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NEWS

Amgen
Amgen Receives the US FDA Approval for Lumakras + Vectibix to Treat Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer (mCRC)
Shots: The FDA has approved Lumakras + Vectibix combination to treat metastatic KRAS G12C-mCRC in adults diagnosed via FDA approved test, receiving fluoropyrimidine-, oxaliplatin- & irinotecan-based CT The approval was based on P-III (CodeBreaK 300) Trial assessing Lumakras (960mg/240mg, QD) + Vectibix vs investigator’s choice of SoC (n=54; trifluridine/tipiracil or regorafenib) in patients …
January 20, 2025
InflaRx
InflaRx’s Gohibic (Vilobelimab) Receives the EC Approval for the Treatment of ARDS
Shots: The EC has approved (under exceptional circumstances) Gohibic to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on SoC (incl. systemic corticosteroids) & IMV (with/without ECMO) Approval was backed by results of the P-III (PANAMO) study assessing Gohibic vs. PBO among invasively mechanically ventilated COVID-19 patients in the ICU, which showed improvement in survival with…
January 17, 2025
Ceva Animal Health Partners with Touchlight to Use its dbDNA Technology in Animal Healthcare
Shots: Ceva & Touchlight entered into an agreement & long-term collaboration for developing & manufacturing future animal health products, integrating the former’s development & marketing expertise with Touchlight’s dbDNA tech to develop DNA vaccines As per the agreement, Touchlight is entitled to upfront payment, development milestones & sales-based royalties, while the complete financial terms…
January 17, 2025
Biothera and World Medicine Partners to Commercialize BAT2206 (Biosimilar: Ustekinumab) in Turkey
Shots: Bio-Thera & World Medicine entered into an exclusive license & commercialization agreement for BAT2206, a biosimilar to Janssen’s Stelara (ustekinumab), leveraging World Medicine’s marketing expertise & distribution network in Turkey As per the terms, World Medicine will hold market approval of BAT2206 in Turkey as well as its registration, imports, promotion & marketing, while…
January 17, 2025
J&J
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
Sutter Health Collaborates with GE HealthCare to Enhance Patient Care Through AI-Powered Imaging for Physicians and Clinicians
Shots: Sutter Health and GE HealthCare signed a 7yrs. strategic collaboration agreement (Care Alliance), to enhance access to imaging services for patient and clinician experiences in California. This will enable faster appointments, quicker imaging results, and more consistent care Sutter Health's key initiatives include a fast technology program to deploy advanced AI imaging tools…
January 17, 2025
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