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Bioheng Therapeutics
NEWS

Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL

Shots: The US FDA approved Bioheng’s IND application for CTD402 to treat pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) CTD402 will be evaluated in a P-Ib/II single-arm, open-label, dose-finding study to optimize dosing and accelerate clinical development CTD402 is a CD7-targeted universal CAR-T (UCAR-T) cell therapy that is genetically…
March 5, 2025

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KYORIN & Novartis
NEWS

KYORIN and Novartis Sign a $832.5M Global License Agreement for KRP-M223

Shots: KYORIN and Novartis entered into a global license agreement for KRP-M223 and its back-up compounds discovered by KYORIN As per the agreement, Novartis gets an exclusive global license to develop, manufacture, and commercialize KRP-M223, where KYORIN retains an option to commercialize and manufacture product for the Japanese market, with Novartis retaining an option to co-promote…
March 4, 2025

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GSK
NEWS

The US FDA Accepts GSK’s Depemokimab Review Application for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The FDA has accepted review application for BLA of depemokimab as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP (PDUFA: Dec 16, 2025), based on P-III (SWIFT & ANCHOR) trials, respectively SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…
March 4, 2025

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Johnson & Johnson
NEWS

Johnson & Johnson’s Darzalex (daratumumab) Receives the CHMP’s Positive Opinion for Multiple Myeloma

Shots: The CHMP has recommended Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat newly diagnosed multiple myeloma pts. Opinion was based on P-III (CEPHEUS) trial, which assessed efficacy & safety in transplant-ineligible or deferred NDMM pts (n=395) not planned for ASCT as initial therapy, in 13 countries across North America, South America and…
March 4, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study Evaluating Enhertu in HER2+ Metastatic Gastric Cancer Patients

Shots: The data from P-III (DESTINY-Gastric04) study showed statistically significant and clinically meaningful improvement in OS vs ramucirumab & paclitaxel in 2L HER2+ (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma pts. The safety profile observed in DESTINY-Gastric04 aligns with Enhertu's established safety record. The company expects to present data…
March 4, 2025

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AbbVie & Gubra
NEWS

AbbVie Enters into a Global License Agreement with Gubra to Develop & Commercialize GUB014295 to Treat Obesity

Shots: AbbVie and Gubra entered into a global license agreement to develop & commercialize GUB014295, a potential long-acting amylin analog for obesity treatment As per the deal, AbbVie will lead GUB014295's global development & commercialization, whereas Gubra will get $350M upfront, up to $1.875B development, commercial, sales milestones, with tiered royalties; transaction closure is…
March 4, 2025

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