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Pfizer Reveals Data from P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic Colorectal Cancer

Shots:Pfizer reported topline data of P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in untreated BRAF V600E-mutant mCRC pts, randomized to Braftovi + Erbitux (n=158), Braftovi + Erbitux + mFOLFOX6 (n=236), or CT (mFOLFOX6/ FOLFOXIRI/ CAPOX) ± Avastin (n=243) Study showed improved PFS (1EP) & OS (2EP) along with previously reported improved cORR…
February 4, 20250Comments

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Algiax Pharmaceuticals Reports Topline Data from P-IIa Trial of AP-325 for Neuropathic Pain

Shots:Algiax reported topline data from the P-IIa PoC trial assessing AP-325 (GABA-A modulator) vs PBO in 99 pts with peripheral post-surgical neuropathic pain in Germany, Spain, the Czech Republic, Belgium, & France Data showed rapid PI-NRS reduction in <2wks., sustained effects, plus significantly higher ≥50% & ≥70% responder rates with ~25% vs. 11% pts…
February 4, 20250Comments

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Datar Cancer Genetics Launches Exacta AI to Offer Personalized Treatment Options for Cancer Patients

Shots:Datar Cancer Genetics has introduced Exacta AI (multi-analyte platform) to provide ~10 evidence-based drug combinations as a treatment for cancer patients who have exhausted SoC options Exacta AI integrates 360° tumor work-up with AI-driven analysis of complex tumor interactome data to assess drug interactions, toxicity, & side effects for ADCs, CPIs, targeted therapies,…
February 4, 20250Comments

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News

Vanda Pharmaceuticals Enters into an Exclusive Global License Agreement with AnaptysBio to Develop and Commercialize Imsidolimab

Shots:Vanda received exclusive rights to develop, manufacture & commercialize imsidolimab which has completed 2 P-III (GEMINI-1 & GEMINI-2) trials for generalized pustular psoriasis As per the terms, Anaptys will get $10M upfront, $5M for existing drug supply, & ~$35M in regulatory & sales milestones, plus 10% royalty on net sales, whereas Vanda will…
February 4, 20250Comments

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J&J
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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, 20250Comments

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Key Biosimilars Events of January 2025
INSIGHTS+

Key Biosimilars Events of January 2025

Shots:      Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency       Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients       A major highlight was the Samsung Bioepis & Teva Partners to Commercialize Epysqli in…
February 4, 20250Comments

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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, 20250Comments

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News

Jupiter Neurosciences Collaborates with Zina Biopharmaceuticals to Advance Jotrol in P-II Trial for Parkinson’s Disease

Shots:Jupiter has partnered with Zina to support its P-IIa trial of Jotrol for assessing its safety & tolerability (1EP), and PK/PD (2EP) in Parkinson’s pts As per the agreement, Zina will provide services for P-IIa trial such as protocol design assistance (PK, biomarkers), regulatory strategy, & trial site selection Jotrol (micellar formulation)…
February 3, 20250Comments

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