Hong Kong In March 2024, the Advanced Therapy Product Good Manufacturing Practice Centre (ATP GMP Centre) at the Chinese University of Hong Kong’s (CUHK) Institute of Biotechnology (HKIB) became the first university-led centre within the special administrative region to receive certification for cell and gene therapy manufacturing and a license as an…

Europe Lora Fleifel, Director of Global Value Access & Pricing Operations Europe for Oncology at Merck, dissects the promise and pitfalls of the new EU Joint Clinical Assessment (JCA). The JCA aims to harmonise clinical evaluations to help reduce the significant disparities in patient access to innovative treatments that still exist…

USA Having terminated dozens of HIV-related research grants, the Trump administration’s assault on the field continues. In a major blow to the decades-long search for a vaccine, the US federal government has pulled the plug on the HIV vaccine programme run by the US National Institute of Health (NIH) –the world’s…

Denmark As Denmark launches its ambitious Life Science Strategy 2030, the Danish Medicines Agency (DKMA), long held as the embodiment of European regulatory excellence, is fine-tuning its priorities. New director Nils Falk Bjerregaard sees the DKMA’s role as a “facilitator of innovation,” supporting early-stage development and leveraging real-world data at home,…

Germany A summary of some of the top stories coming out of Germany’s biopharma industry, including Bayer’s EMA win for its Eylea eye therapy; the oncology deal Merck KGaA has cut with SpringWorks Therapeutics; the bispecific antibody alliance between BMS and BioNTech, and Sartorius’ acquisition of microtissue firm MatTek.   Bayer…

Global Writing in ISPOR’s Value and Outcomes Spotlight magazine, Beth Fand Incollingo looks at why health economics and outcomes research may hold the key to solving some of healthcare’s most entrenched access and affordability issues.   Healthcare can only be widely effective if most patients can access and afford it. Yet,…

Global We are living in uncertain times. The US government’s rapid-fire retreat from development aid and multilateral participation has shaken up the global system but – as Brendan Shaw argues, reflecting on the 2025 World Health Assembly – this has created a major opportunity to reshape the international order for the…

USA Regeneron has agreed to pay USD 256 million to acquire at-home DNA test maker 23andMe after the troubled firm declared bankruptcy. Through the buyout, Regeneron will acquire the data of 23andMe’s customers, obtaining the valuable genetic profiles of millions to potentially develop new and lucrative therapies. With ambiguous legal guidelines…

Denmark Having become Europe’s number one pharma success story thanks largely to its blockbuster weight-loss drug, Wegovy, Novo Nordisk has been hit with stiff competition from Lilly and seen a steep decline in market performance. The Danish drugmaker has moved to oust its longstanding CEO and is looking to regain lost…

UK A roundup of the biggest UK pharma news, including the industry’s uncertain position after the UK-US trade accord; Haleon’s full takeover of its Chinese joint venture; AstraZeneca’s acquisition of Belgian biotech EsoBiotec and its exit from neuroscience; GSK’s liver disease asset deal with Boston Pharmaceuticals, and CellCentric’s US expansion.  …

Global Globally some 1.8 million children and young people (CYP) live with type 1 diabetes (T1D) and in low-and middle-income countries (LMICs) prevalence of the disease is on the rise. In many of these countries, health systems lack the resources to manage this complex chronic disease and the insulin used to…

Saudi Arabia Localising the production of medicines has become a core priority for the Saudi government over the past decade as it attempts to increase national health security, create highly skilled jobs, and grow the non-oil economy. Multinational innovators now have a wide range of incentives (as well as enforcement tactics) to…