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Hutchmed
HUTCHMED’ Orpathys (Savolitinib) Receives the NMPA’s Full Approval for Locally Advanced or Metastatic MET Exon 14 NSCLC
Shots: The NMPA has granted sNDA approval of Orpathys to treat locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, expanding its indication to include both treatment-naïve & experienced patients. Previous conditional approval is also converted to full approval Approval was based on P-IIIb study, with preliminary data from the first line…
January 15, 2025
Neurogen Partners with Linus Health to Develop Early Detection Technology for Mild Cognitive Impairment and Dementia due to Alzheimer’s Disease
Shots: Neurogen Biomarking partnered with Linus Health to form a unified platform by incorporating the latter’s digital cognitive assessments with the Neurogen Biomarking ecosystem, commercially available in Q1’25 The new platform will integrate early detection & care for patients with MCI or dementia related to AD with Linus Health’s scientifically validated assessments to identify…
January 15, 2025
Regeneron New
Regeneron Reports Interim Data from P-III (C-POST) Trial of Libtayo Adjuvant to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)
Shots: The P-III (C-POST) trial assessed Libtayo adj. (n=205; 350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.) vs PBO (n=204) to treat high-risk CSCC patients (N=415) for ~48wks. Study met its first prespecified interim analysis, showing 68% reduced disease occurrence & death risk at 24mos. median follow-up, with additional…
January 15, 2025
Astrazeneca & Daiichi Sankyo
AstraZeneca and Daiichi Sankyo Report the US FDA’s BLA Acceptance of Datopotamab Deruxtecan with Priority Review for EGFR-mutated NSCLC
Shots: FDA has accepted & granted priority review to the BLA of datopotamab deruxtecan (Dato-DXd) for treatment-experienced patients with LA/M EGFR-mutated NSCLC (PDUFA: Q3’25) which also received BTD from US FDA BLA & designation were based on P-II (TROPION-Lung05) & P-III (TROPION-Lung01) trials along with supporting data from P-I (TROPION-PanTumor01) study. The combined findings…
January 15, 2025
Eli Lilly Inks ~2.5B Deal to Acquire Scorpion Therapeutics
Shots: Eli Lilly to acquire Scorpion, plus its leading asset STX-478, for ~2.5B in cash, incl. upfront, regulatory & sales milestones through a definitive agreement As per the terms, Scorpion will form an independent company owned by its current shareholders with Lilly’s minority stake to hold its employees & non-PI3Kα pipeline assets STX-478 (oral,…
January 14, 2025
Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in EU & Israel
Shots: Teva Pharmaceuticals International secured semi-exclusive marketing rights for FYB203, a biosimilar of Eylea (aflibercept), in Europe (excl. Italy) & Israel via a deal with Klinge & Formycon, boosting Teva’s biosimilar portfolio The deal combines Teva’s commercial expertise & distribution network with Formycon’s biosimilar development capabilities, following their successful collaboration on marketing FYB201, a…
January 14, 2025
The US FDA Grants Fast Track Designation to BridgeBio Oncology Therapeutics’ BBO-8520 for KRASG12C-Mutated Metastatic Non-Small Cell Lung Cancer
Shots: The US FDA has granted FTD to BBO-8520 for the treatment of metastatic NSCLC with KRAS^G12C mutations in adults BBO-8520 showed significant tumor inhibition in preclinical models, post resistance to sotorasib.  In addition, BBO-8520 is being assessed in a P-I (ONKORAS-101) trial in KRAS^G12C NSCLC patients either receiving KRAS^G12C inhibitors or no targeted…
January 14, 2025
Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine in P-I Trial to Treat 1L Acute Myeloid Leukemia (AML)
Shots: The first patient was dosed with iadademstat (ORY-1001) + venetoclax + azacitidine combination to treat AML naïve patients (n=45) under the P-I trial to evaluate the safety, tolerability, preliminary efficacy & optimal dose. Trial will be managed & funded by NCI under CRADA In addition, the combination is being evaluated to treat 1L…
January 14, 2025
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