News

South Korea's Ministry of Food and Drug Safety awards the first stress relief health claim to Affron Saffron, marking a regulatory milestone for pharmaceutical ingredients in the Asian market.

Prominent European biotech venture firms have formed the European Life Sciences Coalition to address the funding disparity faced by European drug startups compared to US and Chinese counterparts.

Pharmaceutical companies, including 16 with Trump pricing deals, raised list prices on 872 brand-name medications with a median 4% increase in early 2026, highlighting ongoing pricing trends amid policy efforts.[1]

EYE PCR has obtained CE Mark certification for its fixOflex endocapsular device under EU MDR, enabling commercialization across Europe for advanced cataract surgery applications.

HanchorBio announced that the U.S. FDA has granted Orphan Drug Designation to HCB101, a next-generation SIRPα-IgG4 Fc fusion protein, for treating gastric cancer, marking a key regulatory milestone.

Shanghai-based ArkBio gains FDA IND clearance to launch Phase 2 proof-of-concept trial for AK3280, a small-molecule anti-fibrotic therapy with promising China Phase 2 data.

The European Medicines Agency has published a new statement from the Drug Shortages Global Regulatory Working Group, addressing critical supply chain challenges in the pharmaceutical sector.

West Pharmaceutical Services announced robust fourth-quarter and full-year 2025 financial results, driven by double-digit organic growth in high-value proprietary components, and introduced fiscal 2026 guidance projecting 4.6% to 6.5% reported net sales growth.

Hong Kong-based Ascletis Pharma Inc. has selected its novel oral amylin receptor peptide agonist ASC36 for clinical development, planning an IND submission to the U.S. FDA in Q2 2026 for obesity treatment.

Nearly a dozen mature biotech companies have formed the Midsized Biotech Alliance of America (MBAA) to protect their interests as the Trump administration advances drug pricing reforms.