Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome

Shots: The US FDA has approved Avtozma IV, a biosimilar to Actemra (tocilizumab), for treating cytokine release syndrome in pts (≥2yrs.), covering all Actemra IV-approved indications in the US; expected to be available in the US by Aug 31, 2025 In Jan 2025, the US FDA approved Avtozma IV to treat rheumatoid arthritis (RA), giant…

ByRidhi RastogiAugust 8, 2025

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Flare Therapeutics Reports First Patient Dosing in P-Ib Trial of FX-909 for Urothelial Cancer

Shots: Flare Therapeutics has dosed its first patient with FX-909 in P-Ib trial for the treatment of locally-advanced or metastatic urothelial cancer The P-Ib trial will assess FX-909 (30 & 50mg; QD) in 40 pts, incl. a biomarker-defined population, building on clinical PoC achieved in P-Ia, with P-Ia data to be presented in 2025. Efficacy…

ByRidhi RastogiAugust 7, 2025

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Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease

Shots: Marea Therapeutics has dosed its first patient with MAR001 in P-IIb (TYDAL-TIMI 78) trial for adults at increased risk of atherosclerotic cardiovascular disease (ASCVD) Trial will evaluate MAR001 (300, 450, 900mg; Q4W) vs PBO in ~216 adults with elevated triglycerides & remnant cholesterol at high ASCVD risk, with the 1EP assessing % change from…

ByRidhi RastogiAugust 7, 2025

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Bracco Imaging Reports the NMPA’s Approval of SonoVue for Assessment of Fallopian Tube Patency

Shots: China’s NMPA has approved SonoVue for use in hysterosalpingo contrast sonography (HyCoSy) to detect tubal issues & uterine problems A meta-analysis of 24 studies in 1358 women with infertility & 2661 fallopian tubes showed superior diagnostic performance of HyCoSy with SonoVue, with pooled sensitivity of 93%, specificity of 90%, & accuracy of 96% vs…

ByRidhi RastogiAugust 7, 2025

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Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted RMAT designation to GLPG5101 for the r/r mantle cell lymphoma (MCL) Designation was supported by P-I/II (ATALANTA-1) trial assessing GLPG5101 [50×106 (DL1), 110×106 (DL2) & 250×106 (DL3)] in r/r B-cell Non-Hodgkin Lymphoma pts, incl. those with MCL Trial demonstrated superior ORR & CR rate as well as favorable safety…

ByRidhi RastogiAugust 6, 2025

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UroGen Pharma Reports P-III (ENVISION) Trial Data on Zusduri to Treat LG-IR-NMIBC

Shots: UroGen Pharma has reported P-III (ENVISION) trial data of Zusduri (mitomycin; QW, intravesical) as a chemoablative therapy for adults (n=240) with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) Trial showed a 24mos. DoR of 72.2% (Kaplan-Meier) in pts with CR at 3mos., with a mFU of 23.7mos. after 3mos. CR; the mDoR was…

ByRidhi RastogiAugust 6, 2025

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SERB Pharmaceuticals to Acquire Y-mAbs Therapeutics for ~$412M

Shots: SERB Pharmaceuticals has entered into a definitive merger agreement to acquire Y-mAbs, incl. its asset Danyelza (naxitamab-gqgk), strengthening its rare oncology portfolio As per the deal, SERB will acquire Y-mAbs for a total equity value of ~$412M, with its shareholders receiving $8.6/share in cash, delisting Y-mAbs from Nasdaq; closing expected in Q4’25 Additionally, Y-mAbs’ pipeline incl.…

ByRidhi RastogiAugust 6, 2025

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Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma

Shots: Ethris has dosed the first pts in a P-IIa trial of ETH47 for asthma symptom reduction after rhinovirus challenge, building on P-I trial data, which showed strong respiratory tract activity, local IFNλ induction, antiviral gene activation, & no systemic exposure The P-IIa trial will evaluate ETH47 vs PBO in ~50 adults with asthma who…

ByRidhi RastogiAugust 5, 2025

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Polpharma Biologics Collaborates with Fresenius Kabi to Commercialize PB016 (Biosimilar, Entyvio)

Shots: Polpharma has entered into a global licensing agreement with Fresenius Kabi to commercialize PB016, a biosimilar version of Takeda’s Entyvio (vedolizumab) for the treatment of mod. to sev. ulcerative colitis & Crohn’s disease As per the deal, Fresenius will obtain global commercialization rights to PB016, excl. Middle East & North Africa, while Polpharma will…

ByRidhi RastogiAugust 5, 2025

NEWS

Alcon to Acquire STAAR Surgical Company for ~$1.5B

Shots: Alcon has entered into a definitive merger agreement to acquire STAAR Surgical Company incl. its asset EVO family of lenses (EVO ICL) As per the deal, Alcon will acquire STAAR for a total equity value of ~$1.5B, with its shareholders receiving $28/share in cash; the deal is expected to close within 6-12mos. EVO ICLs are…

ByRidhi RastogiAugust 5, 2025

Ridhi Rastogi

Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome

Flare Therapeutics Reports First Patient Dosing in P-Ib Trial of FX-909 for Urothelial Cancer

Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease

Bracco Imaging Reports the NMPA’s Approval of SonoVue for Assessment of Fallopian Tube Patency

Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

UroGen Pharma Reports P-III (ENVISION) Trial Data on Zusduri to Treat LG-IR-NMIBC

SERB Pharmaceuticals to Acquire Y-mAbs Therapeutics for ~$412M

Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma

Polpharma Biologics Collaborates with Fresenius Kabi to Commercialize PB016 (Biosimilar, Entyvio)

Alcon to Acquire STAAR Surgical Company for ~$1.5B

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