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NewsFosun Pharma Secures HK$1B H-Share Buyback via Gland Stake Sale
Fosun Pharma funds a HK$1B H-share buyback by selling ~6% of Gland Pharma for US$294M, raising questions for Gland's CDMO partners.
Indian Immunologicals Disputes Abhayrab Findings, Submits Records
Rezubio Gains FDA, NMPA IND Clearances for Inhaled RZ-520
Data Integrity, Not Scale, Is India's Real Competitive Advantage - Chakravarthi AVPS on India's Pharma Leadership at GPACTS 2026
FDA Issues Emergency Guidance After Neonatal PN Supply Shutdowns
Latest news
11 storiesNovartis Pelacarsen Fails Phase III Lp(a) Trial
Novartis pelacarsen fails Lp(a)HORIZON Phase III primary endpoint in 8,323 patients, raising ASO manufacturing and Ionis collaboration capacity questions.
AstraZeneca Wins FDA Approval for Camizestrant in Breast Cancer
FDA grants AstraZeneca accelerated approval for camizestrant in ESR1-mutation breast cancer, the first ctDNA resistance-guided oncology approval.
AstraZeneca Wins FDA Accelerated Nod for Camizestrant
FDA grants accelerated approval to AstraZeneca's camizestrant with a CDK4/6 inhibitor for ESR1-mutated HR+/HER2- metastatic breast cancer, tied to Guardant360 CDx companion diagnostic.
FDA Flags ZUBB Supplement for Hidden Sildenafil
FDA confirms hidden sildenafil in ZUBB weight-loss supplement intercepted via international mail, raising incoming-material control concerns for QA teams.
Tarsus Acquires Alkeus, Adds Phase 3 Stargardt Drug
Tarsus Pharmaceuticals closes Alkeus acquisition, adding FDA Breakthrough-designated ALK-001 for Stargardt disease to its Phase 3 pipeline.
Teva Gains Investment-Grade Status from All Three Major Rating Agencies After S&P Upgrade
S&P upgrades Teva to BBB-, completing investment-grade ratings from all three major agencies and signalling durable generics stabilisation.
FDA CBER Consolidates Biologics Regulatory Resource Hub for BLA and Compliance Teams
CBER's consolidated resource hub covers BLA submissions, 21 CFR 600–680 compliance, and postmarketing obligations for biologics manufacturers.
Peptides & Complex Generics Symposium 2026 Returns to Mumbai
PCG 2026 returns to Mumbai, bringing global experts together to advance peptide and complex therapeutic innovation.
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AstraZeneca, HUTCHMED Win Phase III NSCLC Trial
SANOVO Phase III data back Tagrisso-Orpathys as first-line NSCLC therapy in China, triggering label expansion and manufacturing scale-up decisions.
Weave Bio and Takeda Deploy AI Regulatory Platform Across 14 Drug Programs
Weave Bio's AI regulatory platform is live across 14 Takeda drug programs, setting a cross-portfolio benchmark for submission workflow automation.
AbbVie Achieves 60% Progression Risk Reduction for Etentamig in Phase 3 Multiple Myeloma Trial
AbbVie's etentamig cut progression risk by 60% across dual primary endpoints in Phase 3, signaling a likely BLA filing and bispecific scale-up challenge.
Worth your time this week
Cipla Signs Qilu Deal to Launch Pembrolizumab Biosimilar in U.S.
EMA Resolves Visudyne Shortage After Registering New EU Manufacturing Sites for Verteporfin
EMA PRAC Launches Safety Review of Injectable Iron Medicines Over Hypophosphataemia and Bone Risk
