Shots:
The CHMP has recommended elinzanetant for treating mod. to sev. vasomotor symptoms linked with menopause or caused by AET related to breast cancer based on P-III (OASIS-1, 2, 3 & 4) trials
OASIS-1 & 2 showed reduced mod. to sev. menopausal VMS vs. PBO at wks. 4 & 12, with >80% pts (incl. those…
Shots:
ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care
In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…
Shots:
The US FDA has accepted NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. neonates; MAA was submitted to MHLW & EMA with further filings planned in other regions
NDA was supported by the QUANTI clinical program, which incl.…
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…
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…
Shots:
Bayer has entered into an exclusive global license agreement & collaboration with Kumquat Biosciences to develop and commercialize its KRAS G12D inhibitor
Kumquat will initiate & complete the P-Ia study following FDA’s IND clearance in Jul 2025, while Bayer handles further development & commercialization, with Kumquat holding an exclusive option to negotiate US profit-loss…
Shots:
The EC 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…
Shots:
The US FDA has approved Kerendia/Firialta (10, 20, & 40mg) for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits authorization in China, EU & Japan, with global applications planned
Approval was based on the P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where…
Shots:
The US FDA has received NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. term neonates; MAA was submitted to MHLW with further filings planned in coming mos.
NDA was supported by the QUANTI clinical program, which incl. 2…
Shots:
The US FDA has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts; approval process in the EU is ongoing
Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC pts
Trial showed a 46% reduction in rPFS (1EP),…

