Gilead Highlights P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC) at ESMO 2025

Shots:The P-III (ASCENT-03) trial (n= 558) assessed Trodelvy (sacituzumab govitecan-hziy; 10mg/kg, IV, Day 1 & 8 of 21-day cycle) vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who were previously treated with a PD-L1 inhibitorTrial met its 1EP of improved PFS by 38% (mPFS:…

ByRidhi RastogiOctober 22, 2025

NEWS

Regeneron Reports the CHMP’s Positive Opinion for Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots:The CHMP has recommended Libtayo (cemiplimab) as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiationOpinion was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.; n=209) vs PBO (n=206) to treat…

ByRidhi RastogiOctober 21, 2025

NEWS

Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots:The US FDA has approved Libtayo (cemiplimab-rwlc) under priority review as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation; application under EMA’s review, with decision expected in H1’26Approval was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks.…

ByRidhi RastogiOctober 9, 2025

NEWS

Merck Presents P-III (HYPERION) Trial Data of Winrevair (sotatercept-csrk) for Pulmonary Arterial Hypertension at ERS 2025

Shots:The P-III (HYPERION) trial assessed Winrevair vs PBO, both with background therapy in recently diagnosed adults (n=320) with PAH (WHO Group 1) FC II or III at intermediate or high risk of disease progressionTrial showed 76% reduction in clinical worsening, where 10.6% vs 36.9% pts experienced ≥1 event, with treatment benefit seen in…

ByRidhi RastogiSeptember 30, 2025

NEWS

Intellia Reports Long-Term P-I Trial Data of Nexiguran Ziclumeran for Hereditary ATTR Amyloidosis with Polyneuropathy (ATTRv-PN)

Shots:Intellia has reported P-I trial data assessing nexiguran ziclumeran (nex-z) in ATTRv-PN; results were presented at the International ATTR Amyloidosis Meeting 2025 & published in The NEJMSingle dose of nex-z achieved mean TTR reductions of 92% at 24mos. & 90% in 12 pts followed for 36mos. At 24mos., 13/18 pts met ≥4-point mNIS+7 improvement, incl.…

ByRidhi RastogiSeptember 26, 2025

NEWS

AstraZeneca and Amgen Report the CHMP’s Positive Opinion of Tezspire (Tezepelumab) for CRSwNP

Shots:The CHMP has recommended Tezspire for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); regulatory review is ongoing in the US, China, Japan & other countriesOpinion was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by a post-treatment follow-up duration…

ByRidhi RastogiSeptember 24, 2025

NEWS

Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome

Shots:The EC has approved Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndromeApproval was based on P-III (Balance) trial assessing Tryngolza (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute pancreatitis events over 12mos.; data…

ByRidhi RastogiSeptember 23, 2025

NEWS

Bayer Reports the CHMP’s Positive Opinion of Elinzanetant to Treat Vasomotor Symptoms

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) trialsOASIS-1 & 2 showed reduced mod. to sev. menopausal VMS vs. PBO at wks. 4 & 12, with >80% pts (incl. those…

ByRidhi RastogiSeptember 23, 2025

NEWS

The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants

Shots:The CHMP has recommended Enflonsia to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season, with potential approval valid in all 30 EEA statesOpinion was based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk…

ByRidhi RastogiSeptember 22, 2025

NEWS

AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

Shots:The P-III (BaxHTN) trial assessed baxdrostat (1 or 2mg) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment resistant hypertension over 12wks.; P-III (Bax24) trial readout is expected in late 2025Trial met its 1EP, reducing mean seated SBP at 12wks. by 15.7 (2mg) & 14.5 mmHg (1mg), with PBO-adjusted…

ByRidhi RastogiSeptember 1, 2025

Gilead Highlights P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC) at ESMO 2025

Regeneron Reports the CHMP’s Positive Opinion for Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Merck Presents P-III (HYPERION) Trial Data of Winrevair (sotatercept-csrk) for Pulmonary Arterial Hypertension at ERS 2025

Intellia Reports Long-Term P-I Trial Data of Nexiguran Ziclumeran for Hereditary ATTR Amyloidosis with Polyneuropathy (ATTRv-PN)

AstraZeneca and Amgen Report the CHMP’s Positive Opinion of Tezspire (Tezepelumab) for CRSwNP

Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome

Bayer Reports the CHMP’s Positive Opinion of Elinzanetant to Treat Vasomotor Symptoms

The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants

AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

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