In December 2023, the US Food and Drug Administration (FDA) released a 25-page draft guidance on Potency Assurance for Cellular and Genetic Therapy Products.1 1 March 2024
Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View. 29 February 2024
Indian drugmakers plan to accelerate their expansion in the Russian pharmaceutical market this year, which will be achieved by the building of several large-scale manufacturing facilities within the territory of the country, reports The Pharma Letter’s local correspondent. 29 February 2024
The tides are shifting. As multinational entities such as Novartis, AstraZeneca and Sanofi recalibrate their strategies in India, spurred by intensified local competition and patent expiries, domestic pharma players like Cipla, Torrent Pharma, Eris Lifesciences, and JB Chemicals are asserting their prominence. 29 February 2024
When James Burt, the chief executive of lifecycle management healthcare company Pharmanovia, looks back at the mood in the pharma industry in 2023, he is happy to say that he is already experiencing a greater sense of optimism in 2024. 27 February 2024
In 2023, more than 50% (28 of 55) of the novel drugs reviewed by the US Food and Drug Administration (FDA) received orphan drug designation for the prevention, diagnosis, or treatment of a rare disease.1 20 February 2024
Leading Russian patient associations have called on the state to expand the list of vital drugs and increase their procurements this year, reports The Pharma Letter’s local correspondent. 16 February 2024
India has achieved a notable milestone in the field of cancer treatment with its indigenously developed CAR-T cell therapy, resulting in the first patient being declared cancer-free post treatment. 15 February 2024
Danish drugmaker Lundbeck has its eye on steady growth over the medium term, a strategy which new chief executive Charl van Zyl believes could be key to the firm’s future success. 12 February 2024
Germany-based Vivoryon Therapeutics could well be on the path towards altering the course of Alzheimer’s disease (AD), with a PhII data readout coming up and an option offering potential advantages over recently-approved monoclonal antibodies (mAbs). 9 February 2024
In an Expert View piece, Mark Seymour, Director and Head of Media, Healthcare, at FleishmanHillard London, argues that in the ever-evolving world of healthcare, the rules of communications have not changed, they have just become more intricate, demanding a renewed focus on the essentials. 8 February 2024
The Russian drugmaker Axelpharm is demanding a compulsory license for an antitumor drug based on Bosulif (bosutinib), marketed by US pharma giant Pfizer, reports The Pharma Letter’s local correspondent. 6 February 2024
An Expert View from Ross Maclean, Precision Health Economics, Outcomes Research and Head of Medical Affairs,
Precision Value and Health, and the same company's Jon Bambalas, Senior Vice President Business Development, Products Senior Vice President Business Development. 5 February 2024
Medullary thyroid carcinoma (MTC) is a rare neuroendocrine condition that develops in the parafollicular C cells of the thyroid gland.1 It makes up 3%-5% of all thyroid cancers, with a 10-year mortality rate of about 50%.2 20 January 2024
While 2023 saw the approval of many notable new drugs by the US Food and Drug Administration (FDA), the past year also featured many holds being imposed on clinical trials. 18 January 2024
Russia plans to revise the main concepts of public procurements of anti-tuberculosis drugs in a move to switch on the purchases of more efficient drugs with lower cost and side effects, The Pharma Letter’s local correspondent reports. 15 January 2024
The Indian diabetes battleground is experiencing a fresh wave of firepower, with both domestic and multinational pharma giants unleashing a barrage of new anti-diabetic drugs, The Pharma Letter's local correspondent reports. 15 January 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
The upcoming European Society for Medical Oncology (ESMO) Congress 2024 should provide a reminder—if it were needed—of the pace of innovation in the development of new medicines for cancer. 10 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
Amid an explosion in investment and development milestones seen over the past decade, the age of radiopharmaceuticals as both diagnostics and as therapeutics is very much arriving. 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
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
Accord Healthcare might not be as well-known as certain preeminent pharma corporations in the UK and Europe, but you would struggle to find any company making a greater contribution to the production and supply of medicines across the continent. 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
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
CytoReason’s $80 million venture round may not have been the biggest in July, but it is one of a growing number of investor bets on AI powered drug discovery this year. 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