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Astrazeneca
NEWS
AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC
Shots: AstraZeneca has reported P-III (FLAURA2) trial findings on Tagrisso + Pt-based CT as a 1L treatment of pts with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC The P-III (FLAURA2) trial assessed Tagrisso (80mg, QD, PO) + pemetrexed + cisplatin/carboplatin (Q3W for 4 cycles) followed by Tagrisso + pemetrexed maintenance (Q3W) vs…
September 8, 20250Comments
Takeda
NEWS
Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease
Shots: FDA has approved a label extension for Vonvendi to incl. routine prophylaxis for reducing bleeding in adults with Type 1 & 2 von Willebrand disease (VWD), & for on-demand & perioperative bleeding management in pediatric pts Approval was backed by extensive data, incl. a P-III trial in adults, a P-III trial in children, a P-IIIb continuation…
September 8, 20250Comments
WEEKLY SNAPSHOT
PharmaShots Weekly Snapshots (Sep 01, 2025 – Sep 05, 2025)   
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, Animal Health and Biosimilars. Check out our full report below:    Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)  Read More: Merck  AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat…
September 5, 20250Comments
NEWS
SignalPET Launches SignalPET 360° for Comprehensive Veterinary Radiology
Shots: SignalPET has launched SignalPET 360°, an integrated AI-powered radiology solution for veterinary medicine SignalPET 360 provides an integrated diagnostic platform with built-in PACS, allowing clinics to store & view all imaging modalities, generate AI-powered reports for every case, & seamlessly escalate to advanced AI or radiologist review when required SignalPET 360° suite provides immediate…
September 5, 20250Comments
Genentech
NEWS
Genentech Presents Long-Term Efficacy and Safety Data on Vabysmo for Wet Age-Related Macular Degeneration
Shots: Genentech has reported new data from the open-label AVONELLE-X & P-IIIb/IV (SALWEEN) studies of Vabysmo (faricimab-svoa) at Euretina’25 The 2yr. AVONELLE-X study was an extension of P-III (TENAYA & LUCERNE) trials, showing maintained vision & anatomy in wet AMD, with ~80% pts extending dosing to Q3M/Q4M after ~4yrs. of therapy SALWEEN study in Asia…
September 5, 20250Comments
NEWS
Bluejay Therapeutics Reports First Patient Enrolment in P-III (AZURE-2) Trial of Brelovitug for Chronic Hepatitis D
Shots: Bluejay Therapeutics has enrolled its first patient in the P-III (AZURE-2) trial assessing brelovitug (300mg, SC, QW) vs Hepcludex (bulevirtide) for the treatment of chronic hepatitis D Trial will assess the proportion of participants achieving a composite response at Wk. 48, defined as undetectable hepatitis D virus RNA along with normalization of alanine aminotransferase…
September 5, 20250Comments
NEWS
Pulmovant and Roivant’s Mosliciguat Receives MHLW’s Orphan Drug Designation for Pulmonary Hypertension Associated with Interstitial Lung Disease
Shots: Japan’s MHLW has granted ODD to mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) Mosliciguat (dry powder inhaler) is being evaluated in an ongoing global P-II (PHocus) trial against PBO among ~120 PH-ILD adults, with trial design to be presented at ERS Congress 2025 Mosliciguat is an sGC activator that…
September 5, 20250Comments
Eli lilly
NEWS
The US FDA Grants Breakthrough Therapy Designation to Eli Lilly’s Olomorasib for KRAS G12C-Mutant NSCLC
Shots: The US FDA has granted BTD to olomorasib + Keytruda for the 1L treatment of pts with unresectable advanced or metastatic NSCLC harboring KRAS G12C mutation & PD-L1 expression ≥ 50% Designation was based on P-I/II (LOXO-RAS-20001) trial of olomorasib monotx. & dose optimization portion from P-III (SUNRAY-01) trial of olomorasib + Keytruda ±…
September 5, 20250Comments