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Bayer
NEWS
Bayer Reports Health Canada’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Shots: Health Canada has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…
August 22, 20250Comments
Ionis
NEWS
Ionis Reports the US FDA’s Approval of Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)
Shots: The US FDA has approved Dawnzera (donidalorsen; 80mg SC, Q4W/Q8W) as a prophylactic treatment against attacks in pts (≥12yrs.) with hereditary angioedema; available in the US in coming days Approval was based on P-III (OASIS-HAE) trial & OASISplus OLE study, where P-III showed 81% fewer monthly HAE attacks over 24wks. (87% from 2nd dose) &…
August 22, 20250Comments
TOP 20
Top 20 R&D Spending Biopharma Companies of 2025  
Shots:  Research and Development (R&D) serves as the driving force behind groundbreaking therapeutic innovations, laying the foundation for advancements that transform patient health and overall well-being  The global Top 20 pharmaceutical leaders spent ~$180B in 2024, with Merck & Co. contributing the most with a whopping $17.93B, followed by Johnson & Johnson ($17.23B) and Roche…
August 21, 20250Comments
NEWS
Agilent Technologies Reports the US FDA’s Approval of MMR IHC Panel pharmDx (Dako Omnis) as a Companion Diagnostic Test for Colorectal Cancer
Shots: Agilent Technologies has received the US FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic (CDx) test for colorectal cancer Agilent & BMS partnered to develop the MMR IHC Panel pharmDx (Dako Omnis) to identify dMMR colorectal cancer pts eligible for Opdivo monotx. or Opdivo + Yervoy treatment The…
August 21, 20250Comments
NEWS
neurocare Receives the US FDA’s Clearance for Apollo TMS Therapy Devices to Treat Obsessive Compulsive Disorder
Shots: neurocare has received US FDA clearance for its Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices to treat obsessive-compulsive disorder (OCD) The Apollo TMS Therapy system is a non-invasive treatment that uses a magnetic coil on the head to stimulate targeted brain pathways and was previously cleared for major depressive disorder The systems support advanced…
August 21, 20250Comments