Fragile X syndrome (FXS) is an X-linked dominant disorder characterized by a broad range of clinical manifestations, including intellectual disability, autism spectrum disorder, language deficits, macroorchidism, seizures, and anxiety. 17 July 2023
As the US market prepares to go through a major upcycle following a seven-year downcycle, with numerous key indicators aligning at the same time, Indian pharmaceutical companies are waiting in the wings, poised to leverage the significant opportunity in the small molecule patented drugs segment, reports The Pharma Letter’s India correspondent. 17 July 2023
Eisai has broken new ground in the development of Alzheimer's treatments, gaining the first approval for decades. In the runup to AAIC 2023, we discuss progress with the deputy chief clinical officer of the firm's American business. 6 July 2023
Pharmsynthez, one of Russia's leading drugmakers, is accelerating its expansion in the domestic market by investing more than 20 billion roubles ($223 million) in the building of one of Russia’s largest complexes for the production of active ingredients and finished dosage forms within the territory of the Vorotynsk Industrial Park in the Kaluga region. 4 July 2023
Developing new drugs is a complex and expensive process with a high failure rate. In fact, only about one out of 250 preclinical compounds make it to FDA approval. With an average cost of $40,000 per patient in a phase three clinical trial, the financial impact of failure is staggering. 4 July 2023
AstraZeneca has called on the Russian Ministry of Health to change the conditions for registering prices for generics in Russia, as the current rules, according to the company, prevent original drugmakers from participating in public procurements, reports The Pharma Letter’s local correspondent. 27 June 2023
A few days after the World Health Organization (WHO) flagged seven India-made syrups during a global investigation into contaminated medicines, India's Health Minister Mansukh Mandaviya has asserted that India follows a zero-tolerance policy on spurious medicines. 23 June 2023
CDKL5 deficiency disorder (CDD), which has an incidence of 1 in 40,000 to 60,000 newborns, is a developmental disorder caused by either the presence of a non-functional cyclin-dependent kinase-like 5 (CDKL5) protein known as serine-threonine kinase (STK9), or its complete absence.1,2 20 June 2023
Russia is preparing for a new wave of drug prices growth this year due to a new bill, designed by the national Parliament aimed at tightening a control for the activities of domestic pharmacies, The Pharma Letter’s local correspondent reports. 20 June 2023
Advanced cellular and tissue-engineered therapies offer ground-breaking opportunities for the treatment of diseases. Recent years have seen an uptick in the development and regulatory approval of revolutionary biological therapies across the globe.1 15 June 2023
As a functional, practical and intelligent way to regulate medical products in today’s globalized world—especially with increasing public health needs, limited resources and demand for faster and better treatments—the use of regulatory decisions from other jurisdictions represents a powerful and effective alternative. 14 June 2023
The Russian government plans to significantly increase public procurement of drugs against diabetes this year despite the existing shortage of funds, reports The Pharma Letter’s local correspondent. 14 June 2023
In mid-2014, the Kingdom of Saudi Arabia (KSA) faced one of the most daunting economic development challenges of its modern history, when crude oil prices collapsed by more than half. 9 June 2023
With evolving patient pathways, advances in technology and surges of new data, traditional commercial models have been disrupted, and the expectations and preferences of healthcare providers (HCPs) have changed. 9 June 2023
Russian pharmaceutical companies will receive additional subsidies from the state for the development of analogues of foreign drugs, as part of the current state plans for the reduction of import dependence in the country’s pharmaceutical sector, The Pharma Letter’s local correspondent reports. 9 June 2023
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