Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Shots: Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab) Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults Yesintek was previously approved as…

ByRidhi Rastogi1 hour ago

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J&J Partners with Sail Biomedicines to Advance In Vivo CAR-T Therapies

Shots: J&J has entered strategic agreements & collaboration with Sail to advance its lead immune-mediated disease program & in vivo CAR-T platform, with the potential to expand the platform across additional therapeutic targets As per the deal, Sail will receive initial payments of $785M, incl. a $465M equity investment, with additional contingent payments of ~$140M…

ByRidhi Rastogi2 hours ago

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AbCellera and Vertex Pharmaceuticals Team Up on T-Cell Engagers

Shots: AbCellera has entered into a collaboration with Vertex to research, develop, manufacture, & commercialize multispecific T-cell engagers (TCEs) for autoimmune diseases & other conditions As per the deal, AbCellera will use its TCE platform for discovery & early development, while Vertex will fund all R&D costs and retain rights to develop & commercialize resulting…

ByRidhi Rastogi20 hours ago

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Incyte Reports EC Approval of Opzelura (Ruxolitinib) Cream for Moderate Atopic Dermatitis

Shots: The EC has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis in adults for whom topical corticosteroids (TCSs) & topical calcineurin inhibitors (TCIs) are inadequate or inappropriate Approval was based on the P-IIIb (TRuE-AD4) study assessing Opzelura vs vehicle in 241 adults with moderate AD, which met its co-1EPs of EASI75…

ByRidhi Rastogi21 hours ago

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AbbVie Secures EC Approval for Rinvoq to Treat Non-Segmental Vitiligo

Shots: The EC has approved Rinvoq (upadacitinib; 15mg, QD) for the treatment of pts (≥12yrs.) with non-segmental vitiligo (NSV) who are candidates for systemic therapy Approval was backed by the Viti-Up clinical program (M19-044; n=614), incl. 2 replicate trials assessing Rinvoq, where in Period A, pts were randomized to either Rinvoq or PBO for 48wks. &…

ByRidhi Rastogi22 hours ago

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Corbus Pharmaceuticals Reports FDA Clearance to Initiate TEMPO-1 Trial of CRB-701 in OPSCC

Shots: The US FDA has granted clearance to initiate a registrational study (TEMPO-1) of CRB-701, a Nectin-4-targeted ADC, in 2L oropharyngeal squamous cell carcinoma (OPSCC), with enrolment beginning in Sep 2026 Trial (n=250) will evaluate the efficacy & safety of CRB-701 vs investigator’s choice of capecitabine, cetuximab or docetaxel, assessing ORR as the 1EP to…

ByRidhi Rastogi1 day ago

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Elevation Spine Receives US FDA Clearance for Saber-C AVIA

Shots: The US FDA has granted 510(k) clearance to Saber-C AVIA, a zero-profile ACDF system featuring a porous 3D-printed titanium interbody with spike & screw fixation options Saber-C AVIA is designed to deliver the biomechanical stability of traditional plating in a lower-profile implant, featuring updated spike delivery tools, low-profile screw instruments, and a single-tray system…

ByRidhi Rastogi1 day ago

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CORE Biomedicine Licenses Preclinical Oncology Portfolio from Eisai

Shots: CORE Biomedicine has entered into a licensing agreement with Eisai, securing exclusive global rights to develop & commercialize multiple preclinical oncology programs As per the deal, CORE will obtain exclusive, global rights to certain preclinical oncology programs spanning distinct targets & biological pathways, providing CORE with a broad pipeline to develop next-generation precision medicines…

ByRidhi Rastogi1 day ago

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Dyne Therapeutics Reports IND Clearance to Initiate P-I Trial of DYNE-302 for FSHD

Shots: The US FDA has granted IND clearance to initiate a P-I multiple ascending dose trial assessing DYNE-302 against PBO in ambulatory adults with facioscapulohumeral muscular dystrophy (FSHD) In the first cohort, 9 pts will receive DYNE-302 (1.5 mg/kg, Q4W) or PBO, with higher doses & less frequent dosing planned. Pts completing the PBO-controlled phase…

ByRidhi Rastogi2 days ago

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Hansoh Pharma Reports P-III (ARTEMIS-011) Trial Data on Ris-Rez for Osteosarcoma

Shots: Hansoh has reported P-III (ARTEMIS-011) trial data assessing risvutatug rezetecan (HS-20093), a B7-H3–directed ADC, vs CT in pts with osteosarcoma who had progressed or relapsed after receiving ≥2 prior lines of systemic therapy Trial met its 1EP of improved PFS as assessed by the IRC, with consistent benefits observed across 2EPs, incl. OS & investigator-assessed…

ByRidhi Rastogi2 days ago

Ridhi Rastogi

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

J&J Partners with Sail Biomedicines to Advance In Vivo CAR-T Therapies

AbCellera and Vertex Pharmaceuticals Team Up on T-Cell Engagers

Incyte Reports EC Approval of Opzelura (Ruxolitinib) Cream for Moderate Atopic Dermatitis

AbbVie Secures EC Approval for Rinvoq to Treat Non-Segmental Vitiligo

Corbus Pharmaceuticals Reports FDA Clearance to Initiate TEMPO-1 Trial of CRB-701 in OPSCC

Elevation Spine Receives US FDA Clearance for Saber-C AVIA

CORE Biomedicine Licenses Preclinical Oncology Portfolio from Eisai

Dyne Therapeutics Reports IND Clearance to Initiate P-I Trial of DYNE-302 for FSHD

Hansoh Pharma Reports P-III (ARTEMIS-011) Trial Data on Ris-Rez for Osteosarcoma

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