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
GLP1 receptor agonists (GLP1RA) are known as diabetes treatments, but recently they have also doubled as the new generation drugs for overweight/obesity. 5 June 2023
As the crowds descend on Chicago for the annual meeting of the American Society of Clinical Oncology (ASCO), The Pharma Letter interviews Eisai chief medical officer Kirk Shepard about his firm’s progress in oncology. 1 June 2023
This year’s meeting of the American Society of Clinical Oncology (ASCO) kicks off on Friday, with the highly anticipated plenary session taking place on Sunday. 31 May 2023
Even as Tariq Ahmad, UK Minister of State for Foreign, Commonwealth and Development Affairs and India's External Affairs Minister S Jaishankar held talks in Delhi on Monday, and discussed the India-UK Free Trade Agreement (FTA), Indian pharmaceutical companies have joined forces to urge the government to maintain a strong stance on the Patents Act as it negotiates FTAs with key global partners. 30 May 2023
In an effort to decrease pharmaceutical companies profiteering, India's National Pharmaceutical Pricing Authority (NPPA) has said the ceiling price of off-patent pharmaceuticals will be slashed by 50%. 26 May 2023
Ichthyosis is a heterogenous group of disorders characterized by dry, itchy skin that appears scaly and rough like fish scales.1,2 The first case of ichthyosis was described 24 May 2023
Leading Russian drugmakers have called on the state to simplify the launch of their generics to the domestic market by reducing the number of so-called evergreen patents of global majors, reports The Pharma Letter’s local correspondent. 22 May 2023
German pharma major Bayer has filed a lawsuit against the Russian manufacturer of generic drugs Medisorb, The Pharma Letter’s local correspondent reports. 19 May 2023
In the high-stakes world of drug development, a pill is never just a pill. Every oral drug that reaches the market has passed through a tightly managed series of steps—none more critical, or more vulnerable, than tech transfer. 4 July 2025
Artificial Intelligence (AI) is reshaping pharmacovigilance, promising faster detection of safety signals hidden within mountains of adverse event (AE) data. However, as the US Food and Drug Administration (FDA) sharpens its focus on transparency, credibility, and real-world monitoring, the days of relying on opaque algorithms are numbered. In this article, we explore why sponsors and safety teams must rethink their approach to AE prediction to ensure the very tools designed to protect patients don’t become risks themselves. 2 July 2025
Systemic sclerosis is an autoimmune connective tissue disease that causes debilitating fibrosis of the skin and internal organs. It impacts nearly 50,000 people in the USA alone1 and between 7.2 and 33.9 per 100,000 individuals across Europe.2 1 July 2025
In a sector where regulation is tight and reputation is paramount, bold, purposeful leadership has never been more necessary, writes Alessandro Buccella of Heidrick & Struggles, in an Expert View. 26 June 2025
Armed with an asset that could be an improvement on Pfizer’s blockbuster smoking cessation drug Chantix/Champix (varenicline), Achieve Life Sciences (Nasdaq: ACHV) has confidence in its prospects of addressing the global smoking health and nicotine addiction epidemic. 23 June 2025
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
In Latin America, the average percentage of the public budget for health is 12.75%, half of what is allocated by the 38 countries that make up the Organization for Economic Cooperation and Development (OECD), which on average is 24.5%. 9 June 2025
Artificial Intelligence (AI) has rapidly evolved from a promising technology to a core enabler of innovation in the pharmaceutical industry. Today, AI is estimated to generate between $350 billion and $410 billion in annual value for pharmaceutical companies. 29 May 2025
Russian drugmaker Geropharm has received a compulsory license from the Russian state to produce a generic of Ozempic (semaglutide) developed by Denmark’s Novo Nordisk. As in case of Ozempic, Geropharm’s generics are used to treat diabetes, as well as for weight loss, reports The Pharma Letter’s local correspondent. 28 May 2025
Lupus is a rare autoimmune disease characterized by chronic inflammation. It presents in four main forms: systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), drug-induced lupus, and neonatal lupus. 28 May 2025
This week, Dr Kimberly Smith, Senior Vice President, Chief Scientific Officer, Head of Research & Development at ViiV Healthcare, provides an Expert View on how, through a deep understanding of the HIV community, the company has led the way in changing the HIV treatment and prevention paradigm. 23 May 2025
The share of generics in the Russian pharmaceutical market is steadily growing despite the efforts of the local state to create conditions for the production of original drugs, The Pharma Letter’s local correspondent reports. 22 May 2025
Marking International Clinical Trials Day, we bring you a special Q&A with Andrea Manfrin, Deputy Director of Clinical Trials from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). 20 May 2025
Adopting a platform approach to designing new therapies will speed the delivery of innovative genomic treatments to patients—but only if developers, regulators, and manufacturers work together to evolve the current drug development paradigm, writes Vanessa Almendro, vice president of science and technology and head of innovation at Danaher Corporation, in an Expert View piece. 19 May 2025
Representatives of Russian patent unions have sent an appeal to the Russian Scientific Center for Expertise of Medical Products to provide a protocol for the compliance of Lantesens, a drug for the treatment for spinal muscular atrophy (SMA), which is produced by the Russian drugmaker Generium, a copy of the original drug Spinraza (nusinersen) from US biotech Biogen, reports The Pharma Letter’s local correspondent. 14 May 2025
As the US government, under President Donald Trump, is on the verge of announcing significant new tariffs on pharmaceutical imports, Indian drug-maker stocks continue to take a hammering on the bourses. 8 May 2025
MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases.
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