Innovation

Private Company Edition: Three out of eight $100m-plus venture capital financings so far in December were raised by China-based biotech firms – $110m for SanegeneBio, $108m for D3 Bio and $100m for OTR – reflecting growing interest in drug candidates from the country.

New document sets out a structured framework to help breakthrough medical devices tackling serious health needs navigate EU regulation with greater clarity, collaboration and predictability.

Despite recent setbacks in the field, big pharma still appears to have faith in the tau approach to Alzheimer's, as evidenced by Sanofi's new $1bn-plus deal with Korean venture ADEL for an early stage candidate.

With two late-stage lupus assets finishing recruitment and a newly acquired nephrology franchise running three concurrent Phase III programs, Biogen is making its most significant commitment yet to immunology beyond its legacy MS business.

In this episode of the In Vivo podcast, Kairos Pharma's chief scientific officer discusses developing therapies to reverse drug resistance in oncology, with ENV-105 showing promising Phase II results in resensitizing hormone-resistant prostate cancer.

A review of South Korea's GIFT fast track initiative for high-need drugs reveals that foreign firms have been the main beneficiaries over the first three years.

Beyond the fierce Lilly and Novo Nordisk competition in the weight-management market, other deep-pocketed firms are advancing their novel candidates and seeking a way in through dealmaking.

Hanmi Pharm Group announces new mid-term strategy including expansion of its obesity focus to aging with goal of more than doubling revenue by 2030 and becoming a true global player.

Digital technology and AI have pushed healthcare delivery to a transformational turning point, but market access, budget constraints and scaling adoption of innovation remain the eternal challenges for healthtech manufacturers.

Cellafa Bioscience, an Astellas-Yaskawa joint venture, uses Maholo robotic automation and AI to standardize cell therapy manufacturing, targeting GMP compliance within two years and global expansion.

In the head-to-head Phase III HARMONY trial in metformin-failed type 2 diabetes, HighTide's HTD1801 yielded a mean 1.12% reduction in HbA1c from baseline at 24 weeks, versus 0.93% for AstraZeneca’s Farxiga.

South Korea has laid out comprehensive drug pricing reforms that aim to enhance patient access to treatment, accelerate innovation and stabilize essential drug supplies, but the industry is concerned it could lead to weaker R&D and manufacturing and increased dependency on high-priced imports.