NEWS

Ethris Secures €30M Financing to Advance Respiratory mRNA Programs

Shots: Ethris, the European Investment Bank (EIB) & European Commission’s Health Emergency Preparedness and Response Authority (DG HERA) have signed a €30M financing agreement to advance Ethris’ respiratory mRNA portfolio The portfolio incl. ETH47 for asthma & COPD, and ETH52 & ETH53 for mucosal influenza vaccines & pandemic preparedness. The financing will support advancing ETH47…

September 10, 2026

Genentech Secures the US FDA Priority Review for Enspryng (Satralizumab) to Treat MOGAD

Shots: FDA has granted Priority Review to the sBLA of Enspryng for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), with a PDUFA target action date set for Jan 10, 2027. Filing is also under EMA’s review, with a decision expected in Q3’27 sBLA was supported by the P-III (METEOROID) trial data, assessing Enspryng(60,…

September 10, 2026

Japan’s MHLW Approves GSK’s Shingrix PFS Presentation to Protect Individuals Against Shingles

Shots: Japan’s MHLW has approved Shingrix in a PFS format (Recombinant Zoster Vaccine or RSV) for the prevention of shingles (herpes zoster) Approval was based on technical comparability between the PFS & existing vaccine presentation; the new presentation does not involve a change in indication or dosing Shingrix combines glycoprotein E with the AS01B…

September 10, 2026

Emboline Receives US FDA 510(k) Clearance for Emboliner Embolic Protection System

Shots: FDA has granted 510(k) clearance to Emboliner Embolic Protection System for use as an embolic protection device to capture & remove embolic material during transcatheter aortic valve replacement (TAVR), with phased commercial launch to begin later this year Clearance was backed by extensive clinical data, incl. the PROTECT H2H IDE study assessing Emboliner vs. Sentinel Cerebral…

September 10, 2026

Lee’s Pharm Licenses 1cBio’s OC-3 in China and Southeast Asia

Shots: 1cBio & Lee's Pharmaceutical have entered into a licensing agreement granting Lee's Pharm exclusive rights to develop & commercialize OC-3, a preclinical PARP1 inhibitor, in China & certain countries in SE Asia As per the deal, 1cBio will receive an upfront payment, development milestones & potential sales milestone payments totaling ~$27M, as well as…

September 10, 2026

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for 1L Treatment of Non-Squamous HER2-Mutated NSCLC

Shots: The US FDA has granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic non-squamous NSCLC harboring HER2/ERBB2 TKD-activating mutations Approval was supported by ORR & DoR results from the Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo in treatment-naïve…

September 10, 2026

Nanoscope Therapeutics Reports the US FDA BLA Acceptance of Mogenry for Retinitis Pigmentosa

Shots: The US FDA has accepted BLA of Mogenry (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy designed for vision restoration for pts with retinitis pigmentosa (RP) having severe vision loss BLA was supported by the P-I/IIa trial, & the P-IIb/III (RESTORE) trial, where RESTORE met its 1 & 2EPs, showing improvements in visual acuity at…

September 9, 2026

MannKind and Rose Pharma Partner to Develop ROSE-010 Technosphere for Weight Management

Shots: Rose received exclusive global rights to MannKind’s Technosphere tech to develop & commercialize ROSE-010 Technosphere, a rapid-acting GLP-1 receptor agonist, with initial work focused on formulation re-establishment & optimization, followed by nonclinical & regulatory development MannKind will receive equity in Rose Pharma, the right to receive royalties on potential future net sales & board…

September 9, 2026

BMS Reports Topline P-II (QUINTESSENTIAL) Trial Data on Arlo-Cel for Heavily Pretreated R/R Multiple Myeloma (MM)

Shots: The P-II (QUINTESSENTIAL) trial assessed arlocabtagene autoleucel (arlo-cel) in r/r MM pts, who were previously treated with an immunomodulatory inhibitor, a proteasome inhibitor, an anti-CD38 therapy & a BCMA-targeted therapy The trial met its 1EP, showing improvement in ORR, & its key 2EP of CRR in the above-mentioned pts who had previously received ≥4L…

September 9, 2026

Pharvaris Reports the P-III (CHAPTER-3) Trial Data on Deucrictibant XR for Hereditary Angioedema (HAE)

Shots: Pharvaris has reported the P-III (CHAPTER-3) trial (N=85) assessing deucrictibant XR tablet (40mg, QD, PO; n=55) vs PBO (n=30) for the prevention of attacks in adolescents & adults with HAE Trial met all 1 & 2EPs, reducing monthly mean HAE attack rates by 83% overall & 87% in Type 1 or 2 HAE (n=80),…

September 9, 2026

NEWS

Ethris Secures €30M Financing to Advance Respiratory mRNA Programs

Genentech Secures the US FDA Priority Review for Enspryng (Satralizumab) to Treat MOGAD

Japan’s MHLW Approves GSK’s Shingrix PFS Presentation to Protect Individuals Against Shingles

Emboline Receives US FDA 510(k) Clearance for Emboliner Embolic Protection System

Lee’s Pharm Licenses 1cBio’s OC-3 in China and Southeast Asia

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for 1L Treatment of Non-Squamous HER2-Mutated NSCLC

Nanoscope Therapeutics Reports the US FDA BLA Acceptance of Mogenry for Retinitis Pigmentosa

MannKind and Rose Pharma Partner to Develop ROSE-010 Technosphere for Weight Management

BMS Reports Topline P-II (QUINTESSENTIAL) Trial Data on Arlo-Cel for Heavily Pretreated R/R Multiple Myeloma (MM)

Pharvaris Reports the P-III (CHAPTER-3) Trial Data on Deucrictibant XR for Hereditary Angioedema (HAE)

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