Health reform in Turkey and inclusive policies
Songül Çınaroğlu in Equity and Healthcare Reform in Developing Economies, 2020
Turkey has been criticized for its lack of transparency in pricing and reimbursement strategies in the pharmaceutical industry. And, lack of communication with the pharmaceutical industry is another criticized area (Varol and Saka, 2006). In Turkey, the development of the pharmaceutical industry parallels economic growth and industrializations (Vural, 2017). During the 1980s, privatizations and liberalizations of trade and services, including the health sector, gained prominence in Turkey (Semin and Guldal, 2008). After completing the Customs Union with the EU in 1996, Turkey began cooperating with the international pharmaceutical industry. This increased market sales along with original and licensed product sales and values (Vural, 2017).
How should medicine develop?
Jim Connelly, Chris Worth in Making Sense of Public Health Medicine, 2018
The ‘establishment’ within medicine reinforces the ‘common sense’ view of medicine. The popular and medical trade media are replete with ‘break throughs’, ‘startling new discoveries’ and stories of ‘new hope for _________ sufferers’ (fill in the blank with a disease of your choice). The pharmaceutical industry is worth billions of pounds and comprises some of the world’s largest multi-national corporations. Certainly there are great vested interests in drug development, and in ensuring that these drugs are prescribed and represcribed. The academic institutions participate in the social ideology by their strictures on ways to knowledge and by privileging those types of research effort which reflect what it sees as important. The prestigious research councils announce yet more money available to molecular geneticists, who are asked to use their ‘big science’ to solve problems like obesity, delinquency, aggression and drug dependence. But why are the most obvious facts regarding health and disease overlooked or marginalized?
Impact of Platform Trials on Pharmaceutical Frameworks
Zoran Antonijevic, Robert A. Beckman in Platform Trial Designs in Drug Development, 2018
The pharmaceutical industry is experiencing great challenges in trying to maintain their profitability. Most governments and private payers are increasingly challenging pricing of approved products. As a result of this trend we are seeing that sponsors are trying to maximize efficiency of product development. There is an increased focus on quantitative methodologies and optimization, as well as an increased interest in the utilization of platform trials as a replacement to series of independent trials, where applicable. While relevant methods have been developed, more work on proper implementation of these methods and concepts is needed. This chapter will define Pharmaceutical Frameworks (PF) and specify how Platform Trials fit there. First, the concept of PF and its elements will be described in a format of a glossary where related concepts are prospectively defined. At the high level, the role of PFs is to provide elements and procedures that enable optimization at the Pharmaceutical program and portfolio levels. Most concepts mentioned in this chapter are not necessarily new, the greater focus is on describing procedures necessary for implementation of these concepts. Finally, for the purpose of this book the chapter explains how to set-up PFs that involve Platform Trials.
Are patents important indicators of innovation for Chagas disease treatment?
Published in Expert Opinion on Therapeutic Patents, 2023
Andrea Pestana Caroli, Felipe R. P. Mansoldo, Veronica S. Cardoso, Celso Luiz Salgueiro Lage, Flavia L. Carmo, Claudiu T Supuran, Alane Beatriz Vermelho
Several bottlenecks are found and discussed in several reviews of literature, such as lack of investments from the government, the low interest of the large pharmaceutical laboratories despite the growing participation, difficulties in the translational processes, and lack of integration between academia and industry for the development of clinical studies are among the main factors [106–109]. For neglected diseases, the economics of developing a drug is unfavorable. Due to this low investment in drugs to treat diseases predominantly in low- and middle-income countries, the pharmaceutical industry invests in market drugs. According to Lexchin, 2021 [110], in 2000 and 2011, 336 new chemical entities were registered worldwide, and only four were approved for neglected diseases. In addition, 1% of the 148,445 clinical trials registered at the end of 2011 were focused on neglected diseases [111].
Developments and opportunities in continuous biopharmaceutical manufacturing
Published in mAbs, 2021
Ohnmar Khanal, Abraham M. Lenhoff
The pharmaceutical industry is among the most conservative sectors, due in large part to regulatory and product safety considerations, and innovation often occurs via mergers and acquisitions of smaller companies and start-ups.5 Although the first recombinant biologic emerged in 1982, the biopharmaceutical industry has yet to manufacture affordable drugs at the maximum possible efficiency. Process innovation has been slow, partially stemming from limited drug-price regulation in the US. Given this autonomy and the high costs of other factors, such as clinical trials, in drug development, pharmaceutical companies have worked more to bring products to market quickly than to lower the cost of manufacturing.6 To increase biologics affordability, both Europe and the US created approval pathways for biosimilars more than 10 years ago. Several dozen biosimilar products had been approved for use in those two jurisdictions as of mid-2020, but a general observation is that the savings afforded by these biosimilars have been relatively limited;7–9 the economic incentive for biosimilar development in the US is “currently unstable”.10
Why do few drug delivery systems to combat neglected tropical diseases reach the market? An analysis from the technology’s stages
Published in Expert Opinion on Therapeutic Patents, 2022
Jabson Herber Profiro de Oliveira, Igor Eduardo Silva Arruda, José Izak Ribeiro de Araújo, Luise Lopes Chaves, Mônica Felts de La Rocca Soares, José Lamartine Soares-Sobrinho
According to the Pharmaceutical Drug Delivery Market report for 2018, the pharmaceutical industry’s niche market for DDSs was valued at $ 1 billion, with the projection that it will reach $ 1.733 billion by 2026. This segment of the pharmaceutical industry consists of a wide presence in the sale of medicines for chronic diseases (e.g. cancer, diabetes, and cardiovascular diseases) and dominated by large laboratories such as Bayer AG, Becton, Dickinson and Company, F. Hoffmann-La Roche AG, GlaxoSmithKline Plc, Johnson & Johnson, Merck & Co., Inc., Novartis AG, 3 M Company, Pfizer Inc., and Sanofi [169]. This market is characterized by the type of technology associated (e.g. activation modulated, micro-reservoir feedback regulated, partition controlled, polymer matrix systems, and chemically activated systems), and by the routes of administration (e.g. oral, topical, nasal, ocular, and others) [169,185].
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