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Biotechnology
The Russian Ministry of Health has approved the use of Zolgensma (onasemnogene abeparvovec), the world’s most expensive drug against spinal muscular atrophy (SMA) in the domestic market, reports The Pharma Letter’s local correspondent. 22 December 2021
Biotechnology
In March 2021, the US Food and Drug Administration (FDA) announced its continued support for rare disease programs.1 So far, giant strides have been made in the search to find cures for diseases that affect a small percentage of the population, but are devastating in effect. 21 December 2021
Pharmaceutical
The year 2021 saw the US Food and Drug Administration approval of 46 novel drugs,1 80 first generics,2 two biosimilars,3 and nine novel biologics,4 as of December 10, 2021. In addition to the regulatory approval of therapeutics, the FDA has been addressing many other pressing public health concerns. We take a brief look at some of the FDA’s activities this year. 18 December 2021
Pharmaceutical
The Russian drugmaker R-Pharm topped the rating of pharmaceutical manufacturers in Russia that made the biggest profits from public procurements of anti-COVID-19 drugs by the state for first 10 months of the current year, according to a recent study conducted by DSM Group, one of Russia’s leading analyst agencies in the field of pharmaceuticals, reports The Pharma Letter’s local correspondent. 15 December 2021
Generics
Supply chain disruptions, quality concerns and abrupt price hikes have been some of the issues resulting from over-dependency on a single source for supplies of life-saving drugs and other key raw materials. To mitigate risks associated with over-dependency on other nations, India's Health Minister Mansukh Mandaviya says the focus is to build self-reliance and promote the domestic pharmaceutical manufacturing industry, despite the decision to shut down two pharma public sector undertakings and disinvest three others, reports The Pharma Letter’s India correspondent. 9 December 2021
Pharmaceutical
The Russian government will allocate about 62 billion roubles ($840 million) in 2022 for the procurements of high-priced drugs as part of the 14 high-cost nosologies (14 VZN) program, a state program, which involves procurements of the most expensive drugs for state needs in Russia, reports The Pharma Letter’s local correspondent. 7 December 2021
Pharmaceutical
The updated Chinese national drug reimbursement list, released on December 3 by the National Healthcare security Administration (NHSA), showed clearly that China wants more affordable rare disease drugs and innovative cancer drugs, reports The Pharma Letter’s local correspondent. 6 December 2021
Generics
The key issue when prescribing generic drugs in India is quality, not price, with Indian doctors relying on the reputation of companies that have demonstrated their commitment to quality over time. A new study has found that the perceived difference in the quality of various brands of generic drugs that can be prescribed interchangeably is one of the major barriers to effective price competition in India's drug market, reports The Pharma Letter’s India correspondent. 2 December 2021
Biotechnology
Chinese biotechs used to prefer late-clinical stage assets when seeking in-licensing targets for a quick launch in China, but this is no longer the case. 1 December 2021
Pharmaceutical
Russia is getting closer to the completion of development of one of the world’s first drugs against COVID-19, according to recent statements by the Russian Health Minister Mikhail Murashko and some local media, reports The Pharma Letter’s local correspondent.
