set to save a record £300 million ($384 million) after negotiating deals with five manufacturers on low cost versions of the health service’s most costly drug, NHS England chief executive Simon Stevens announced today. 27 November 2018
Pharmaceutical
New rules proposed by the administration of US President Donald Trump would see insurers participating in the government-backed Medicare scheme permitted to exclude pharmaceuticals if price rises outpaced inflation. 27 November 2018
Pharmaceutical
At a time when the sector is engulfed in Brexit uncertainty, some rare good news has been announced for drugmakers and patients in the UK. 23 November 2018
Generics
The 2nd Value Added Medicines conference, which took place in Brussels, Belgium, yesterday, gathered a wide range of experts in the healthcare community to raise awareness, informed debate with the mutual intention to present solutions for maximizing the benefits of and encouraging the development of continuous innovation. 22 November 2018
Biotechnology
British cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) that recommends inclusion of Keytruda (pembrolizumab) in the Cancer Drugs Fund (CDF) in lung cancer. 22 November 2018
Pharmaceutical
New, draconian measures aimed at lowering drug prices by preventing drug companies from exceeding certain price thresholds have been proposed in the US Senate. 21 November 2018
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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