Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Shots: The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD) In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by…

ByRidhi Rastogi1 day ago

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InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)

Shots: Innocare has reported P-IIb trial data assessing orelabrutinib (50 or 75mg, QD, PO) vs PBO in 187 SLE pts for 48wks. & NMPA approval to initiate P-III trial Trial met its 1EP, with 75mg achieving a significantly higher SRI-4 response at Wk. 48 vs PBO (57.1% vs 34.4%) & showing dose-dependent efficacy over 50mg; 75mg…

ByRidhi RastogiDecember 16, 2025

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Imvax Reports P-IIb Trial Findings on IGV-001 to Treat Newly Diagnosed Glioblastoma

Shots: Imvax has reported the topline data from the P-IIb trial assessing IGV-001 vs PBO in 99 pts with newly diagnosed glioblastoma (ndGBM) Trial showed an mOS of 20.3 vs 14mos., with an mFU of 22mos. for all pts, plus IGV-001 demonstrated measurable patient benefit across various metrics; safety was consistent with previous studies Additionally,…

ByRidhi RastogiDecember 3, 2025

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RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

Shots: The US FDA has granted IND clearance to initiate P-IIb (prestIgE) trial of RPT904 for the treatment of pts with IgE-mediated food allergy by the end of 2025 The P-IIb (prestIgE) trial will assess RPT904 (SC; loading at Wk. 2, then Q8W or Q12W) vs PBO in 2 parts: In Part 1, ~100 pts with ≥1 food…

ByRidhi RastogiSeptember 30, 2025

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Bluejay Therapeutics Reports First Patient Enrolment in P-III (AZURE-2) Trial of Brelovitug for Chronic Hepatitis D

Shots: Bluejay Therapeutics has enrolled its first patient in the P-III (AZURE-2) trial assessing brelovitug (300mg, SC, QW) vs Hepcludex (bulevirtide) for the treatment of chronic hepatitis D Trial will assess the proportion of participants achieving a composite response at Wk. 48, defined as undetectable hepatitis D virus RNA along with normalization of alanine aminotransferase…

ByRidhi RastogiSeptember 5, 2025

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Zydus Reports Topline P-IIb/III (EPICS-III) Trial Data of Saroglitazar for Primary Biliary Cholangitis (PBC)

Shots: Zydus has reported topline P-IIb/III (EPICS-III) trial results in PBC pts resistant or intolerant to ursodeoxycholic acid (UDCA), where pts were randomized to Saroglitazar (1mg) or PBO, following optimal dose selection Trial met its composite 1EP, showing a 48.5% treatment difference in biochemical response, & also achieved its key 2EP with a higher proportion…

ByRidhi RastogiSeptember 1, 2025

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Camurus Receives the MHRA’s Approval for Oczyesa as Maintenance Treatment of Acromegaly

Shots: The UK’s MHRA has approved Oczyesa (octreotide SC depot) for the maintenance treatment in adult with acromegaly who have responded to & tolerated somatostatin analogs, following EC approval on Jun 30, 2025; UK launch expected in Q4’25 Approval was based on extensive data from 7 trials, incl. 4 P-I trials, 1 P-II trials &…

ByRidhi RastogiAugust 29, 2025

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Novo Nordisk Reports the Health Canada’s Approval of Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in T2D & CKD Adults

Shots: Health Canada has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes (T2D) & chronic kidney disease (CKD) Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs PBO (n=1766) in type 2 diabetes & CKD pts (N=3533) Study met its 1EP of 24% relative…

ByRidhi RastogiAugust 20, 2025

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Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease

Shots: Marea Therapeutics has dosed its first patient with MAR001 in P-IIb (TYDAL-TIMI 78) trial for adults at increased risk of atherosclerotic cardiovascular disease (ASCVD) Trial will evaluate MAR001 (300, 450, 900mg; Q4W) vs PBO in ~216 adults with elevated triglycerides & remnant cholesterol at high ASCVD risk, with the 1EP assessing % change from…

ByRidhi RastogiAugust 7, 2025

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Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma

Shots: Ethris has dosed the first pts in a P-IIa trial of ETH47 for asthma symptom reduction after rhinovirus challenge, building on P-I trial data, which showed strong respiratory tract activity, local IFNλ induction, antiviral gene activation, & no systemic exposure The P-IIa trial will evaluate ETH47 vs PBO in ~50 adults with asthma who…

ByRidhi RastogiAugust 5, 2025

Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)

Imvax Reports P-IIb Trial Findings on IGV-001 to Treat Newly Diagnosed Glioblastoma

RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

Bluejay Therapeutics Reports First Patient Enrolment in P-III (AZURE-2) Trial of Brelovitug for Chronic Hepatitis D

Zydus Reports Topline P-IIb/III (EPICS-III) Trial Data of Saroglitazar for Primary Biliary Cholangitis (PBC)

Camurus Receives the MHRA’s Approval for Oczyesa as Maintenance Treatment of Acromegaly

Novo Nordisk Reports the Health Canada’s Approval of Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in T2D & CKD Adults

Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease

Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma

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