Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration

Shots: Merck initiates the P-IIb/III (MALBEC) trial assessing MK-8748 (Tiespectus/EYE201) for the treatment of neovascular (wet) age-related macular degeneration (NVAMD) The trial will assess the safety & efficacy of two intravitreal dose levels of MK-8748 vs aflibercept (2mg), with Q4W dosing initially for 3mos., then Q8W through Wk. 48, followed by individualized dosing intervals, with…

ByRidhi RastogiApril 3, 2026

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ViiV Healthcare Reports P-IIb (EMBRACE) Trial Data on Lotivibart + Cabotegravir for HIV Treatment

Shots: ViiV Healthcare has reported 12mos. interim data from P-IIb (EMBRACE) trial assessing lotivibart (IV or SC, Q4M) + cabotegravir (CAB LA; IM, QM) vs SoC for the treatment of HIV lotivibart + cabotegravir maintained viral suppression in 94% of lotivibart IV & 82% of SC recipients vs 88%, with confirmed virologic failure in 4%…

ByRidhi RastogiFebruary 26, 2026

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Johnson & Johnson Highlights QUASAR LTE Data on Tremfya (Guselkumab) in Ulcerative Colitis at ECCO 2026

Shots: J&J has reported the long-term data from the QUASAR LTE trial in pts with mod. to sev. active ulcerative colitis, showing lasting disease control for patients The P-IIb/III (QUASAR) trial assessed Tremfya (IV induction: 200mg Q4W; SC maintenance: 100mg, Q8W or 200mg, Q4W) vs PBO in UC pts At Wk. 140, ~89% completed treatment,…

ByRidhi RastogiFebruary 23, 2026

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Teva and Sanofi Report P-IIb (RELIEVE UCCD) LTE Study Data on Duvakitug in Inflammatory Bowel Disease

Shots: Teva & Sanofi have reported RELIEVE UCCD LTE study data evaluating duvakitug (450 or 900mg, SC, Q4W) in 130 pts with ulcerative colitis (UC) or Crohn’s disease (CD) following P-IIb (RELIEVE UCCD) induction study Trial showed that at Wk. 44 of maintenance, 58% (900mg) & 47% (450mg) of UC pts achieved clinical remission per mMS,…

ByRidhi RastogiFebruary 17, 2026

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Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Shots: Lundbeck has reported P-IIb (PROCEED) trial results evaluating bocunebart (SC/IV; QM for 3mos.) vs PBO in migraine patients with prior failure of 1-4 preventive therapies, with the IV arm randomizing 431 pts across 14 countries Trial met its 1EP in the multiple IV dosing arm, showing a statistically significant reduction in monthly migraine days…

ByRidhi RastogiFebruary 16, 2026

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Pfizer Reports P-IIb (VESPER-3) Trial Results on PF’3944 in Weight Management

Shots: Assessing PF’3944 (QW titration to QM) in obese/overweight pts without T2D, the trial randomized pts to Arm 1 (0.4mg QW/ 0.8mg QW/ 3.2mg QM), Arm 2 (0.8mg QW/ 3.2mg QM), Arm 3 (0.4mg QW/ 0.8mg QW/ 1.2mg QW/ 4.8mg QM), Arm 4 (0.6mg QW/ 1.2mg QW/ 4.8mg QM), or Arm 5 (PBO) Trial met…

ByRidhi RastogiFebruary 4, 2026

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PharmaEssentia Reports the US FDA’s sBLA Acceptance of Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia

Shots: The US FDA has accepted sBLA of ropeginterferon alfa-2b-njft for the treatment of adults with essential thrombocythemia, with a PDUFA target action date of Aug 30, 2026 sBLA is supported by the statistically significant and clinically meaningful data from the P-III (SURPASS-ET) trial as well as North American P-IIb (EXCEED-ET) trial Ropeginterferon alfa-2b-njft received…

ByRidhi RastogiJanuary 14, 2026

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Teva and Royalty Pharma Enter Funding Agreement to Accelerate TEV-’408 Development in Vitilgo

Shots: Teva has entered into a funding agreement with Royalty Pharma to accelerate the clinical development of Teva’s TEV-’408 for the treatment of vitiligo As per the deal, Teva will receive ~$500M to support TEV-‘408 development costs, incl. $75M in R&D co-funding for a P-IIb study planned for 2026. Royalty will have an option to…

ByRidhi RastogiJanuary 12, 2026

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Johnson & Johnson Reports Topline P-IIb (JASMINE) Trial Data on Imaavy (Nipocalimab) for Systemic Lupus Erythematosus (SLE)

Shots: J&J has reported the topline P-IIb (JASMINE) trial data assessing Imaavy (nipocalimab) vs PBO in 228 adults with SLE, along with the initiation of the P-III program Trial met its 1EP with higher SRI-4 composite response at Wk. 24, plus achieved secondary & exploratory endpoints, incl. those indicating the potential of nipocalimab for steroid sparing;…

ByRidhi RastogiJanuary 7, 2026

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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 RastogiDecember 26, 2025

Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration

ViiV Healthcare Reports P-IIb (EMBRACE) Trial Data on Lotivibart + Cabotegravir for HIV Treatment

Johnson & Johnson Highlights QUASAR LTE Data on Tremfya (Guselkumab) in Ulcerative Colitis at ECCO 2026

Teva and Sanofi Report P-IIb (RELIEVE UCCD) LTE Study Data on Duvakitug in Inflammatory Bowel Disease

Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Pfizer Reports P-IIb (VESPER-3) Trial Results on PF’3944 in Weight Management

PharmaEssentia Reports the US FDA’s sBLA Acceptance of Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia

Teva and Royalty Pharma Enter Funding Agreement to Accelerate TEV-’408 Development in Vitilgo

Johnson & Johnson Reports Topline P-IIb (JASMINE) Trial Data on Imaavy (Nipocalimab) for Systemic Lupus Erythematosus (SLE)

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

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