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Pharmaceutical
In January of this year, the US Food and Drug Administration released updated draft guidance for industry entitled “Rare Diseases: Common Issues in Drug Development.” This replaces the previous version issued in 2015.1 7 March 2019
Generics
Even as more blood pressure drugs are being recalled in the USA after being found to contain trace amounts of a potentially cancer-causing ingredient, India’s drug controller is putting stringent quality control measures in place aiming to boost public confidence in generic medicines, reports The Pharma Letter’s India correspondent. 5 March 2019
Pharmaceutical
The growth of the Russian pharmaceutical market has almost come to a halt in recent years, which is mainly as a result of falling incomes of the local population, freezing of state budgets for public procurements and tightened governmental control over the prices for vital drugs in Russia, according to recent statements of some leading Russian drugmakers and officials of the Russian Ministry of Health, reports The Pharma Letter’s local correspondent. 27 February 2019
Generics
As India looks to record its highest ever pharma exports this fiscal year 2018-19, of around $19 billion, there is much apprehension in the air. US President Donald Trump's State of the Union address, which signalled more curbs on drug prices, has left Indian drugmakers an anxious lot, reports The Pharma Letter’s India correspondent. 27 February 2019
Pharmaceutical
China will cut import value-added tax (VAT) from 16% to 3% on the first batch of rare disease drugs from March 1, according to the new policy of China’s National Medical Products Administration (NMPA), formerly known as CFDA, reports The Pharma Letter’s local correspondent, Wang Fangqing. 26 February 2019
Pharmaceutical
Pharmasyntez, one of Russia’s largest drugmakers, has announced its plans to build the largest production facility for hormonal drugs in the country, that will be located in the Tyumen region, according to the company, reports The Pharma Letter’s local correspondent. 19 February 2019
Generics
US drugmaker Abbott says it will expand its Russian production in the Vladimir region this year by the commissioning of two new lines for the production of hospital drugs and the xylene nasal drops, according to an official spokesman of the Vladimir authorities, reports The Pharma Letter’s local correspondent. 19 February 2019
Pharmaceutical
US pharma major Bristol-Myers Squibb is reducing its Russian portfolio of drugs by the suspension of the imports of some of them to the local market, according to the company, reports The Pharma Letter’s local correspondent. 12 February 2019
Pharmaceutical
Drug imports by Russia fell by 7.7% in value terms last year, mainly as a result of the low purchasing power of local consumers and the ever-growing share of generics, according to latest data from the Russian Ministry of Agriculture and some local analysts in the field of pharmaceuticals, reports The Pharma Letter’s local correspondent. 12 February 2019
Pharmaceutical
Shifting focus from generic drugs to specialty drugs amidst continued price erosion in the USA, Indian drug majors have started working towards having enough cancer-fighting drugs in their product pipeline, reflecting a global trend where companies are rushing to tap a market that is estimated to touch $138 billion worldwide this year, reports The Pharma Letter’s India correspondent. 7 February 2019
Pharmaceutical
February 28th is World Rare Disease Day - a day to increase awareness of rare diseases and their impact on those affected. We take this opportunity to provide an overview of five of the rarest diseases in the world and to delve into what pharma must do to progress this therapeutic field further. 5 February 2019
Biotechnology
The Russian Ministry of Health has summed up the results of the first 10 tenders for the supply of drugs against five orphan diseases within the Seven Nosologies state program, a program which involves purchases of the most expensive drugs for state needs, according to press-service of the Ministry, reports The Pharma Letter’s local correspondent. 4 February 2019
Pharmaceutical
Bangkok, Thailand-based Besins Healthcare has officially announced the completion of construction of a new pharmaceutical factory in the Russian Yaroslavl region, according to the company, reports The Pharma Letter’s local correspondent. 4 February 2019
Pharmaceutical
Russia’s leading drugmakers, represented by the National Association of Pharmaceutical and Medical Products Manufacturers (APF), have sent an official petition to the Russian federal government, where they complain about the activities of domestic pharmacy chains, which are lobbying for the interests of their foreign rivals operating in the Russian pharmaceutical market, reports The Pharma Letter’s local correspondent. 28 January 2019
Pharmaceutical
Pharmstandard, one of Russia’s largest drugmakers, has officially launched a new line for the production of drugs against asthma at the facilities of its factory in the Kursk region, according to recent statements of regional authorities. 28 January 2019
Pharmaceutical
Russian and foreign drugmakers operating in the local market, will be obliged to reduce prices of drugs, which have a status of vital and essential in Russia if prices for these drugs have declined in the country of origin or in a number of countries abroad, according to the latest initiative of the Russian government. 21 January 2019
Pharmaceutical
Germany’s Merck KGaA has launched full-cycle production of its Glucophage (metformin), Glucophage Long drugs, designed for the treatment of potential diabetes and type 2 diabetes mellitus in Russia at the facilities of its Russian partner Nanolek in the Kirov region, according to recent statements of both companies. 21 January 2019
Generics
The Indian Union Health Ministry has banned 80 more fixed-dose combination (FDC) drugs which include antibiotics, painkillers, and medicines used for treating hypertension and anxiety, reports The Pharma Letter’s India correspondent. 19 January 2019
Pharmaceutical
Japanese drugmaker Takeda has officially announced that it has invested more than 98 million euros (~$112 million) in the development of drug production in Russia during the 2010-2018 period. 10 January 2019
Pharmaceutical
Since becoming Commissioner of the Food and Drug Administration (FDA) in 2017, Dr Scott Gottlieb has impressed both supporters and critics. 7 January 2019
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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