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AstraZeneca’s Baxdrostat Achieves Pivotal Phase 3 Success for Hypertension, Validating $1.3B CinCor Acquisition
AstraZeneca; baxdrostat; CinCor Pharma; hypertension; high blood pressure; phase 3 trial; aldosterone synthase inhibitor; $1.3 billion acquisition; clinical trial win; uncontrolled hypertension; treatment-resistant hypertension
FDA Declines Approval of Ultragenyx’s Sanfilippo Gene Therapy Due to Manufacturing Issues
FDA; Ultragenyx; Sanfilippo syndrome type A; gene therapy; manufacturing issues; UX111; regulatory setback; complete response letter; approval delay
GSK’s ViiV Expands Licensing Deal to Increase Access to Long-Acting Injectable HIV Treatment
GSK; ViiV Healthcare; long-acting HIV treatment; cabotegravir; licensing agreement; Medicines Patent Pool; generic manufacturing; HIV; global health
WHO to Develop Guidelines for Gilead’s Twice-Yearly HIV PrEP Injection (Lenacapavir)
WHO; Gilead; Lenacapavir; twice-yearly injection; PrEP; HIV prevention; guidelines; FDA approval
Recent Trends in Specialized Support to Accelerate Biotech Success (2025)
biotech support; CROs; advanced therapies; funding; risk management; strategic partnerships; operational efficiency
Bayer’s Lynkuet (elinzanetant) Wins First-in-World Approval in UK, Challenging Astellas’ Hot Flash Drug
Bayer; elinzanetant; Lynkuet; menopause; hot flashes; vasomotor symptoms; Astellas; non-hormonal therapy; MHRA approval; UK first approval
FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy
FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter
EU Lifts Restriction on Valneva’s Chikungunya Vaccine for Older Adults, Recommends Caution
Valneva; Chikungunya vaccine; IXCHIQ; European Medicines Agency; older adults; safety concerns; label extension; adverse events
Biotech Layoff Wave Hits Karyopharm, Century, and Pacira in 2025
biotech layoffs; Karyopharm Therapeutics; Century Therapeutics; Pacira; 2025 workforce reductions; biopharma restructuring
Apple Watch AI Model Enhances Health Predictions Using Behavioral Data
Apple Watch; AI model; behavioral data; health prediction; machine learning; Wearable Behavior Model; pregnancy detection; Heart and Movement Study