The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: The EMA has accepted MAA of Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors, based on an ongoing QUILT 3.032 study. Application covers 27 EU countries, plus Iceland, Norway & Liechtenstein, with submission also made to the UK's MHRA As of the data cut-off on Jul…

ByDipanshu DixitJanuary 29, 2025

NEWS

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Shots: The EMA accepted depemokimab’s MAA 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, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…

BySenior EditorJanuary 28, 2025

NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Shots: The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…

BySenior EditorJanuary 28, 2025

NEWS

Dyne Therapeutics’ DYNE-101 Secures the US FDA’s Fast Track Designation for Treating DM1

Shots: The US FDA has granted FTD to DYNE-101 for treating myotonic dystrophy type 1 (DM1). US Accelerated Approval is anticipated to submit in H1’26 DYNE-101 is being tested in the global P-I/II ACHIEVE trial for DM1 DYNE-101 is an antisense oligonucleotide (ASO) linked to an antibody fragment (Fab) that targets the transferrin…

ByDipanshu DixitJanuary 27, 2025

NEWS

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

Shots: China’s NMPA has accepted an NDA for gumokimab (AK111) to treat mod. to sev. plaque psoriasis based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 96% & an sPGA 0/1 response nearing 90%. PASI 90 hit ~80%, &…

ByRidhi RastogiJanuary 27, 2025

NEWS

The US FDA Grants Fast Track Designation to Clarity’s Cu-64 SAR-BisPSMA in Biochemical Recurrence of Prostate Cancer

Shots: FDA has granted FTD to Cu-64 SAR-bisPSMA for PET scans of PSMA+ lesions in pts with BCR post-receiving SoC, based on a P-I/II (COBRA) trial assessing it (same & next day) in patients who had an SoC scan at study entry Study showed that it localized disease in ~80% patients & detected double the…

ByRidhi RastogiJanuary 27, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 20, 2025 – January 24, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, DigiHealth, MedTech, Biosimilars, Animal Health & Biotech. Check out our full report below: Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes Read More: Novo Nordisk Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat…

BySenior EditorJanuary 24, 2025

NEWS

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Shots: The US FDA has granted Orphan Drug Designation to Zai Lab’s ZL-1310 for treating small cell lung cancer (SCLC) The designation is based on promising P-Ia/Ib trial data of ZL-1310 as monotherapy and with atezolizumab in treatment-experienced ES-SCLC patients, presented at the ENA Symposium 2024 ZL-1310 is a novel ADC targeting DLL3…

ByRidhi RastogiJanuary 23, 2025

NEWS

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

Shots: The US FDA has granted FTD to SGT-212 for treating Friedreich’s ataxia (FA) and previously approved its IND on Jan 07, 2025 The P-Ib study will assess safety & tolerability of contemporaneous systemic IV and bilateral IDN administration of SGT-212 in non-ambulatory and ambulatory FA patients for 5yrs., with dosing anticipated during H2’25…

BySenior EditorJanuary 22, 2025

NEWS

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM patients, following the CHMP’s positive opinion. Regulatory findings are under review in Japan & China Approval was based on a P-III (IMROZ) study assessing Sarclisa + VRd vs VRd, which showed improved PFS of 40% (1EP) with findings reported…

ByRidhi RastogiJanuary 22, 2025

The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Dyne Therapeutics’ DYNE-101 Secures the US FDA’s Fast Track Designation for Treating DM1

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

The US FDA Grants Fast Track Designation to Clarity’s Cu-64 SAR-BisPSMA in Biochemical Recurrence of Prostate Cancer

PharmaShots Weekly Snapshots (January 20, 2025 – January 24, 2025)

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

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