Incyte’s Minjuvi (Tafasitamab) Combination Gains the EC Approval for R/R Follicular Lymphoma (FL)

Shots: The EC has approved Incyte's Minjuvi + rituximab & lenalidomide for the treatment of adults with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Approval was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL or r/r nodal, splenic or extranodal MZL…

ByRidhi RastogiDecember 18, 2025

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Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

Shots: Kyverna has reported P-II (KYSA-8) trial data assessing a single dose of mivocabtagene autoleucel (miv-cel; KYV-101) in 26 SPS pts having an inadequate response with non-approved treatment options Trial met its 1EP with 46% median improvement in T25FW & 81% pts achieving a clinically meaningful ≥20% gain, plus significant benefits were seen across all…

ByRidhi RastogiDecember 17, 2025

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May Health’s Anavi System Receives the European CE Mark for Women with PCOS-Related Infertility

Shots: May Health has received CE Mark for its Anavi System to treat PCOS-related infertility based on EU & US ULTRA studies in anovulatory or oligo-ovulatory women with PCOS who failed, declined, or were contraindicated to 1L therapy At 12mos. (26 evaluable pts/32), 77% (20/26) ovulated (13 spontaneously & 7 after restarting 1L therapy), with…

ByRidhi RastogiDecember 17, 2025

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Vir Biotechnology Licenses Tobevibart & Elebsiran Combination to Norgine in EU, Australia and New Zealand

Shots: Vir Biotechnology has granted Norgine Pharma, an affiliate of Norgine exclusive commercial rights to the combination of tobevibart & elebsiran for the treatment of chronic hepatitis delta (CHD) in EU, Australia & New Zealand As per the deal, Vir will receive ~$64.5M (€ 55M) as initial reimbursement payment & ~ $581.3M (€ 495M) in…

ByRidhi RastogiDecember 17, 2025

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GeneScience Pharmaceutical Inks ~$1.3B Deal with Yarrow Bioscience for GS-098

Shots: GeneScience has entered into an exclusive global ex-China license agreement with Yarrow, backed by RTW Investments, for GS-098 (YB-101 outside of China) to treat Graves’ disease (GD) & thyroid eye disease (TED) As per the deal, Yarrow will obtain exclusive global ex-China rights to develop, manufacture, & commercialize GS-098 for GD & TED,…

ByRidhi RastogiDecember 17, 2025

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Harbour BioMed and BMS Collaborate in ~$1.1B Deal to Advance Next-Generation Multi-Specific Antibodies

Shots: Harbour BioMed has entered into a multi-year, global strategic collaboration & license agreement with BMS to discover & develop next-generation multi-specific antibodies leveraging the Harbour Mice platform As per the deal, Harbour BioMed & BMS will jointly identify & advance multi-specific antibody programs, with Harbour eligible for $90M in total payments, ~$1.03B in development & commercial…

ByRidhi RastogiDecember 17, 2025

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GSK Reports the FDA Approval of Exdensur (Depemokimab-ulaa) for Asthma with Eosinophilic Phenotype

Shots: FDA has approved GSK’s Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with an eosinophilic phenotype following MHRA’s approval for both asthma & CRSwNP; regulatory review is ongoing in EU, Japan & China Approval was based on the P-III trials: SWIFT-1 (n=382) & SWIFT-2 (n=380) assessing Exdensur vs PBO, both in addition to SoC,…

ByRidhi RastogiDecember 17, 2025

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InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)

Shots: Innocare has reported P-IIb trial data assessing orelabrutinib (50 or 75mg, QD, PO) vs PBO in 187 SLE pts for 48wks. & NMPA approval to initiate P-III trial Trial met its 1EP, with 75mg achieving a significantly higher SRI-4 response at Wk. 48 vs PBO (57.1% vs 34.4%) & showing dose-dependent efficacy over 50mg; 75mg…

ByRidhi RastogiDecember 16, 2025

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AstraZeneca Reports EC Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Shots: The EC has approved AstraZeneca’s Saphnelo (anifrolumab; 120mg, SC, QW, PFS) for the treatment of adults with SLE in combination with SoC; regulatory review is ongoing in the US & Japan Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo vs PBO in 367 pts (18-70yrs.) with mod. to sev. active, autoantibody-positive SLE while receiving SoC,…

ByRidhi RastogiDecember 16, 2025

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Dren Bio and Sanofi Forge ~$1.8B Deal to Advance Next-Generation B-Cell Depletion Therapy

Shots: Dren Bio has partnered with Sanofi to discover & develop next-generation B-cell depleting therapy for the treatment of various autoimmune diseases As per the deal, Dren Bio will receive $100M upfront & ~$1.7B in milestones, with both parties jointly leading discovery & preclinical work using Dren Bio’s platform, after which Sanofi will handle…

ByRidhi RastogiDecember 16, 2025

Ridhi Rastogi

Incyte’s Minjuvi (Tafasitamab) Combination Gains the EC Approval for R/R Follicular Lymphoma (FL)

Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

May Health’s Anavi System Receives the European CE Mark for Women with PCOS-Related Infertility

Vir Biotechnology Licenses Tobevibart & Elebsiran Combination to Norgine in EU, Australia and New Zealand

GeneScience Pharmaceutical Inks ~$1.3B Deal with Yarrow Bioscience for GS-098

Harbour BioMed and BMS Collaborate in ~$1.1B Deal to Advance Next-Generation Multi-Specific Antibodies

GSK Reports the FDA Approval of Exdensur (Depemokimab-ulaa) for Asthma with Eosinophilic Phenotype

InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)

AstraZeneca Reports EC Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Dren Bio and Sanofi Forge ~$1.8B Deal to Advance Next-Generation B-Cell Depletion Therapy

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