ORG
LEO Pharma Acquires Exclusive Global Rights for Boehringer Ingelheim’s Psoriasis Drug Spevigo in €90 Million Deal
LEO Pharma; Boehringer Ingelheim; Spevigo; spesolimab; psoriasis; GPP; drug licensing; immunology; IL-36 receptor; partnership; biotech news
Viome and Scripps Initiate AI-Powered At-Home RNA Test for Early Colon Cancer Risk Detection
Viome; Scripps Research; AI-powered diagnostics; RNA test; at-home colon cancer screening; colon polyps; clinical study; microbiome; early cancer detection
Takeda’s Oveporexton Succeeds in Two Phase III Trials, Paving Way for Narcolepsy Drug Filings
Takeda; Oveporexton; narcolepsy; Phase III trials; orexin agonist; FDA filing; Narcolepsy Type 1; clinical trial results
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