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Pharmaceutical
Over the past 24 months, the Latin American cannabis industry has emerged from the shadows to command the attention of the international cannabis community as over ten major markets have legalized medical cannabis. 8 October 2018
Biotechnology
A month after the UK's National Health Service (NHS) agreed a deal to make Novartis’ Kymriah (axicabtagene ciloleucel) available to children and young people with a rare form of leukemia, a deal has been announced to bring another CAR-T therapy to English patients. 5 October 2018
Pharmaceutical
According to a new report by IQVIA Institute for Human Data Science, more and more patients are asked to pay high cost sharing due to changes in benefit design. 5 October 2018
Biotechnology
The Australian government has announced that it will make a drug for severe inflammatory spinal arthritis more affordable when it is listed on the Pharmaceutical Benefits Scheme (PBS), saving patients more than A$15,000 ($10,870) a year. 4 October 2018
Generics
The pharmaceutical intellectual property aspects of the United States-Mexico-Canada Agreement (USMCA), which was agreed on Monday to replace the former North American Free Trade Agreement (NAFTA) accord, have come in for criticism from the Canadian Generic Pharmaceutical Association (CGPA). 2 October 2018
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC has announced a decision to list sapropterin (trade name Kuvan), a treatment for the rare condition phenylketonuria (PKU), for women who are pregnant or actively planning a pregnancy and require pharmacological support to manage PKU in pregnancy. 1 October 2018
Biotechnology
With its molecular-targeted radio-therapy Iomab-B showing promise and in a pivotal Phase III for bone marrow transplant, USA-based Actinium Pharmaceuticals has initiated a program to use lower dose (Iomab-ACT) to boost safety and efficacy of the much vaunted CAR-T therapy in blood cancers, comments Dr Chris Redhead, an analyst at Goetzpartners Securities Research. 28 September 2018
Biosimilars
The US trade group for generics and biosimilars companies has underlined the steps that the US Food and Drug Administration (FDA) can take to further the adoption of affordable copies of expensive biologic medicines. 28 September 2018
Pharmaceutical
A week after a UK court judged that bevacizumab injections could be prescribed for the treatment of wet age-related macular degeneration (wet AMD), German life sciences group Bayer has appealed against the decision. 28 September 2018
Pharmaceutical
A mandated price drop is about to come into effect in Australia on 226 medicine brands listed on the Pharmaceutical Benefits Scheme (PBS). 27 September 2018
Biosimilars
The worth of the global biosimilars market will have risen from its $4.36 billion 2016 value by 34% at compound annual growth rate to nearly $20 billion by 2025, a study has predicted. 27 September 2018
Pharmaceutical
The world’s largest healthcare plan has been launched by Indian Prime Minister Narendra Modi, providing free or subsidized coverage for the poorest 40% of India’s population. 27 September 2018
Biotechnology
The USA’s Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report assessing the clinical effectiveness and value of biologic treatments for asthma associated with Type 2 inflammation and/or allergic asthma. The draft report will be open to public comment until October 22, 2018. 26 September 2018
Generics
With mounting legal challenges to its hepatitis C patent estate abroad, and rising competition at home, California’s Gilead Sciences has decided to get ahead of the game and launch its own approved generics for Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir). 25 September 2018
Biotechnology
A High Court case win by 12 National Health Service (NHS) Clinical Commissioning Groups (CCGs) in favor of prescribing the significantly cheaper anti-vascular endothelial growth factor (anti-VEGF), Avastin (bevacizumab), over Novartis’ (NOVN: VX) and Bayer’s (BAYN: DE) licensed anti-VEGF eye drugs has import implications, says analyst. 24 September 2018
Biotechnology
With CAR-T therapies closer than ever to delivering on their promise but still facing significant obstacles, Eva Marchese and Cécile Matthews from Charles River Associates provide an Expert View on the topic. 24 September 2018
Biotechnology
When Novartis’ Kymriah (tisagenlecleucel) was made available to a small group of young patients in an agreement with NHS England less than a month ago, the decision came just 10 days after the drug was approved in Europe. 23 September 2018
Pharmaceutical
German pharma major Bayer has hit out at a UK court’s judgement that it is potentially lawful to offer patients bevacizumab injections for the treatment of wet age-related macular degeneration (wet AMD). 21 September 2018
Biotechnology
A few short months after Merck & Co won its first Chinese approval for flagship immuno-oncology product Keytruda (pembrolizumab), the firm has reportedly agreed a price reduction plan that will enable patients to gain access for around half the US list price. 20 September 2018
Biosimilars
The prospect of reducing treatment costs for payors supports a positive future for biosimilars, according to new research released today. 20 September 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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