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Pharmaceutical
Genetic differences among racial and ethnic populations can lead to differences in the safety and efficacy of drugs across these populations. The US Food and Drug Administration approves medical products based on evidence from clinical trials and so participants in clinical trials should adequately represent the population intended to use the product. 20 May 2022
Generics
Along with all the other medicines supply problems that the country has recently encountered, Russia is now facing a shortage of anti-HIV drugs, despite a significant increase of their procurements by the state in recent years, reports The Pharma Letter’s local correspondent. 18 May 2022
Generics
Indian pharmaceutical companies are concerned about the increase in warning letters and OAIs (official action indicated) from the US Food and Drug Administration, which could potentially delay product launches and can push up regulatory uncertainty and compliance costs. As the number of US FDA inspections increases, so does the number of good manufacturing practices ( 17 May 2022
Generics
Russian drug manufacturers and laboratories are faced with serious shortage of excipients, which is mainly due to serious interruptions in their deliveries to the Russian market, reports The Pharma Letter’s local correspondent. 12 May 2022
Pharmaceutical
The refusal of large pharmaceutical manufacturers to conduct their clinical trials in Russia threatens local specialized centers with the loss of almost half of potential contracts, according to recent statements by some local analysts in the field of pharmaceutics and Russian media reports, reports The Pharma Letter’s local correspondent. 4 May 2022
Pharmaceutical
None of the global drugmakers operating in the Russian market has announced plans to terminate the supplies of their drugs to the country, according to recent statements by an official spokesman of the Russian healthcare regulator Roszdravnadzor, while some of them are even considering the increase of supplies, reports The Pharma Letter’s local correspondent. 4 May 2022
Generics
India continues to establish itself as the pharmacy of the world as exports swell by 103% since 2013-14. The pharmaceutical industry is now being urged to work toward becoming the healthcare custodian of the world by adhering to good manufacturing practices, reports The Pharma Letter’s India correspondent. 3 May 2022
Biotechnology
Fibrodysplasia ossificans progressiva (FOP) is a rare connective tissue disease characterized by heterotopic ossification, where bone growth occurs in areas where bone typically should not be present.1 30 April 2022
Pharmaceutical
The Russian government will allocate additional 23 billion roubles ($305 million) for the procurements of high-priced imported drugs as part of 14 high-cost nosologies (VZN) state program, reports The Pharma Letter’s local correspondent. 25 April 2022
Generics
India is well on its way to becoming a global hub for pharmaceuticals. Around 35 active pharmaceutical ingredients (API), which were previously imported into India, are now being manufactured across the country. Applied research for investigational new drugs has also quadrupled in India, reports The Pharma Letter’s India correspondent. 21 April 2022
Pharmaceutical
The Russian Ministry of Health has prepared a list of 39 anticancer drugs that are likely to be in short supply in the country due to ongoing military conflict between Ukraine and Russia and Western sanctions imposed on Russia, reports The Pharma Letter’s local correspondent. 7 April 2022
Pharmaceutical
India's TB Prevalence Survey 2019-2021, the first of its kind in the country in 55 years, has found that tuberculosis (TB) is more prevalent in India than previously thought. 31 March 2022
article
The Ministry of Health has begun collecting data on drugs that are not produced in Russia as well as a number of “friendly” countries as part of its efforts to prevention their shortage in the domestic market, according to recent statements by an official spokesman of the Ministry and local media, reports The Pharma Letter’s local correspondent. 30 March 2022
Pharmaceutical
March is Wilson disease awareness month – an autosomal recessive genetic disorder characterized by excess copper accumulation in the body.1 It is caused by a mutation in the ATP7B gene, with an estimated one in 90 people carrying the mutation.1 29 March 2022
Pharmaceutical
On February 17, 2022, Dr Robert Califf was sworn in as US Food and Drug Administration Commissioner for the second time; his first term was from February 2016 to January 2017, under the Obama administration. 28 March 2022
Biosimilars
China’s Fosun Pharma’s biotech arm Henlius is preparing to get its PD1 antibody serplulimab into hospitals nationwide once it is approved in China, and supply its four approved biosimilars with enhanced manufacturing capacity, said Henlius chief executive Zhang Wenjie at a press meeting held in Shanghai on March 17. 22 March 2022
Pharmaceutical
Innovative treatments and medicines developed by the pharmaceutical industry in Latin America not only save lives, but also create jobs, help reduce health spending and raise quality of life standards, The Pharma Letter’s local correspondent writes. 22 March 2022
Generics
Indian generic players may soon have access to a blockbuster cancer drug. The loss of exclusivity in the USA for Bristol Myers Squibb's Revlimid (lenalidomide) is helping several generic players to seek huge gains, with some in India entering unique settlements, reports The Pharma Letter’s India correspondent. 21 March 2022
Pharmaceutical
Due to Russia’s military invasion of the Ukraine, global pharma companies are massively refusing to conduct clinical trials of their drugs in Russia, which means that the launch of these drugs in the local market will be impossible 19 March 2022
Pharmaceutical
Global drugmakers have no plans to leave Russia, aiming to continue their work in the local market despite the ongoing military escalation in Ukraine and unprecedented sanctions imposed on the country by Western governments, according to recent statements by representatives of companies and some local media, reports The Pharma Letter’s local correspondent. 15 March 2022
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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