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 productApproval was based on extensive clinical data, incl. analytical & clinical studies, which showed comparable efficacy, safety, & immunogenicity of Ponlimsi to the reference productAdditionally, 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 conferenceTrial met its 1EP, showing reductions in Valsalva LVOT gradient at Wk. 28, supported by more pts…

ByRidhi RastogiMarch 31, 2026

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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 ECGsThe 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

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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, & etoposideOpinion 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

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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

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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 statesOpinion 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 indicationsAs 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.AIAs 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

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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 countriesBoth trials met…

ByRidhi RastogiMarch 27, 2026

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Novartis to Acquire Excellergy for ~$2B

Shots:Novartis has entered into an agreement to acquire Excellergy, incl. its asset Exl-111, strengthening Novartis immunology strategy in food allergy & other IgE-driven diseases As per the deal, Novartis will acquire Excellergy for ~$2B, incl. upfront & milestone payments, with closing expected in H2’26EXL-111 is engineered to dissociate receptor-bound IgE, enabling faster &…

ByRidhi RastogiMarch 27, 2026

Ridhi Rastogi

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

Novartis to Acquire Excellergy for ~$2B

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