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NEWS

Amgen
Amgen Reports the MHRA’s Approval of Tepezza to Treat Thyroid Eye Disease
Shots: UK’s MHRA has approved Tepezza (teprotumumab) for the treatment of adult pts with mod. to sev. thyroid eye disease (TED) Approval was based on extensive clinical data incl. P-III (OPTIC) trial (n=83), P-II (TED01RV) trial (n=88), P-IV (HZNP-TEP-403) trial (n=62) & P-III (OPTIC-J) trial in Japan (n=54) OPTIC trial showed that 83% (34/41) of…
Astrazeneca
AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)
Shots: The EC has approved Calquence + bendamustine & rituximab for the treatment of ASCT-ineligible pts with previously untreated MCL; regulatory review is ongoing in Japan & other regions Approval was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed improved PFS of 27%,…
Viverita and Boehringer Ingelheim
ViVerita Therapeutics Collaborates with Boehringer Ingelheim to Accelerate Discovery of Novel Therapeutic Targets in Oncology
Shots: ViVerita Therapeutics & BI have entered into a strategic research collaboration to accelerate discovery & validation of novel cancer targets. Although financial terms of the deal were not disclosed As per the deal, ViVerita will utilize its in vivo CRISPR discovery platform to study selected potential targets from BI, evaluating their functions in physiologically relevant…
Astrazeneca and Daiichi-Sankyo New
Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer
Shots: Daiichi Sankyo & AstraZeneca has reported topline P-III (DESTINY-Breast11) trial data assessing neoadj. Enhertu (5.4mg/kg) monotx. or Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) vs SoC + THP in high-risk, locally advanced HER2+ early-stage breast cancer pts (n=927) Trial showed that Enhertu regimen achieved significant improvement in pCR rate (1EP), while EFS (2EP) data was…
TriviumVet
PBI-Gordon Companies Acquires TriviumVet, Expanding its Animal Healthcare Product Portfolio
Shots: PBI-Gordon Companies has acquired TriviumVet, incl. its product Felycin-CA1 (Sirolimus Delayed-Release Tablets), adding it to the PRN Pharmacal portfolio (PBI-Gordon’s Brand) to expand its animal healthcare product portfolio Felycin-CA1 will be available for veterinary orders by Aug 2025, with PRN Pharmacal expanding its team by hiring over 50 additional employees Felycin-CA1 has been conditionally…