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Italy Tiziana Mele, managing director of Lundbeck Italia, explains the impact of COVID on mental health care from the perspective of a company dedicated to brain health, outlines the Italian operation that includes both  commercial and production capacities and shares Lundbeck’s support of independent clinical trials in the country. At Lundbeck,…

Europe Pierre Meulien, Executive Director- Innovative Health Initiative, presents the public-private joint undertaking that boasts a total budget of EUR 2.4 billion and aims to build on the work of the Innovative Medicines Initiative to boost collaboration between the European pharmaceutical and related industries and the European Commission.   The Innovative…

Middle East & Africa Apart from a maturing regulatory environment and the expansion of healthcare coverage across the region, a number of other factors are contributing to the evolution of the MEA pharma market. Results from the second wave of a PhRMA-commisioned IQVIA market access study covering Saudi Arabia (KSA), UAE, Kuwait, Lebanon, Jordan,…

Global Merck has agreed to front USD 150 million for Orna Therapeutics’ new investigational class of engineered circular RNA (oRNA) therapies in a collaboration agreement that will also provide the biotech series B financing. This broad strategic collaboration brings together Merck’s significant expertise … with Orna’s compelling circular RNA technology to…

Egypt The head of the Pharmaceutical Chamber of the Federation of Egyptian Industries, Gamal El-Leithy, shares his view on the positive developments driving the growth of Egypt’s pharma market, including the creation of an independent regulatory body and a procurement agency. In addition, he analyses the country’s response to the COVID-19…

Global Sarah Pope Miksinski, executive director/CMS regulatory affairs, and Gregory Rullo, senior director regulatory affairs, at AstraZeneca discuss the need for common ground among regulators and industry when it comes to patient centricity and for strategic leadership to address differing regulatory control-strategy requirements. In today’s increasingly complex and intricate pharmaceutical landscape,…

Italy Guerbet’s Alessandro Bocci – General Manager Italy & Iberia – describes the nearly 100-year-old company’s firm position in the field of contrast media for radiology and its plans for developing a portfolio in artificial intelligence (AI). In addition, he outlines how the Italy, Spain and Portugal cluster made its way…

Egypt The head of the Egyptian Unified Procurement Authority (UPA), Major General Doctor Bahaa El Din Zeidan, outlines the agency’s view on tenders, emphasizing their vision to secure the highest quality at the best price for Egyptian patients, and analyses the country’s healthcare transformation. In addition, he argues in favour of…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? No. At present, a “biosimilar” is not the same as a generic drug. Previously, some biological marketing authorization licenses were obtained by using the same registration pathway of generic medicines (i.e., without the submission of pre-clinical or…

Middle East & Africa Diginova Health Solutions is a platform that incubates and invests in digital health startups and collaborates with governments and regulators to bring digital solutions to the Middle East and North Africa (MENA) region. Healthcare management veteran, founding partner & CEO, Sarper Tanli, discusses the opportunities and challenges posed by digitilisation…

Pharma Legal Handbook The key facts about biosimilars and biologics in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here.   1. Are biosimilar medicines considered the same as generic medicines in your country? A…

Pharma Legal Handbook The key facts about localization in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. Are there any rules or regulations requiring and/or encouraging localization in your…