Skip to content Skip to footer
Subscribe Now
J&J
NEWS

Johnson & Johnson Submits NDA to the US FDA for TAR-200 to Treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC)

Shots: FDA received NDA of TAR-200 (J&J) for the treatment of Bacillus Calmette-Guérin (BCG) -unresponsive HR-NMIBC with CIS &/or papillary tumors the application will be reviewed under RTOR pathway, following receipt of BTD in Dec 2023 The NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in patients ineligible or opting out of…
January 17, 2025

Read more

Innovent
NEWS

Innovent’s IBI343 Secures the NMPA’s Breakthrough Therapy Designation for Advanced Pancreatic Cancer

Shots: The NMPA has granted BTD to IBI343 alone for treating CLDN18.2+ advanced pancreatic ductal adenocarcinoma (PDAC) progressed post 1L of systematic therapy Designation was based on the ongoing P-I trial of IBI343 (6mg/kg, Q3W) in CLDN18.2+ advanced PDAC patients (n=43) treated with at least 1L of therapy (5% received 2L+ of therapy) across…
January 16, 2025

Read more

Eli lilly
NEWS

Eli Lilly Receives the US FDA’s Approval for Omvoh (Mirikizumab-mrkz) to Treat Crohn’s Disease (CD)

Shots: Approval was based on a P-III (VIVID-1) trial assessing Omvoh vs PBO in mod. to sev. CD patients, unresponsive/intolerable to corticosteroids, BRMs &/or biologics, post its approval for UC in Dec 2023. Regulatory submissions are filed globally, incl. Japan & the EU, with other submissions underway Study showed 53% vs 36% clinical remission &…
January 16, 2025

Read more

Hutchmed
NEWS

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

Read more

NEWS

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

Read more

Regeneron New
NEWS

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

Read more

Astrazeneca & Daiichi Sankyo
NEWS

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

Read more

J&J
NEWS

Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias

Shots: The CE mark of Thermocool Smarttouch SF Catheter for cardiac arrhythmias was based on SmartfIRE trial in European patients with refractory PAF that depicted 100% acute success rate & first-pass isolation achievement in 96.8% of veins (published in Apr 2024). The Trupulse Generator hardware compatibility is anticipated in H1’25 The company has concluded…
January 13, 2025

Read more

Load more