GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The EC has approved Nucala as an add-on maintenance treatment of adults with uncontrolled COPD characterised by raised blood eosinophils phenotype on a combination of an inhaled corticosteroid, a long-acting beta2-agonist (LABA), & a long-acting muscarinic antagonist Approval was based on the P-III (MATINEE) trial assessing Nucala (100mg, SC, Q4W; n=403) vs PBO (n=401)…

ByRidhi RastogiFebruary 6, 2026

NEWS

Bayer Reports P-III (OCEANIC-STROKE) Trial Data on Asundexian for Secondary Stroke Prevention

Shots: The P-III (OCEANIC-STROKE) trial assessed asundexian (50mg, QD, PO) vs PBO, both in combination with antiplatelet therapy, in pts (n=12,327) for prevention of ischemic stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack Trial showed a 26% reduction in recurrent ischemic stroke without increased ISTH major bleeding across all subgroups, met key…

ByRidhi RastogiFebruary 6, 2026

NEWS

Eisai and Henlius Partner to Commercialize Serplulimab in Japan

Shots: Eisai & Henlius have entered into an exclusive commercialization & co-exclusive development & manufacturing license agreement for serplulimab (Hetronifly in the EU) in Japan As per the deal, Eisai will obtain exclusive rights to commercialize serplulimab in Japan in exchange for $75M upfront, ~$80.01M in regulatory milestones, ~$233.3M in sales milestones, with double-digit royalties…

ByRidhi RastogiFebruary 6, 2026

NEWS

Pfizer Reports P-IIb (VESPER-3) Trial Results on PF’3944 in Weight Management

Shots: Assessing PF’3944 (QW titration to QM) in obese/overweight pts without T2D, the trial randomized pts to Arm 1 (0.4mg QW/ 0.8mg QW/ 3.2mg QM), Arm 2 (0.8mg QW/ 3.2mg QM), Arm 3 (0.4mg QW/ 0.8mg QW/ 1.2mg QW/ 4.8mg QM), Arm 4 (0.6mg QW/ 1.2mg QW/ 4.8mg QM), or Arm 5 (PBO) Trial met…

ByRidhi RastogiFebruary 4, 2026

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Exelixis Reports the US FDA’s NDA Acceptance of Zanzalintinib + Tecentriq for Metastatic Colorectal Cancer (mCRC)

Shots: The US FDA has accepted NDA of zanzalintinib + Tecentriq (atezolizumab) for the treatment of adults with mCRC who have been previously treated with fluoropyrimidine, oxaliplatin & irinotecan-based CT, &, if RAS wild-type, an anti-EGFR therapy (PDUFA: Dec 03, 2026) NDA was based on P-III (STELLAR-303) trial assessing zanzalintinib in combination with atezolizumab (n=451)…

ByRidhi RastogiFebruary 3, 2026

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Daiichi Sankyo and AstraZeneca Report the US FDA Priority Review for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: FDA has accepted sBLA & granted priority review to Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy (PDUFA: Q2’26) sBLA was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in…

ByRidhi RastogiFebruary 3, 2026

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Novo Nordisk Reports P-III (REIMAGINE 2) Trial Data on CagriSema for Type 2 Diabetes

Shots: The P-III trial evaluated CagriSema (SC; QW), a fixed-dose combination of cagrilintide & semaglutide, at two dose levels (2.4mg/2.4mg & 1mg/1mg) vs semaglutide (2.4 & 1mg), cagrilintide (2.4mg) alone, & PBO in 2,728 pts with T2D inadequately controlled with metformin ± an SGLT2 inhibitor At 68wks., CagriSema (2.4/2.4mg) outperformed semaglutide (2.4mg), reducing HbA1c by…

ByRidhi RastogiFebruary 3, 2026

NEWS

Sanofi Reports P-III (LEAP2MONO) Trial Data on Venglustat in Type 3 Gaucher Disease

Shots: Sanofi has reported P-III (LEAP2MONO) trial data assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts (≥12yrs.) with GD3 Trial met its 1EP, improving neurological symptoms measured by modified SARA total score & RBANS at Wk. 52, & achieved 3 of 4 key 2EPs, incl. reductions in spleen & liver…

ByRidhi RastogiFebruary 3, 2026

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The CHMP Recommends Incyte’s Zynyz to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots: The CHMP has recommended Zynyz (retifanlimab) + Pt-based CT as 1L treatment of adults with metastatic or with inoperable locally recurrent SCAC Opinion was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + carboplatin & paclitaxelvs PBO & CT in treatment-naïve SCAC pts P-III trial showed a 37% PFS improvement (mPFS: 9.3 vs 7.4mos.); data…

ByRidhi RastogiFebruary 3, 2026

NEWS

Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

Shots: The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab) Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved…

ByRidhi RastogiFebruary 2, 2026

GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Bayer Reports P-III (OCEANIC-STROKE) Trial Data on Asundexian for Secondary Stroke Prevention

Eisai and Henlius Partner to Commercialize Serplulimab in Japan

Pfizer Reports P-IIb (VESPER-3) Trial Results on PF’3944 in Weight Management

Exelixis Reports the US FDA’s NDA Acceptance of Zanzalintinib + Tecentriq for Metastatic Colorectal Cancer (mCRC)

Daiichi Sankyo and AstraZeneca Report the US FDA Priority Review for Datroway to Treat Metastatic Triple Negative Breast Cancer

Novo Nordisk Reports P-III (REIMAGINE 2) Trial Data on CagriSema for Type 2 Diabetes

Sanofi Reports P-III (LEAP2MONO) Trial Data on Venglustat in Type 3 Gaucher Disease

The CHMP Recommends Incyte’s Zynyz to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

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