Merck Reports P-III (CORALreef AddOn) Trial Data on Enlicitide Decanoate in Hypercholesterolemia

Shots: Trial assessed enlicitide (QD, PO) vs non-statin therapies (PO) added to background statins in adults with hypercholesterolemia & ASCVD risk or history, meeting its 1EP with a 64.6% LDL-C reduction at 8wks. & reductions of 56.7% vs bempedoic acid, 36% vs ezetimibe, & 28.1% vs their combination Trial also showed 8wk. reductions in ApoB…

ByRidhi RastogiMarch 31, 2026

NEWS

Teva Advances Biosimilars Portfolio with Ponlimsi (Denosumab) FDA Approval and Dual Omalizumab Filing Acceptance

Shots: The US FDA has approved Ponlimsi, a biosimilar version of Prolia (denosumab), for all indications of the reference product Approval was based on extensive clinical data, incl. analytical & clinical studies, which showed comparable efficacy, safety, & immunogenicity of Ponlimsi to the reference product Additionally, Teva’s biosimilar of Xolair (omalizumab) was accepted for review…

ByRidhi RastogiMarch 31, 2026

NEWS

BMS Reports P-III (SCOUT-HCM) Trial Data on Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: BMS has reported the 28wk. P-III (SCOUT-HCM) trial data assessing Camzyos (mavacamten) vs PBO in 44 pts (12 to <18yrs.) with symptomatic oHCM & NYHA class II-III symptoms, with plans to present 56wk. data in a future conference Trial met its 1EP, showing reductions in Valsalva LVOT gradient at Wk. 28, supported by more pts…

ByRidhi RastogiMarch 31, 2026

NEWS

Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Pulmonary Hypertension Early

Shots: The FDA has granted 510(k) clearance to an AI-enabled PH algorithm, a software-as-a-medical-device designed to detect early signs of PH, cleared for use with standard 12-lead ECGs The PH algorithm detects subtle early PH patterns in standard 12-lead ECGs & integrates with EHR & ECG management systems, plus it operates entirely within the health…

ByRidhi RastogiMarch 30, 2026

NEWS

The CHMP Recommends Immedica’s Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) to Treat 1L ES-SCLC

Shots: The CHMP has recommended Zepzelca + Tecentriq as a 1L therapy for adults with ES-SCLC whose disease remains stable after initial treatment with Tecentriq, carboplatin, & etoposide Opinion was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced risk of progression or death by 46% & death risk by 27% vs Tecentriq…

ByRidhi RastogiMarch 30, 2026

NEWS

Takeda Presents P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis at AAD 2026

Shots: The 2 P-III (Latitude PsO 3001 & PsO 3002) trials assessed zasocitinib in 693 & 1108 adults with mod. to sev. PsO, with plans for NDA submission to FDA & other authorities starting Takeda’s FY’26 PsO 3001 showed 71.4% achieved sPGA 0/1 vs PBO (10.7%) & apremilast (32.1%), with 39.9% reaching sPGA…

ByRidhi RastogiMarch 30, 2026

NEWS

Pharming Reports the CHMP Positive Opinion on Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta (APDS) Syndrome

Shots: The CHMP has recommended Joenja for the treatment of pts (≥12yrs.) with APDS syndrome, with EC decision expected in Q2’26, which, if positive, would be valid across all 30 EEA member states Opinion was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12 years), showing significant improvement in immune dysregulation…

ByRidhi RastogiMarch 30, 2026

NEWS

Otsuka to Acquire Transcend Therapeutics for ~$1.225B

Shots: Otsuka, via its subsidiary Otsuka America, has entered into an agreement to fully acquire Transcend, with an aim to expand its portfolio in psychiatric & neurological indications As per the deal, Otsuka will acquire Transcend for $700M upfront, & ~$525M in sales milestones, representing the total deal value of ~$1.225B; closing is expected in…

ByRidhi RastogiMarch 30, 2026

NEWS

Insilico Medicine and Eli Lilly Sign ~$2.75B Multi-Program AI-Driven Drug Discovery Collaboration

Shots: Insilico has entered into a drug discovery collaboration with Eli Lilly to accelerate the discovery & development of novel therapeutics across multiple therapeutic areas using Insilico’s Pharma.AI As per the deal, Lilly will gain exclusive global rights to develop, manufacture & commercialize Insilico’s preclinical oral candidates for select indications. Also, both will collaborate on…

ByRidhi RastogiMarch 30, 2026

NEWS

GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B

Shots: The EMA has accepted MAA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB) MAA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml across 29 countries Both trials met…

ByRidhi RastogiMarch 27, 2026

Ridhi Rastogi

Merck Reports P-III (CORALreef AddOn) Trial Data on Enlicitide Decanoate in Hypercholesterolemia

Teva Advances Biosimilars Portfolio with Ponlimsi (Denosumab) FDA Approval and Dual Omalizumab Filing Acceptance

BMS Reports P-III (SCOUT-HCM) Trial Data on Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Pulmonary Hypertension Early

The CHMP Recommends Immedica’s Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) to Treat 1L ES-SCLC

Takeda Presents P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis at AAD 2026

Pharming Reports the CHMP Positive Opinion on Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta (APDS) Syndrome

Otsuka to Acquire Transcend Therapeutics for ~$1.225B

Insilico Medicine and Eli Lilly Sign ~$2.75B Multi-Program AI-Driven Drug Discovery Collaboration

GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B

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