Pharma & Biotech Insights, Interviews & Features
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Biotechnology
At the AAIC in Amsterdam, we’re speaking with two key figures from Lilly's development program for donanemab, as the company presents new data that could help it to push ahead in the treatment of early Alzheimer's. 17 July 2023
Biotechnology
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
Generics
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
Pharmaceutical
The Russian government is considering introducing a risk-sharing mechanism for public procurement of expensive innovative drugs. 13 July 2023
Biotechnology
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
Biosimilars
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
Pharmaceutical
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
Pharmaceutical
An analysis of recent mergers and acquisitions in the pharma sector. 3 July 2023
Pharmaceutical
An Expert View from Chris Blanchette, Novo Nordisk, Kathy Lang, PRECISIONheor, Ross Maclean, Precision Value & Health. 29 June 2023
Generics
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
A feature on efforts to protect patients from unscrupulous actors in the cell and gene therapy field. 16 June 2023
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
A feature analyzing recent investment activity in cell and gene therapies. 9 June 2023
Pharmaceutical
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
Pharmaceutical
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
Generics
Hospitals are rationing cancer treatments. Pharmacies are scrambling to fill routine antibiotic prescriptions. And across the USA, patients are facing growing delays, substitutions, or outright denials of essential medicines, not because the drugs don’t exist, but because the supply chains behind them have buckled. 24 July 2025
Biotechnology
The race to develop effective cancer vaccines has entered a new phase, with late-stage trials from companies like Moderna and BioNTech generating momentum and sharpening investor focus. 23 July 2025
Pharmaceutical
Russian nano giant Rusnano is cutting its pharmaceutical business by beginning a search for buyers for its major pharmaceutical asset – the local drugmaker Novamedica, The Pharma Letter’s local correspondent reports 23 July 2025
Generics
Swiss pharma Sandoz has spent less than a year charting its course as an independent company, but already it’s moving with the confidence of a seasoned player. Since separating from former parent Novartis in October 2023, the generics and biosimilars specialist has been working fast to reshape its identity—and its balance sheet. 22 July 2025
Pharmaceutical
Once seen as a niche tool for rare tumors, theranostics is quickly becoming a new standard in cancer care. Combining diagnostics and therapy in a single platform, the field has drawn billions in pharma investment and sparked regulatory momentum, as precision imaging begins to guide not only what patients receive—but when, how often, and with what expected impact. 18 July 2025
Pharmaceutical
Artificial intelligence has edged past the pilot phase in clinical development. Once a niche add-on, AI is now helping biopharma companies design, recruit, and run trials faster, cheaper, and—crucially—more inclusively. And regulators are starting to pay serious attention. 17 July 2025
Biotechnology
Eli Lilly’s latest acquisition has electrified the biotech world—and sent a clear message that gene editing is no longer just for rare diseases. The US pharma major is paying $1 billion upfront, with a further $300 million in milestones, to buy Verve Therapeutics, a move that positions it squarely in the race to develop one-and-done therapies for heart disease. 16 July 2025
Generics
The number of patent disputes in the Russian pharmaceutical industry has almost doubled in the last several years, while these figures continue to grow these days, The Pharma Letter’s local correspondent reports. 16 July 2025
Pharmaceutical
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. 15 July 2025
Biotechnology
A quiet shift with potentially big implications for cancer drug access is underway in the UK. In June, the country’s health technology assessor, NICE, recommended GSK’s Blenrep (belantamab mafodotin) in multiple myeloma. 14 July 2025
Generics
Even as the US Food and Drug Administration (FDA) has unveiled a strategic expansion of its oversight mechanisms for foreign manufacturing facilities supplying the American market, aiming to bolster product safety and ensure consistent quality for US consumers, the intensified oversight presents significant long-term benefits for the Indian pharmaceutical sector as a whole, reports The Pharma Letter’s India correspondent. 14 July 2025
Pharmaceutical
Data presented on the EURneffy/neffy adrenaline (epinephrine) nasal spray at the European Academy of Allergy & Clinical Immunology Congress last month highlights a comparable clinical pharmacological response to intramuscular adrenaline injection, despite congestion associated with allergic rhinitis. 12 July 2025
Pharmaceutical
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. 11 July 2025
Biotechnology
An Expert View from Justin Kozak, life sciences industry lead, Founder Shield. 4 July 2025
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Generics
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
Pharmaceutical
Last month, the Future Health Report was presented at the World Health Assembly in Geneva, Switzerland. 10 June 2025
Pharmaceutical
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
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