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InnoCare and KeyMed Together Partner with Prolium Bioscience to Develop ICP-B02
Shots: InnoCare & KeyMed together have signed an exclusive license agreement with Prolium to develop & commercialize ICP-B02 (CM355) Prolium gains exclusive rights to develop, manufacture & commercialize ICP-B02 globally (non-oncology) and in ex-Asia regions (oncology) while InnoCare & KeyMed will get a total of ~$520M (upfront & near-term payments), minority equity stake in…
January 21, 2025
Formycon Reports the EC’s Approval of FYB203 (Biosimilar, Eylea) Under the Brand Names Ahzantive and Baiama
Shots: Formycon & Klinge Biopharma have reported the EC’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand names: Ahzantive & Baiama valid across the EU plus Iceland, Liechtenstein & Norway after receiving the CHMP’s recommendation in Nov 2024 The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other…
January 21, 2025
Daiichi Sankyo & Astrazeneca
Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer
Shots: The FDA has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients receiving endocrine-based therapy & CT. Submissions are under review in the EU, China, & other areas Approval was based on a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D)…
January 20, 2025
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
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