November 23, 2021 30 November 2021
Pharmaceutical
Russia will continue to depend on imports of radiopharmaceuticals in the coming years, as the launch of its own production of such drugs will be suspended for an indefinite period of time, reports The Pharma Letter’s local correspondent. 29 November 2021
Pharmaceutical
Multinationals corporations (MNCs) have been actively adding China to their multicenter global clinical studies in recent years, it was made clear at a recent meeting. 24 November 2021
Pharmaceutical
November 17th was Smith-Magenis syndrome (SMS) Awareness Day. We take a look at this complex development disorder and advances in pharmacological treatments for the condition. 23 November 2021
Generics
The Russian government plans to conduct a pilot project in the domestic pharmaceutical sector that will involve conducting state procurements of drugs manufactured by companies that have a full-cycle production in one of the countries of the Eurasian Economic Union (EAEU). 23 November 2021
Biosimilars
Typically, in the USA, the list prices of biosimilars at launch have been 15% to 35% lower than that of the corresponding reference products, and the biosimilar market is estimated to lead to savings of $133 billion over the next five years.1,2 22 November 2021
Biotechnology
China’s biotech industry enjoyed significant growth in the past several years, but major bottlenecks are looming as Chinese biotechs aims for a global expansion, said speakers at the two-day event Chinatrials on November 11 in Shanghai. 17 November 2021
Generics
German drugmaker STADA Arzneimittel plans to continue an active development in the Russian pharmaceutical market in the coming years, considering it as one of the most promising for its further growth, reports The Pharma Letter’s local correspondent. 16 November 2021
Biosimilars
Eager to create an ecosystem for innovation, a draft policy document prepared by India's Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers has proposed to cut down the time taken for regulatory approvals for innovative products by at least 50% within the next two years. The policy aims to catalyze R&D in the pharma and medtech sector, and to propel India to become a leader in drug discovery through incubating an entrepreneurial environment, reports The Pharma Letter’s India correspondent. 10 November 2021
Pharmaceutical
The COVID-19 pandemic generated multiple challenges for the Latin American pharmaceutical industry, especially in matters of codes of ethics and crisis management. 8 November 2021
Pharmaceutical
Russia is increasing exports of its anti-COVID-19 vaccines this year, with the biggest markets being Argentina, Kazakhstan and India, reports The Pharma Letter’s local correspondent. 8 November 2021
Pharmaceutical
Big pharmas are not deterred by China’s increasingly complex business environment. Instead, they are changing strategies to minimize risks while continuing to benefit from China, said speakers at ChinaTrials held last week in Shanghai. 18 November 2024
Generics
Indian drugmaker Aurobindo Pharma has taken on the might of China in terms of Penicillin G pricing, and is doing so by leveraging a fully integrated production process at its new plant. Anticipating the price erosion of Penicillin G, the company has put up an integrated plant from scratch. 10 November 2024
Generics
Indian markets are abuzz with a singular refrain. Donald Trump's Presidency of the United States is set to open new opportunities for India, especially in the pharmaceutical sector. 8 November 2024
Biotechnology
According to UNICEF's State of the World's Children 2023 report, in Latin America
and the Caribbean, 6.8 million children did not benefit from vaccination during the
time of the pandemic and in the following two years, progress has not been as
expected either. 7 November 2024
Biotechnology
As India's bioeconomy soars to a remarkable valuation of $151 billion, the government's Biotechnology Industry Research Assistance Council (BIRAC) has underscored the critical need for innovation and private sector investment to unlock further growth. 21 October 2024
Biotechnology
India's new Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) scheme is a significant step towards consolidating and advancing the country's biotechnology initiative. 7 October 2024
Pharmaceutical
India is set to complete 50 new greenfield pharma manufacturing plants in the next two years under its Production-linked Incentive (PLI) scheme for pharma and medical devices. 30 September 2024
Generics
The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter’s local correspondent. 30 September 2024
Pharmaceutical
Pharmaceutical laboratories, institutions, guilds and medical federations have taken on the task of designing programs to end health illiteracy in order to have informed, educated, knowledgeable and empowered communities where their health and wellbeing are concerned. 19 September 2024
Pharmaceutical
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
Generics
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
Pharmaceutical
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024
Biotechnology
NewCo, a relatively new business model that involves a joint venture (JV) between a biotech and a group of investors to bring the biotech’s promising assets to the global market, is gaining popularity among Chinese biotechs, who traditionally rely on out-licensing deals to capitalize assets, s 11 September 2024
Generics
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
Biotechnology
Targeted alpha therapy (TAT), or radioligand therapy, is a recent hot area that attracted big pharmas like Bristol Myers Squibb and Novartis. 5 September 2024
Generics
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
Pharmaceutical
Scientists from the Russian Institute of Immunology of the Federal Medical and Biological Agency (FMBA) say they have created the world's first allergy vaccine. 30 August 2024
Generics
In a major crackdown, the Indian government has imposed an immediate ban on 156 fixed-dose combination (FDC) drugs, including commonly used antibiotics, pain relievers,and multivitamins. 27 August 2024
Pharmaceutical
Russia plans to create conditions for a significant increase of domestic production of anti-Rhesus immunoglobulin drugs after a sharp decrease of their imports to the local market this year, reports The Pharma Letter’s local correspondent. 22 August 2024
Generics
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
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