Abbvie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI)

Shots: The US FDA has approved Emblaveo (IV) + metronidazole for pts (≥18 yrs) with few or no therapy options for cIAI caused by susceptible gram -ve bacteria, incl. E. coli, K. pneumoniae, K. oxytoca, ECC, C. freundii complex, & S. marcescens; commercially available in Q3’25 Approval was based on prior aztreonam’s efficacy & safety data…

ByRidhi RastogiFebruary 10, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 3, 2025 – February 7, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health & DigiHealth. Check out our full report below: Algiax Pharmaceuticals Reports Topline Data from P-IIa Trial of AP-325 for Neuropathic Pain Read More: Algiax Pharmaceuticals Pfizer Reveals Data from the P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic…

BySenior EditorFebruary 7, 2025

NEWS

The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease

Shots: The US FDA has approved Onapgo injection (SPN-830; SC infusion device) to treat motor fluctuations in adults with advanced Parkinson’s disease; commercially available in Q2’25 Approval was based on a 12wk P-III trial assessing Onapgo (n=53) vs PBO (n=51) in Parkinson’s pts (N=107), evaluating 1EP of mean change in total daily OFF time…

ByRidhi RastogiFebruary 7, 2025

NEWS

Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

Shots: The US FDA has granted FTD to ADI-001 for treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement Adicet Bio is advancing ADI-001 in six autoimmune indications, with patient enrollment ongoing in the P-I LN study. Enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff…

ByRidhi RastogiFebruary 6, 2025

NEWS

AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots: The CHMP has recommended Imfinzi for the treatment of LS-SCLC pts whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Opinion was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi…

ByRidhi RastogiFebruary 6, 2025

NEWS

Accord Healthcare (Intas) Receives EC Approval for Hetronifly (Serplulimab) as 1L Treatment of ES-SCLC

Shots: The EC has approved Hetronifly + CT (carboplatin & etoposide) as a 1L treatment for extensive-stage small cell lung cancer (ES-SCLC) pts. Serplulimab, an anti-PD-1 mAb for 1L SCLC therapy, is approved in China and several SEA countries. ESMO rates it 4/5 on the MCBS for ES-SCLC. Its trial results were published in…

ByRidhi RastogiFebruary 6, 2025

NEWS

The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer

Shots: The US FDA has granted RMAT designation to Vigil (gemogenovatucel-T) as a maintenance therapy for newly diagnosed advanced Stage IIIb/IV HRP ovarian cancer pts with cTMB-H who achieved complete response post-debulking surgery & frontline Pt-based doublet CT Designation was backed by ongoing P-IIb (VITAL) trial assessing Vigil vs PBO showed improved RFS (1EP) in all…

ByRidhi RastogiFebruary 6, 2025

NEWS

Japan’s MHLW Receives NDA for Conditional Approval of Astellas’ Avacincaptad Pegol to Treat Geographic Atrophy

Shots: Japan’s MHLW has received NDA for conditional approval of avacincaptad pegol (ACP) to treat geographic atrophy (GA) secondary to AMD Submission was backed by the P-II/III (GATHER1) & P-III (GATHER2) trials assessing safety & efficacy of ACP (2mg, Q1M, intravitreal) in pts with GA secondary to AMD Data from both trials showed reduced…

ByRidhi RastogiFebruary 5, 2025

NEWS

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME)

Shots: The US FDA has approved Susvimo (port delivery platform with Lucentis) to treat DME Approval was based on P-III (Pagoda) study assessing Susvimo (100 mg/mL, refilled in Q6M) vs Lucentis (0.5mg, intravitreal, Q1M) in DME pts (n=634), where subjects in Susvimo arm received 4 loading doses of Lucentis till 16wks. prior to implantation Study demonstrated sustained vision…

ByRidhi RastogiFebruary 5, 2025

NEWS

Johnson & Johnson Receives the CHMP Positive Opinion on Label Extension to SC Rybrevant for the Treatment of Advanced EGFR-Mutated NSCLC

Shots: The CHMP recommended label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT Opinion was backed by P-III (PALOMA-3) trial, evaluating SC vs…

ByDipanshu DixitFebruary 4, 2025

Abbvie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI)

PharmaShots Weekly Snapshots (February 3, 2025 – February 7, 2025)

The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease

Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Accord Healthcare (Intas) Receives EC Approval for Hetronifly (Serplulimab) as 1L Treatment of ES-SCLC

The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer

Japan’s MHLW Receives NDA for Conditional Approval of Astellas’ Avacincaptad Pegol to Treat Geographic Atrophy

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME)

Johnson & Johnson Receives the CHMP Positive Opinion on Label Extension to SC Rybrevant for the Treatment of Advanced EGFR-Mutated NSCLC

Contact US

FOLLOW US