Tagged with Opinion

Global First published in the November 2025 issue of DIA’s Global Forum, this article by Victoria Gamermanusa (RWD Insights) tackles one of rare disease research’s toughest dilemmas: how to run credible efficacy trials when patient numbers make traditional statistics unworkable. She charts how AI, Bayesian methods, transfer learning, and synthetic data…

UK First published in the November 2025 edition of DIA’s Global Forum, this piece by Jane Morrin O’Rourke, Naho Yamazaki, Becky Purvis (HRA) and Mandy Budwal-Jagait, Jason Wakelin-Smith and Kingyin Lee (MHRA) dives into one of the UK’s most urgent research challenges: how to make clinical trials genuinely inclusive. The authors…

China This week’s China healthcare highlights from PharmaBoardroom content partner Selesta include Lilly’s US$345M AI-driven BsAb licensing deal with XtalPi, IVACTA’s RMB 100M fundraising for in vivo CAR-T therapies, Vigonvita’s HKD 5.873B IPO with 4,974x oversubscription, and Neurocrine’s US$881M global licensing of TransThera’s NLRP3 inhibitors. Clinical breakthroughs feature HighTide’s positive Phase…

China This week’s China healthcare roundup from PharmaBoardroom content partner Selesta highlights Innovent’s record-breaking US$11.4 billion BsAb and ADC partnership with Takeda, DualityBio’s plans for a STAR Market IPO after positive HER2 ADC Phase III data, Biokin’s US$250 million milestone payment from BMS and HKEX IPO approval, and Haixi Pharma’s 36%…

China This week’s China healthcare roundup from PharmaBoardroom content partner Selesta highlights Kite Pharma’s US$1.64B in vivo CAR-T deal with Pregene, Xuanzhu Biopharma’s HKEX debut with a 172% grey market premium, Hansoh’s US$1.53B CDH17 ADC licensing to Roche, and Leads Biolabs’ US$1B autoimmune drug deal with Dianthus. Biokin secured a record…

UK Originally published in the October 2025 edition of DIA’s Global Forum magazine, this article — authored by Mandy Budwal-Jagait, Kingyin Lee, Maria Urdaneta-Abate, Hedwig Ganguly, Rachel Mead, and Louisa Obillo of the UK Medicines and Healthcare products Regulatory Agency (MHRA), together with Catherine Blewett of the Health Research Authority (HRA)…

India As rare disease regulation moves from the margins to the mainstream of global health policy, India faces both a challenge and an opportunity: how to align with international best practices while designing solutions suited to its vast population and limited resources. This article — authored by experts from Power In…

Global Pharma executives are used to navigating complexity, but few periods have tested their judgement like the present. As Brendan Shaw writes, between Washington’s renewed push for “most favoured nation” (MFN) drug pricing, fresh waves of US tariffs, and a volatile global policy mood, the rules of engagement for global pharma…

Global A century after insulin’s discovery transformed Type 1 diabetes from fatal to manageable, access remains deeply unequal. Writing exclusively for PharmaBoardroom, Access to Medicine Foundation CEO Jayasree Iyer explores why half of those who need insulin worldwide still go without it and how only systemic, long-term collaboration between industry, governments,…

China This week’s China healthcare and pharma roundup from PharmaBoardroom content partner Selesta highlights Sichuan Biokin and Binhui Biopharma’s HKEX IPO filings, Betta Pharma’s third IPO attempt, Sirius Therapeutics–B’s HK$1.8B IPO, and Biocytogen’s STAR Market approval. Clinical updates include Eisai’s Leqembi approval for Alzheimer’s, CMS’s NDA plans for ruxolitinib, and RemeGen’s…

Global First published in ISPOR’s Value & Outcomes Spotlight magazine, Shirley V. Wang, PhD, MSc of Brigham and Women’s Hospital, Harvard Medical School, argues that there is an urgent need for transparency in health economics and outcomes research (HEOR). Wang posits that the growing reliance on real-world evidence (RWE) in healthcare…

China This week’s China healthcare and pharma roundup from PharmaBoardroom content partner Selesta highlights Atom Bioscience’s HKEX IPO, Ark Biosciences’ pipeline funding, Mabwell’s USD 1 billion siRNA deal, HiDiamond Bio’s Pre-Series A, and Enrui Kainuo’s CAR-NK cell therapy financing, alongside updates on IASO Bio’s CAR-T long-term data, Fosun’s breast cancer drug…