Luye Pharma Launches Erzofri in the US for Schizophrenia and Schizoaffective Disorder

Shots: Luye Pharma has launched Erzofri extended-release injectable suspension in the US to treat adults with schizophrenia & as monotx. or adjunct therapy for adults with schizoaffective disorder Erzofri was approved by the US FDA based on a multiple-dose, parallel-group study evaluating its PK profile & relative bioavailability at steady state vs reference product, demonstrating…

ByRidhi RastogiApril 7, 2025

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Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

Shots: J&J has reported P-IIIb (APEX) trial data assessing Tremfya vs PBO in biologic-naïve PsA pts with inadequate response to standard therapies for 24wks., followed by a 12wk. safety follow-up; eligible pts could enter a 2yr. extension phase prior to the final safety follow-up Trial met its 1EP of improved ACR20 response, showing reduced signs…

ByRidhi RastogiApril 7, 2025

NEWS

ABL Bio Licenses Grabody-B Brain Delivery Platform to GSK for ~$2.76B (£2.15B)

Shots: ABL Bio has entered into a global licensing agreement with GSK for its Grabody-B BBB shuttle platform to develop therapies targeting various novel pathways using antibodies, siRNA, & ASOs for neurodegenerative diseases As per the deal, GSK will handle preclinical & clinical activities, manufacturing, & marketing of the potential programs in exchange for ~$99.4M,…

ByRidhi RastogiApril 7, 2025

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AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

Shots: The EC has approved perioperative Imfinzi regimen to treat resectable NSCLC adults at high risk of recurrence & no EGFR mutations or ALK rearrangements; MAA under PMDA review Approval was based on P-III (AEGEAN) trial assessing neoadj. Imfinzi (1500mg; Q3W × 4 cycles) + CT followed by adj. Imfinzi alone (Q4W × ~12 cycles)…

ByRidhi RastogiApril 4, 2025

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AVITA Medical Launches Cohealyx for Wound Healing in the US

Shots: AVITA Medical has launched Cohealyx, collagen-based dermal matrix in the US Cohealyx is currently being evaluated in the post-market Cohealyx I trial (enrolment ongoing) to further assess clinical outcomes, wound bed preparation for definitive closure, & patient recovery timelines Cohealyx, developed by AVITA & Regenity Biosciences, is designed to support cellular migration & revascularization, allowing…

ByRidhi RastogiApril 4, 2025

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NetraMark Join Forces with Worldwide Clinical Trials to Redefine Clinical Trial Design Using NetraAI Platform

Shots: NetraMark and Worldwide Clinical Trials have entered into a global agreement to utilize NetraMark’s NetraAI platform to advance clinical trial design As per the deal, NetraAI will initially support P-II neuroscience & oncology trials, plus select P-III studies conducted by Worldwide, with broader access extended to Worldwide’s sponsors across all therapeutic areas & trial…

ByRidhi RastogiApril 4, 2025

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Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: The EC has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy, based on the P-III (DESTINY-Breast06) trial; regulatory review is ongoing in Japan & other regions Trial (N=866) assessed Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=153) pts, showing 38% PFS in CT-naïve…

ByRidhi RastogiApril 4, 2025

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Eli Lilly Enters a ~$1.4B Licensing Agreement with Sangamo Therapeutics for its STAC-BBB Capsid

Shots: Sangamo has granted Eli Lilly global exclusive license of STAC-BBB for one initial CNS target, with an option to add up to 4 more targets upon payment of additional license fees, allowing IV delivery of Lilly’s genomic medicines for CNS diseases As per the deal, Lilly will handle R&D, regulatory activities, manufacturing, & global…

ByRidhi RastogiApril 4, 2025

NEWS

Amgen’s Uplizna Receives the US FDA’s Approval for Immunoglobulin G4-related Disease (IgG4-RD)

Shots: The US FDA has approved Uplizna to treat adults with IgG4-RD; regulatory filings for gMG are underway, with completion expected in H1’25 Approval was based on P-III (MITIGATE) trial assessing Uplizna (n=68) vs PBO (n=67) in IgG4-RD adults, which incl. an optional 3yr. OLE & up to 2yrs. of safety follow-up after Uplinza discontinuation Trial…

ByRidhi RastogiApril 4, 2025

NEWS

BridgeBio Oncology Therapeutics Reports the First Patient Dosing in P-I (KONQUER-101) Trial of BBO-11818 for Advanced Solid Tumors

Shots: BBOT has reported first pts dosing in its P-I (KONQUER-101) trial assessing BBO-11818 for advanced solid tumors, with trial enrolling pts globally In cellular assays, BBO-11818 showed pERK inhibition in selected KRAS G12D & G12V-mutant cell lines at lower concentrations, while reducing viability in KRAS G12D/G12V/G12C mutant cells & exhibiting >500-fold selectivity for KRAS…

ByRidhi RastogiApril 3, 2025

Ridhi Rastogi

Luye Pharma Launches Erzofri in the US for Schizophrenia and Schizoaffective Disorder

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

ABL Bio Licenses Grabody-B Brain Delivery Platform to GSK for ~$2.76B (£2.15B)

AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

AVITA Medical Launches Cohealyx for Wound Healing in the US

NetraMark Join Forces with Worldwide Clinical Trials to Redefine Clinical Trial Design Using NetraAI Platform

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Eli Lilly Enters a ~$1.4B Licensing Agreement with Sangamo Therapeutics for its STAC-BBB Capsid

Amgen’s Uplizna Receives the US FDA’s Approval for Immunoglobulin G4-related Disease (IgG4-RD)

BridgeBio Oncology Therapeutics Reports the First Patient Dosing in P-I (KONQUER-101) Trial of BBO-11818 for Advanced Solid Tumors

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