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
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 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
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
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
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
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
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
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
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
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
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
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
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
The shortage of drugs in Russia is deepening, and is currently being observed in almost 70 regions throughout the country and forcing the local state to consider ways to resume stable supplies to local market, reports The Pharma Letter’s local correspondent. 13 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
Domestic drugs and foreign drugs, the production of which is localized in Russia, will be given a priority when included in the list of vital and essential drugs (VED) and expensive drugs, according to a recent resolution signed by the Russian government, The Pharma Letter’s local correspondent reports. 1 August 2024
Major pharmaceutical multinationals are looking to collaborate with Indian drug firms, leveraging their cost-efficient manufacturing capabilities, robust supply chains, and innovative research potential. 31 July 2024
The Russian government will be ready to significantly increase state procurements of drugs against hepatitis C in case of reduction price for them both by global drugmakers and Russian pharmaceutical companies. 31 July 2024
German pharmaceutical major Bayer has refused compensation of more than 400 million roubles ($4.3 million) from Russian Nativa (renamed Spectrum) for the use of patents on the anticancer drug Nexavar (sorafenib), reports The Pharma Letter’s local correspondent. 9 November 2023
Hungarian drugmaker Gedeon Richter has begun supplying generics of foreign drugs for diabetics to Russia – in a move to take the share of those global drugmakers that have left Russia, reports The Pharma Letter’s local correspondent. 8 November 2023
Indian pharmaceutical companies are demonstrating a growing commitment to advancing cancer treatment through substantial investments in biologics. 31 October 2023
Russian pharmaceutical manufacturers have increased the number of clinical trials that are conducted in the domestic market as part of their efforts of import substitution, The Pharma Letter’s local correspondent reports. 31 October 2023
The Slovenian generics drugmaker KRKA has achieved a rehearing of its case in the Russian Presidium of the Intellectual Rights Court (IPR), which could lead to the revocation of US pharma major AstraZeneca's patent for dapagliflozin - a drug for the treatment of type 2 diabetes, reports The Pharma Letter’s local correspondent. 30 October 2023
In October 2022, the US Food and Drug Administration (FDA) released its “Multiple Endpoints in Clinical Trials” document to provide guidance for drug sponsors and other stakeholders regarding best practices in assessment methodologies for medications. 24 October 2023
The first generic version of the popular drug for controlling glucose levels, Ozempic (semaglutide), which is produced by the Danish diabetes care giant Novo Nordisk, has been registered in Russia by a local drugmaker, the Pharma Letter’s local correspondent reports. 18 October 2023
October marks the annual Rett Syndrome Awareness Month, a time to examine the support and research being afforded to advance pharmacological treatments for this rare condition. 18 October 2023
Despite statements from international pharmaceutical companies about the suspension of new clinical trials in Russia after February 24, 2022 invasion of Ukraine, the Anglo-Swedish drug major AstraZeneca will conduct a study of a new drug for the prevention of COVID-19 in Russia, reports The Pharma Letter’s local correspondent. 18 October 2023
One big challenge for pharma companies doing cross-border businesses in China and the USA is the respective cybersecurity law imposed by the two countries. 12 October 2023
Russia is losing its positions in the global drug export market due to difficulties in settlements with foreign partners, caused by sanctions imposed against the country, The Pharma Letter’s local correspondent reports. 10 October 2023
The situation with the availability of modern, original drugs continues to deteriorate in Russia, which is mainly due to ever-tightening sanctions against the country and its growing isolation in the international arena, reports The Pharma Letter’s local correspondent. 9 October 2023
Caught up in the geopolitical tension between China and the West, western pharma multi-national corporations (MNCs) are increasingly cautious about investing in China. 5 October 2023
As Indian pharma majors take giant strides in biosimilars development, Indian policymakers are under pressure to contemplate a set of regulatory changes aimed at promoting their development. 2 October 2023
India's Department of Pharmaceuticals is seeking innovative technologies to reduce the cost of producing Active Pharmaceutical Ingredients (APIs) that are currently imported. 26 September 2023
China’s tension between the US-led West, its down-sliding economy and the increasingly wayward policy making all added to the factors that made investors seek different ways to grow their businesses in the country, said speakers at ChinaBio partnering forum held on September 20 in Shanghai. 25 September 2023
In September 2022, the US President re-authorized the Generic Drug User Fee Amendments (GDUFA). This new iteration is known as GDUFA III and takes effect from October 2022 to September 2027.1 21 September 2023
The share of foreign pharmaceutical companies in the segment of public procurement in Russia reached 63%, the highest figure in the last six years, according to latest market statistics in Russia and local media, reports the Pharma Letter’s local correspondent. 20 September 2023
Pharmasyntez, one of Russia’s leading drugmakers, is preparing a new project in the domestic market, which involves commercial production of dialysis drugs, reports The Pharma Letter’s local correspondent. 19 September 2023