Pricing, reimbursement and access
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Generics
Price hikes and new launches are to push the growth of the Indian pharma market in the coming months. 8 April 2021
Pharmaceutical
Paul Hudson, chief executive of French pharma major Sanofi today outlined several key projects that the company will implement to increase the impact of its corporate social responsibility (CSR) strategy. 7 April 2021
Generics
The Brazilian Supreme Court of Justice is expected to deliver a potentially ground-breaking verdict on the constitutionality of a provision in the country’s intellectual property (IP) law allowing patent term extensions this week, according to Médecins Sans Frontières (MSF). 6 April 2021
Biotechnology
The Institute for Clinical and Economic Review (ICER) has released an evidence report comparing clinical effectiveness and value of three new treatments targeting the B-cell maturation antigen (BCMA) for heavily pre-treated patients with triple class refractory multiple myeloma (TCRMM). 6 April 2021
Biotechnology
Breast cancer patients undergoing chemotherapy will be offered a new combined treatment, Phesgo, which is injected and takes as little as five minutes to prepare and administer, compared with two infusions that can take up to two and a half hours, NHS England has announced. 6 April 2021
Pharmaceutical
Multinational companies (MNCs) must evolve their strategies with a fast-paced China to succeed in the highly competitive market, said company representatives at the two-day 2021 China healthcare investment conference on March 24 in Shanghai. 6 April 2021
Biotechnology
The UK’s National Institute for Care and Health Excellence (NICE) has recommended Ondexxya (recommend andexanet alfa) for reversing anticoagulation of the direct factor Xa (FXa) inhibitors apixaban or rivaroxaban in adult patients who experience a life-threatening or uncontrolled bleed in the gastrointestinal (GI) tract, US drugmaker Alexion Pharmaceuticals announced today. 1 April 2021
Biotechnology
Three years after launching in the UK, Swedish Orphan Biovitrum's Kineret (anakinra) has secured a positive reimbursement decision from the country’s health technology assessor. 1 April 2021
Biosimilars
Biosimilar medicines are increasingly relevant to public health as emphasised by the new Pharmaceutical Strategy for Europe. 31 March 2021
Generics
As the call for compulsory licenses on two new tuberculosis (TB) drugs gets louder in India, the Bombay High Court has directed the government to decide on the representations made seeking non-commercial licenses for the two patented life-saving anti TB drugs: bedaquiline and delamanid, which offer fresh hope to multi-drug resistant (MDR) or extensive-drug resistant (XDR) TB patients. 30 March 2021
Pharmaceutical
The Delhi High Court in India has set out three major directives with regard to patients suffering from rare diseases. 29 March 2021
Biotechnology
The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include AVEO Oncology’s Fotivda (tivozanib) as a recommended regimen for subsequent therapy. 29 March 2021
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Breyanzi (lisocabtagene maraleucel: liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma and R/R follicular lymphoma. 26 March 2021
Pharmaceutical
Medicines to treat infectious diseases and inflammatory disorder, as well as cancers, Alzheimer’s and rare diseases that collectively affect millions of people are under development by pharma and biotech, but the problem now is to deliver them to patients. 26 March 2021
Pharmaceutical
According to a summary published by the Hungarian Association of Innovative Pharmaceutical Manufacturers (AIPM) on the occasion of the Rare Disease Day, increasingly effective innovative therapies present a new opportunity for patients. 22 March 2021
Biotechnology
The oral targeted cancer therapy Calquence (acalabrutinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine use within NHS England as a treatment for chronic lymphocytic leukemia (CLL). 18 March 2021
Generics
India's drug pricing regulatory agency, the National Pharmaceutical Pricing Authority (NPPA), has extended the revised ceiling price of Heparin Injection up to September 2021. The rising costs of raw materials from China has pushed the NPPA to take this decision. 18 March 2021
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending the provision of Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ ezetimibe) on the National Health Service (NHS) in England. 18 March 2021
Biosimilars
As India's Biocon Biologics partners pharma giants Novartis and Pfizer to enhance access to life-saving cancer drugs for patients, especially in Sub-Saharan and Asian regions, several Indian drug majors are ponying up to ensure easy access to top cancer drugs, reports The Pharma Letter’s India correspondent. 15 March 2021
Biotechnology
The USA’s health technology assessor, the Institute for Clinical and Economic Review (ICER) has released a largely positive Evidence Report assessing the comparative clinical effectiveness and value of UK-based GlaxoSmithKline’s Benlysta (belimumab) and Canada’s Aurinia Pharmaceuticals’ Lupkynis (voclosporin) for the treatment of lupus nephritis (LN). 13 March 2021
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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