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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…
February 6, 2025

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Astrazeneca
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…
February 6, 2025

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Gradalis
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…
February 6, 2025

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Astellas
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…
February 5, 2025

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Roche
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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…
February 5, 2025

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J&J
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…
February 4, 2025

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Bavarian Nordic
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Bavarian Nordic Receives CHMP’s Positive Opinion for Vimkunya to Prevent Chikungunya

Shots: The CHMP has recommended Vimkunya (pre-filled syringe) against CHIKV disease in individuals (≥12yrs.), with the EC’s decision & launch expected in H1’25 for the EU, Iceland, Liechtenstein, & Norway Opinion was based on 2 P-III studies showing a rapid immune response in 1wk. with ~97.8% of participants (n=3,500) developing neutralizing antibodies by day…
February 3, 2025

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Novo-Nordisk
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Novo Nordisk Reports the US FDA’s Approval for Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in Type 2 Diabetes & Chronic Kidney Disease (CKD) Adults

Shots: The US FDA has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes & CKD Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs matching PBO (n=1766) in type 2 diabetes & CKD pts (N=3533) Study met its 1EP of 24% relative…
February 3, 2025

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MERCK
NEWS

Merck Receives CHMP’s Positive Opinion for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for Invasive Pneumococcal Disease (IPD)

Shots: The CHMP has recommended Capvaxive for active immunization against invasive disease & pneumonia caused by Streptococcus pneumoniae in adults (≥18yrs.), with the EC’s decision expected in Q2’25 for EU, Iceland, Liechtenstein and Norway. Ongoing regulatory review in Japan, plus multiple filings are underway Opinion was backed by P-III (STRIDE-3) data, assessing Capvaxive vs PCV20…
February 3, 2025

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