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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…

December 17, 2025

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…

December 17, 2025

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…

December 17, 2025

Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis)

Shots: The CHMP has recommended marketing authorization for Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab) Opinion was supported by analytical similarity data and a global P-III trial (n=600 pts) in neovascular AMD across the US, EU, Russia, and India Under the agreement, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the EU (excluding Germany),…

December 17, 2025

Aptar Reports the US FDA Approval of Cardamyst (Etripamil) for PSVT

Shots: The US FDA has approved Aptar’s Cardamyst (Etripamil), developed by Milestone Pharmaceuticals, for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults Cardamyst (Intranasal) is a Bidose (BDS) Liquid Nasal Spray System Aptar collaborated with Milestone Pharmaceuticals to design a custom polypropylene container closure system with an…

December 17, 2025

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,…

December 17, 2025

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…

December 17, 2025

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,…

December 17, 2025

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…

December 16, 2025

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,…

December 16, 2025

NEWS

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

Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis)

Aptar Reports the US FDA Approval of Cardamyst (Etripamil) for PSVT

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)

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