Pharma & Biotech News , from our Global Correspondents
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Biosimilars
Russian drugmaker Geropharm plans to become one of the leading players in the domestic insulins market within the next several years, with the possible launch of a biosimilar of ultra-long-acting insulin, produced by the Danish diabetes care giant Novo Nordisk, as well as a further expansion of its portfolio. 2 March 2021
Generics
An objective to attain self-reliance and reduce import dependence in India's pharmaceutical sector has resulted in the India government clearing 19 applications in a rapid-fire way with a committed investment of $628.84 million under its ambitious production linked incentive (PLI) scheme for the promotion of domestic manufacturing of critical key drug intermediates and active pharmaceutical ingredients (APIs), reports The Pharma Letter’s India correspondent. 1 March 2021
Generics
Russia needs a total overhaul of its patent regulation system with regard to pharmaceuticals, with the aim to ensure access for the local population to cheaper drugs, according to recent statements by local pharma analysts and some domestic media, reports The Pharma Letter’s local correspondent. 23 February 2021
Biotechnology
Sunday February 28 is Rare Disease Day – a time to review the current orphan drug landscape and the opportunities and challenges presented to the pharmaceutical industry. 22 February 2021
Biotechnology
Recent years have seen a growing number of Chinese biotechs doing their clinical studies outside China, reports The Pharma Letter’s local correspondent Wang Fangqing. 17 February 2021
Biotechnology
In what is being considered a major fillip to the nation's biotechnology sector, the Indian government has decided to focus on product development commercialization biotech ecosystem in smaller tier-2 and tier-3 towns. A healthy engagement with biotech start-ups is being encouraged across the country, with an aim to take the industry to $150 billion by 2025, reports The Pharma Letter’s India correspondent. 17 February 2021
Generics
The Russian Ministry of Economy has prepared a draft order that will limit the ability of pharmaceutical companies to patent other forms of already known chemical compounds in Russia, according to recent statements by some senior state officials and local media, reports The Pharma Letter’s local correspondent. 17 February 2021
Pharmaceutical
The use of digital health technologies has grown rapidly over the last couple of years – accelerating even more during the COVID-19 pandemic. As digital health continues to hold an important place in modern healthcare, it is critical to ensure the safety of digital health devices and applications. Regulation of these devices by the US Food and Drug Administration (FDA) is fundamental to achieving this goal. 15 February 2021
Pharmaceutical
The Russian government has officially approved a procedure for the purchase of some high-priced drugs for children with orphan diseases, according to recent statements by the press-service of the Russian government. 9 February 2021
Biotechnology
The Russian Ministry of Health has begun centralized procurements of Ocrevus (ocrelizumab) - a drug for the treatment of the most severe form of multiple sclerosis, reports The Pharma Letter’s local correspondent. 8 February 2021
Generics
Russian drugmaker Pharmsynthez has begun production of a remdesivir generic, the drug that was originated by the US biotech Gilead Sciences (Nasdaq: GILD) and marketed under the Veklury brand, reports The Pharma Letter’s local correspondent. 2 February 2021
Biotechnology
The Indian pharmaceutical sector is set to grow three-fold in the next decade, according to the country's Economic Survey. COVID-19 appears to have presented both an opportunity and a challenge for India to emerge as the 'pharmacy of the world', reports The Pharma Letter’s India correspondent. 1 February 2021
Biotechnology
Hypereosinophilic syndrome (HES) refers to a group of rare blood disorders that are characterized by a marked overproduction of eosinophils (white blood cells that lay an important role in immunity). While the exact prevalence of HES is unknown, the World Health Organization reported age-adjusted incidence of about 3-4 people per 10,000,000 between 2001 and 2005. 28 January 2021
Pharmaceutical
French pharma major Sanofi appears to have the opportunity to restore exclusive rights on insulin glargine in Russia as the Russian Intellectual Property Court has overturned a lower court decision to revoke Sanofi's patent for the drug, trade name Lantus, on the basis of a judicial claim submitted for the Russian drugmaker Geropharm a while ago, reports The Pharma Letter’s local correspondent. 26 January 2021
Pharmaceutical
The number of pharmaceutical companies supplying their drugs for state needs as part of the most expensive procurement programs in Russia fell by 30% in 2020, as the level of competition in this market segment is tightened, according to recent statements, by some senior officials of the Russian Ministry of Health and some local media, reports The Pharma Letter’s local correspondent. 26 January 2021
Biotechnology
Chinese biotechs must keep their eyes on markets outside China if they want to survive and thrive, said speakers at the China Biomed conference held online on January 12. 19 January 2021
Pharmaceutical
The anti-cancer therapeutic sector will act as the major driver for growth for the Russian pharmaceutical market in 2021, as the demand for these drugs, particularly during state tenders remains stable, according to recent statements by some leading Russian pharma analysts and producers, reports The Pharma Letter’s local correspondent. 19 January 2021
Biotechnology
Investors will continue to chase after Chinese biotechs despite obvious bubbles, said speakers from several venture capitals and biotechs at China Biomed innovation and investment conference held online on January 12, reports The Pharma Letter’s correspondent Wang Fangqing. 18 January 2021
Generics
Highlighting over-medication as a potential hazard while also flagging the prospect of 'profiteering' by drug companies, India's drug price watchdog the National Pharmaceutical Pricing Authority (NPPA) has expressed concern about the many drug cocktail applications that continue to flood its office as also those that are surreptitiously available in the country, reports The Pharma Letter’s India correspondent. 18 January 2021
Generics
In October 2020, the US Food and Drug Administration issued guidance for industry entitled “Referencing Approved Drug Products in Abbreviated New Drug Application (ANDA) Submissions.” 12 January 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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