Spice Biotechnologies Partners with AbTherx to Discover Antibodies in Immuno-Oncology

Shots: AbTherx has entered into a multi-program antibody discovery partnership with Spice Biotechnologies to identify antibodies against targets selected by Spice Bio, using AbTherx’s Atlas Mouse technologies As per the deal, Spice Bio will obtain rights to develop & commercialize antibodies from the collaboration in exchange for research payments, potential clinical & commercial milestones, plus…

ByRidhi RastogiMay 13, 2025

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QIAGEN to Acquire Genoox for ~$80M

Shots: QIAGEN has entered into a definitive agreement to acquire Genoox, a provider of AI-driven software that allows clinical laboratories to scale & accelerate the analysis of complex genetic tests As per the deal, Genoox will receive $70M in cash & up to $10M in additional milestone payments Acquisition adds Franklin, Genoox’s cloud-based platform, to…

ByRidhi RastogiMay 13, 2025

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Genentech Reports P-III (APHINITY) Trial Data of Perjeta Regimen for Early-Stage Breast Cancer

Shots: Genentech has reported 10yr. P-III (APHINITY) trial data assessing Perjeta + Herceptin & CT vs Herceptin + CT vs PBO as an adj. therapy in 4804 pts with operable HER2+ early-stage breast cancer After 10yrs, trial depicted improved OS, with 91.6% pts alive vs 89.8% on Herceptin + CT & PBO, with sustained invasive…

ByRidhi RastogiMay 13, 2025

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MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Shots: The US FDA has approved IND application of MVX-220 for the treatment of Angelman Syndrome (AS) to initiate P-I/II (ASCEND-AS) trial, with first pts dosing expected in H2’25 The P-I/II trial will evaluate the safety, tolerability, & effectiveness of MVX-220 in both adult & pediatric pts with multiple AS genotypes, incl. rare types like uniparental…

ByRidhi RastogiMay 13, 2025

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UK’s MHRA Approves AstraZeneca’s Trixeo Aerosphere with Near-Zero GWP Propellant for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The UK’s MHRA has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) with HFO-1234ze(E), a next-generation, near-zero global warming potential (GWP) propellant for treating COPD in adults; regulatory review is ongoing in EU, China & other regions Approval was based on a next-generation propellant clinical development program assessing Trixeo + HFO-1234ze(E) vs Trixeo + HFA-134a,…

ByRidhi RastogiMay 13, 2025

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Novo Nordisk Reports P-III (REAL8) Basket Trial Data of Sogroya for Children with Growth Disorders

Shots: The P-III (REAL8) basket trial assessed Sogroya (0.24mg/kg, QW or 0.05 mg/kg, QD) in pre-pubertal children with NS, TS, or ISS; SGA-born children were randomized to Sogroya 0.24mg/kg QW or QD dosing (0.035 or 0.067mg/kg) Trial met its 1EP, showing QW dosing was non-inferior to GH therapy (QD) at Wk. 52, with superior HV…

ByRidhi RastogiMay 12, 2025

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Bayer Submits MAA of Eylea 8mg to Japan’s MHLW for Treating Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Shots: Japan’s MHLW has received MAA for Eylea 8mg (114.3mg/ml for injection) to treat pts with macular edema following RVO (central, branch & hemiretinal) supported by the P-III (QUASAR) trial; regulatory filings are ongoing in other markets In the trial, Eylea 8mg (Q8W after 3 or 5 monthly doses) met its 1EP at 36wks. with…

ByRidhi RastogiMay 12, 2025

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LENZ Therapeutics Collaborates with Lotus Pharmaceutical to Commercialize LNZ100 in the Republic of Korea and Southeast Asia

Shots: LENZ has granted Lotus exclusive development, manufacturing, registration & marketing rights of LNZ100 to treat presbyopia in the Republic of Korea & certain Southeast Asian countries incl. Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia & Singapore As per the deal, LENZ will obtain ~$125M in upfront, regulatory & commercial milestones, along with double-digit net sales-based…

ByRidhi RastogiMay 12, 2025

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AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: AstraZeneca has reported P-III (POTOMAC) trial findings assessing Imfinzi in 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi + BCG induction & maintenance, Imfinzi + BCG induction-only, or SoC BCG therapy Imfinzi + BCG induction & maintenance therapy showed improved disease-free survival (DFS; 1EP) vs SoC BCG, while Imfinzi + BCG induction-only did…

ByRidhi RastogiMay 12, 2025

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Teal Health Reports the US FDA’s Approval of Teal Wand for Cervical Cancer Screening

Shots: The US FDA has approved Teal Wand to screen cervical cancer at-home for women (25-65yrs.); commercially available in California by Jun 2025, with further expansion worldwide Approval was based on SELF-CERV study, which showed Teal Wand detected cervical precancer 96% of the time, with 94% participants preferring at-home screening test if it was as…

ByRidhi RastogiMay 12, 2025

Ridhi Rastogi

Spice Biotechnologies Partners with AbTherx to Discover Antibodies in Immuno-Oncology

QIAGEN to Acquire Genoox for ~$80M

Genentech Reports P-III (APHINITY) Trial Data of Perjeta Regimen for Early-Stage Breast Cancer

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

UK’s MHRA Approves AstraZeneca’s Trixeo Aerosphere with Near-Zero GWP Propellant for Chronic Obstructive Pulmonary Disease (COPD)

Novo Nordisk Reports P-III (REAL8) Basket Trial Data of Sogroya for Children with Growth Disorders

Bayer Submits MAA of Eylea 8mg to Japan’s MHLW for Treating Macular Edema Secondary to Retinal Vein Occlusion (RVO)

LENZ Therapeutics Collaborates with Lotus Pharmaceutical to Commercialize LNZ100 in the Republic of Korea and Southeast Asia

AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Teal Health Reports the US FDA’s Approval of Teal Wand for Cervical Cancer Screening

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