Italy Giorgio Palú, President of the Italian Medicines Agency (AIFA) helps us understand how the agency works, explains the criteria they use to evaluate innovative medicines and tells us about AIFA’s independent research program. AIFA has always favoured innovation and, in this context, has defined specific criteria with the aim of…
Europe Nick Sykes of Pfizer discusses the European Commission’s intention to “future-proof” the EU regulatory system and the suggestions for changes that were discussed througout the DIA Europe 2022 meeting. From the May edition of DIA’s Global Forum magazine. In its Pharmaceutical Strategy, the European Commission intends to “future-proof” the EU…
Egypt Four years after Egypt enacted a new universal health law, the country’s pharmaceutical market has consolidated itself as the fastest growing in the Middle East and Africa, far outpacing Saudi Arabia, South Africa, the UAE and Algeria. With USD 6.3 billion in value, Egyptian pharma is about to double its…
MEA The Middle East and Africa, combined, represent the world’s fifth largest regional pharma market. According to IQVIA’s recent figures, most of the largest markets grew, although slowly due to COVID lockdowns, with Saudi Arabia in the top position. Multinational companies continue to “dominate” the region with Gilead Sciences experiencing huge…
USA When the FDA gave Novartis the historic green light for Kymriah – the first gene therapy approved in the United States – in 2017, the agency declared that it was “ushering in a new approach” to the treatment of cancer and other serious and life-threatening diseases. Today, more than 20…
South Korea Chair & Founder, Regenerative Medicine Acceleration Foundation (RMAF), So Ra Park MD, PhD*, comments on the regenerative medicine ecosystem in Korea, the country’s new legislative approach to the field, and the Korean market’s strong potential for growth in Asia. The first approval of a regenerative medicine product in Korea…
Pharma Legal Handbook All legal aspects surrounding the regulatory reforms in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119. 1. Are there proposals for reform or significant change…
Italy Organon Italy’s Alper Alptekin introduces the newly formed women’s health company, his priorities for the Italian affiliate, and how improvements in women’s health can improve gender equality and give women the ability to be stronger, more vocal, and more independent. While Organon’s portfolio is meeting the needs of women,…
Japan Japanese firm Kirin, part of the Mitsubishi Group and best known for its brewing operations, has pledged to invest JPY 100 billion (USD 870 million) into its healthcare/pharma operations amid a slowdown in the Japanese beer market. Beer Today, Gone Tomorrow Japan’s rapidly ageing population and the effects of…
Europe Having moved early on a promising phase II monoclonal antibody, Almirall is inching closer to entering the Sanofi-dominated European market for eczema after posting, along with Eli Lilly, positive phase III results for Lebrikizumab. The Catalan company says it is on track for a 2023 launch on the continent; Lilly…
Global Exactly five months after concluding that it was the right time to “monetize” its investment in a cross-town rival – providing Roche “full strategic flexibility” in the process – Novartis has announced a major restructuring; this time, too, citing financial motives. The Swiss giant – fifth in the global…
Spain Almirall CEO Gianfranco Nazzi dives into the new strategic focus of the global biopharmaceutical company with HQ in Barcelona as it seeks to serve the European medical dermatology market. The Italian executive reflects on his first few months at the helm, the cumulative experience of Almirall’s management board, the global…
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