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NewsInnate Pharma Signs USD 580M Lacutamab Deal with Sobi to Fund CTCL Phase 3 Trial
Innate Pharma secures USD 75M upfront from Sobi to fund CTCL Phase 3 trial TELLOMAK-3, with total deal value reaching USD 580M.
Gland Pharma Secures Global CDMO Deal Targeting $100 Million in Annual Injectable Revenue
Unison Pharmaceuticals Appoints Prasad Mahajan as General Manager for Quality and Manufacturing
Innate Pharma Advances Lacutamab to Phase 3 After Sobi Partnership, Appoints Jensen as CMO
Samsung Bioepis Launches OPUVIZ Pre-Filled Syringe Biosimilar Across European Markets
Latest news
11 storiesBiodeal Pharma Secures Rs. 385 Crore from RMB Capitalworks to Fund Multi-Region Market Entry
Biodeal Pharma raises Rs. 385 crore from RMB Capitalworks to expand across CIS, Latin America, Africa, and Europe.
Glenmark Pharmaceuticals Appoints Manoj Chitnis as Senior Vice President in Manufacturing and Quality
Glenmark appoints 30-year industry veteran Manoj Chitnis as SVP, reinforcing manufacturing and quality leadership amid heightened GMP scrutiny.
Nicox Gains China NDA Filing for NCX 470 Glaucoma Drug via Ocumension Partnership
Nicox and Ocumension file NCX 470 NDA with China's NMPA using the same Phase 3 data package submitted to the U.S. FDA.
AB Science Secures EUR 14.2 Million Private Placement to Advance Masitinib and AB8939 Programs
AB Science closes EUR 14.2M private placement, lifting cash to ~EUR 23M to fund masitinib (ALS) and AB8939 (AML) development through 2027.
Sanofi Appoints Archana Subramanya as Head of R&D India Hub
Sanofi appoints Archana Subramanya, former GSK Global Regulatory Centers head, to lead its R&D India Hub.
Kiora Pharmaceuticals Advances KIO-301 Phase 2 Enrollment Toward Coordinated Global Phase 3 Strategy
Kiora advances KIO-301 into higher-dose Phase 2 cohort, targeting Q3 2027 topline data ahead of potential global Phase 3 planning with Théa and Senju.
Emcure Pharma Reports 23% Revenue Rise to Rs 2,580 Crore in Q1 FY2026
Emcure Pharma posts 23% Q1 revenue growth to Rs 2,580 crore, with PAT rising 36.2% and margins expanding 110 basis points.
FDA CBER OTP Convenes Town Hall on CMC Readiness Standards for Gene Therapy BLA Submissions
FDA CBER's OTP addressed CMC deficiencies in gene therapy BLAs, focusing on comparability protocols and stability data at a June 2024 town hall.
FDA Grants Accelerated Approval to Tudriqev for Anti-PD-1 Refractory Advanced Melanoma
FDA grants accelerated approval to Tudriqev for anti-PD-1 refractory melanoma, raising immediate CMC and potency testing obligations for biologics manufacturers.
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Global Calcium Pvt. Limited Receives FDA Warning Letter Over Falsified Batch Records and Deleted Electronic Files
FDA issued a warning letter to Global Calcium Pvt. Limited after inspectors found falsified batch records and deleted electronic files at its Tamil Nadu API facility.
Global Calcium Secures FDA Warning Letter Closure After Corrective Action Review
FDA closes Warning Letter 320-25-30 for Global Calcium Pvt. Limited, with future inspections set to assess sustainability of corrections.
Worth your time this week
Replimune Gains FDA Accelerated Approval for Tudriqev with Nivolumab in Unresectable Melanoma
Zentalis Pharmaceuticals Secures FDA Alignment on Azenosertib Dose After Type D Meeting for Accelerated Approval
Cognition Therapeutics Achieves FDA Design Clarity for Zervimesine Phase 3 Study in DLB Psychosis
