Pharma & Biotech News , from our Global Correspondents
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Pharmaceutical
Change is in the air for the Indian clinical trial market. The rapid approval of COVID-19 vaccinations during the SARS-CoV-2 pandemic illustrated the value of clinical studies that could improve therapeutic regimens, and advance evidence-based medicine. 31 July 2023
Pharmaceutical
Having abandoned direct advertising of their drugs in Russia after the outbreak of hostilities in Ukraine, global drugmakers are now continuing active spending on the promotion of their products through medical organizations, allocating funds for research and industry events, reports The Pharma Letter’s local correspondent. 31 July 2023
Pharmaceutical
A drug shortage is defined by the Federal Food, Drug, and Cosmetic (FD&C) Act as a period of time when the demand or projected demand for a drug in the US exceeds its supply.1 22 July 2023
Generics
Prices for imported active pharmaceutical ingredients (APIs) are rising again in Russia after the decline in 2022. This year the growth is equivalent to by 40%-100% year-on-year due to the devaluation of the rouble and the need to use intermediaries for these procurements, reports The Pharma Letter’s local correspondent. 20 July 2023
Pharmaceutical
Leading Russian patient communities have once again called on the state to increase public procurements of HIV drugs – in a move to prevent the risks of a shortage of antiretroviral (ARV) drugs in the second half of 2023, reports The Pharma Letter’s local correspondent. 19 July 2023
Biotechnology
Fragile X syndrome (FXS) is an X-linked dominant disorder characterized by a broad range of clinical manifestations, including intellectual disability, autism spectrum disorder, language deficits, macroorchidism, seizures, and anxiety. 17 July 2023
Generics
As the US market prepares to go through a major upcycle following a seven-year downcycle, with numerous key indicators aligning at the same time, Indian pharmaceutical companies are waiting in the wings, poised to leverage the significant opportunity in the small molecule patented drugs segment, reports The Pharma Letter’s India correspondent. 17 July 2023
Pharmaceutical
The Russian government is considering introducing a risk-sharing mechanism for public procurement of expensive innovative drugs. 13 July 2023
Generics
Global drugmakers continue to defend the rights for their original drugs in Russia by participating in legal disputes with local generics’ producers, The Pharma Letter’s local correspondent reports. 12 July 2023
Biosimilars
Pharmsynthez, one of Russia's leading drugmakers, is accelerating its expansion in the domestic market by investing more than 20 billion roubles ($223 million) in the building of one of Russia’s largest complexes for the production of active ingredients and finished dosage forms within the territory of the Vorotynsk Industrial Park in the Kaluga region. 4 July 2023
Pharmaceutical
To ensure the effective implementation of India's National Rare Disease Policy-2021, the Delhi High Court has formed a five-member National Rare Diseases Committee to ensure that the policy benefits reach the ultimate patients. 30 June 2023
Generics
AstraZeneca has called on the Russian Ministry of Health to change the conditions for registering prices for generics in Russia, as the current rules, according to the company, prevent original drugmakers from participating in public procurements, reports The Pharma Letter’s local correspondent. 27 June 2023
Pharmaceutical
A few days after the World Health Organization (WHO) flagged seven India-made syrups during a global investigation into contaminated medicines, India's Health Minister Mansukh Mandaviya has asserted that India follows a zero-tolerance policy on spurious medicines. 23 June 2023
Generics
India has made it clear that it will not compromise on intellectual property, regulatory data protection, and patent extension as part of ongoing trade negotiations with the UK and the European Union. 22 June 2023
Generics
The Delhi High Court has sought the Indian government's position regarding a petition that challenges the ban on fixed-dose combination (FDC) drugs, reports The Pharma letter’s local correspondent. 20 June 2023
Pharmaceutical
CDKL5 deficiency disorder (CDD), which has an incidence of 1 in 40,000 to 60,000 newborns, is a developmental disorder caused by either the presence of a non-functional cyclin-dependent kinase-like 5 (CDKL5) protein known as serine-threonine kinase (STK9), or its complete absence.1,2 20 June 2023
Pharmaceutical
Russia is preparing for a new wave of drug prices growth this year due to a new bill, designed by the national Parliament aimed at tightening a control for the activities of domestic pharmacies, The Pharma Letter’s local correspondent reports. 20 June 2023
Biotechnology
Advanced cellular and tissue-engineered therapies offer ground-breaking opportunities for the treatment of diseases. Recent years have seen an uptick in the development and regulatory approval of revolutionary biological therapies across the globe.1 15 June 2023
Pharmaceutical
As a functional, practical and intelligent way to regulate medical products in today’s globalized world—especially with increasing public health needs, limited resources and demand for faster and better treatments—the use of regulatory decisions from other jurisdictions represents a powerful and effective alternative. 14 June 2023
Pharmaceutical
The Russian government plans to significantly increase public procurement of drugs against diabetes this year despite the existing shortage of funds, reports The Pharma Letter’s local correspondent. 14 June 2023
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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