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
Russia plans to take additional measures to speed registration of new drugs in the domestic market – in a move, that will allow the country to avoid a potential shortage caused by sanctions and their consequences, reports The Pharma Letter’s local correspondent. 27 July 2022
The Russian Associations of cancer patients have called on the European Coalition of Cancer Patients and the Russian Ministry of Health to conduct additional talks with US pharma major Bristol-Myers Squibb, to continue the supplies of some of the company’s anticancer drugs to the Russian market, reports The Pharma Letter’s local correspondent. 18 July 2022
India's Department for Promotion of Industry and Internal Trade (DPIIT) has been instructed by the Kerala High Court to consider compulsory licensing for the breast cancer drug ribociclib, marketed by Swiss pharma giant Novartis under the brand names Kisqali and Kryxana, reports The Pharma Letter’s local correspondent. 14 July 2022
US pharma giant Merck & Co, known as MSD outside of the USA and Canada, has stopped its supplies of vaccines against chickenpox, rubella, measles and mumps to Russia but will continue sales of its drugs that do not have Russian analogues, reports The Pharma Letter’s local correspondent. 9 July 2022
Around one in 10 medical products in circulation in low- and middle-income countries is substandard or counterfeit, according to the World Health Organization (WHO), reports The Pharma Letter’s Latin American correspondent. 4 July 2022
India's drug regulator seems to be taking into account the views of the domestic drug industry, which urged the Central Drugs Standards Control Organization (CDSCO) to consider extending the fast-track approval process adopted during COVID-19 to non-Covid drugs as well. Apart from domestic majors, multinational pharma companies, with their vaccines and drugs, also stand to benefit, reports The Pharma Letter’s India correspondent. 30 June 2022
Russia is reducing procurements of expensive Western original drugs for the treatment of HIV, switching to cheaper medicines, due to the lack of funds and the ever-growing number of patients with HIV in the country, reports The Pharma Letter’s local correspondent. 28 June 2022
Drug repurposing involves the use of existing drugs for new indications.1 Repurposed drugs include not only previously approved drugs but also clinically failed and investigational drugs.2 24 June 2022
As the COVID-19 pandemic has prompted multinational pharma corporations to adopt a ‘China Plus One’ strategy, Indian government officials are urging domestic players to take advantage of the opportunity to become a viable alternative to China. 18 June 2022
Pharma can boast a major role in improving the quality of life of patients with diseases such as breast cancer and rheumatoid arthritis in Latin America, writes The Pharma Letter’s local correspondent. 17 June 2022
More and more global pharmaceutical companies are refusing to test new drugs in Russia. In the first five months, the number of approvals for clinical trials for drugmakers from the European Union and the USA in Russia has decreased by 18.5%, while for Russian manufacturers it grew by almost 90%, mainly due to generics, reports The Pharma Letter’s local correspondent. 15 June 2022
Global drugmakers and their Russian partners are losing their positions in the Russian market for anti-cancer drugs due to expiration of patent protection for a number of their drugs and their replacement by Russian-made generics, reports The Pharma Letter’s local correspondent. 1 June 2022
As Januvia/Janumet (sitagliptin), a Merck & Co drug, nears patent expiry, India's drug price regulator National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of fixed-dose combinations of several anti-diabetic drugs with a 50% reduction on the patented component in a move set to increase the price war in India's $2.3 billion anti-diabetic drugs market. Howls of protest have followed the move, reports The Pharma Letter’s India correspondent. 30 May 2022
Prader-Willi Syndrome (PWS) awareness takes place every year in May, offering a time to reflect on the current and future treatment landscape. 24 May 2022
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
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
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
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
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
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