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Pharmaceutical
A drug shortage is defined by the Federal Food, Drug, and Cosmetic (FD&C) Act as a period of time when the demand or projected demand for a drug in the US exceeds its supply.1 22 July 2023
Biotechnology
Following the successful development and rapid roll-out of its COVID-19 vaccine, Moderna has wasted no time in seeking to prove that it is not a one-trick pony. 21 July 2023
Biotechnology
Over the last few days, attendees of the ongoing annual meeting of the Alzheimer’s Association have been arriving in Amsterdam for what has turned out to be a particularly exciting congress. 18 July 2023
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
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
Generics
The Russian pharmaceutical market, valued at around $41 billion, continues to be a magnet for Indian pharmaceutical companies. 9 June 2025
Pharmaceutical
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
Generics
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
Biotechnology
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
Pharmaceutical
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
Generics
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
Pharmaceutical
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
Biotechnology
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
Generics
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
Pharmaceutical
A Feature on M&A, VC investment, licensing and partnerships in the radiopharmaceuticals arena. 9 May 2025
Pharmaceutical
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
Pharmaceutical
The Russian government will consider registering next-in-class drugs based on data from the second phase of clinical trials (CT) as well as will implement other measures in order to avoid a shortage of drugs in domestic market this year, The Pharma Letter’s local correspondent reports. 7 May 2025
Pharmaceutical
The pharmaceutical industry in Latin America is currently facing several challenges in terms of containment of chronic non-communicable diseases, impacted by the lack of adherence to treatments and the delay in access to innovations in diagnosis, treatment, control and follow-up. 2 May 2025
Pharmaceutical
April marks Sarcoidosis Awareness Month - a timely opportunity to highlight recent advances in the treatment of this rare condition. 2 May 2025
Pharmaceutical
Shortly after Robert F Kennedy Jr was sworn in as Secretary of Health and Human Services (HHS), US President Donald Trump issued an executive order establishing the Make America Healthy Again Commission. 1 May 2025
Pharmaceutical
The Russian drugmaker Akrikhin has filed a lawsuit against UK pharma major AstraZeneca to the Moscow Intellectual Property Court asking to recognize its right to use formulas from two patents of Astra Zeneca for production of Forxiga (dapagliflozin), a drug for the treatment of diabetes and cardiovascular diseases, The Pharma Letter’s local correspondent reports. 1 May 2025
Pharmaceutical
The Russian pharmaceutical market grew up to 814 billion roubles ($10 billion) in the first quarter of 2025, 11% higher compared to the same period in 2024, according to latest data, provided by experts of the Russian research agency in the field of pharmaceutics DSM-Group and some local media reports, reports The Pharma Letter’s local correspondent. 30 April 2025
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