APAC’s rising stars beyond China
While China continues to dominate clinical trial activity across Asia-Pacific (APAC) and globally, other countries are rapidly emerging as significant …
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UK MHRA clears Ensoma’s EN-374 trial application for X-CGD
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has cleared Ensoma’s clinical trial authorisation (CTA) application for its in …
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EpilepsyGTx secures $33m to progress FRE therapy through Phase I/IIa trials
Biotechnology firm EpilepsyGTx has secured $33m in a Series A funding round to progress its adeno-associated viral (AAV) gene therapy, …
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BioNTech and BMS’ bispecific touts 59.3% nine-month PFS in TNBC
Bristol Myers Squibb (BMS) and BioNTech's pumitamig has displayed promising efficacy and safety during a mid-stage trial in front and …
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Roche posts second Phase III win for oral SERD
Roche’s oral selective oestrogen receptor degrader (SERD) has reduced the risk of invasive disease recurrence or death by 30% in …
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Roche posts second Phase III win for oral SERD
Roche’s oral selective oestrogen receptor degrader (SERD) has reduced the risk of invasive disease recurrence or death by 30% in …
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ASH 2025: AbbVie and Genmab’s Epkinly sets new standard in second-line FL
At the American Society of Hematology (ASH) Annual Meeting, held on 6-9 December, results from the global, multicentre, open-label, randomised, …
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ASH 2025: Eli Lilly’s Jaypirca emerges as a strong first-line contender in CLL/SLL
At the American Society of Hematology (ASH) Annual Meeting, held on 6-9 December updated results from the global, multi-centre, open-label, …
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Brazilian study links postnatal rapid weight gain to elevated paediatric BMI
Rapid weight gain in early life is a well-documented risk factor for childhood obesity, as well as the onset of …
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New HBV vaccine guidance likely to increase infection among newborns
The US Advisory Committee on Immunization Practices (ACIP) has voted to recommend delaying the hepatitis B virus (HBV) vaccination administered …
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Novartis reports positive data from VAYHIT2 trial for immune thrombocytopenia
Novartis has reported positive outcomes from the VAYHIT2 Phase III trial assessing ianalumab plus eltrombopag to treat patients with primary immune …
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ASH 2025: potential new BCL2 inhibitor option for R/R CLL
At the 2025 American Society of Hematology (ASH) Congress, held on 5-9 December, results from a Phase II pivotal study …
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Daiichi Sankyo announces first patient dosed in Phase III trial of Enhertu
Daiichi Sankyo has announced the dosing of first patient in the DESTINY-Ovarian01 Phase III trial’s randomisation phase, assessing Enhertu (trastuzumab …
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Dyne to seek accelerated approval of DMD drug on Phase I/II data
Dyne Therapeutics is seeking US accelerated approval of its Duchenne muscular dystrophy (DMD) drug after it met its endpoints in …
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Utilising real-world data to overcome challenges in rare disease research
Innovative approaches like synthetic control arms based on real-world data may help overcome the unique challenges faced in clinical trials …
