Eli Lilly Reports P-II (ALPACA) Trial Data of Lepodisiran for Heart Diseases

Shots: The P-II (ALPACA) trial assessed lepodisiran (16, 96, or 400mg) vs PBO for ~18mos. in 320 pts, who were dosed at baseline & day 180, with an additional arm receiving 400mg at baseline & PBO at day 180; P-III [ACCLAIM-Lp(a)] trial enrollment is ongoing Trial met its 1EP, with 400mg reducing Lp(a) by 93.9%…

ByRidhi RastogiMarch 31, 2025

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BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

Shots: The CHMP has recommended Opdivo + Pt-based CT as neoadj. followed by Opdivo alone as adj. treatment of adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1%. If approved, EC’s decision would be valid in all 30 EEA states The P-III (CheckMate-77T) study assessed neoadj. Opdivo + CT, followed by surgery…

ByRidhi RastogiMarch 31, 2025

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Shanghai Henlius Biotech and Organon Reports EMA’s Validation of HLX11 (Biosimilar, Perjeta)

Shots: The EMA has validated MAA of HLX11, a biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Submission was supported by P-III trial evaluating HLX11 vs Perjeta as neoadj. therapy in HER2+/HR-, early stage or locally advanced breast cancer as part of complete treatment regimen. Study met its 1EP of total…

ByRidhi RastogiMarch 28, 2025

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Crinetics Pharmaceuticals Reports the EMA’s Acceptance of Paltusotine for Acromegaly

Shots: Following ODD grant, the EMA has accepted MAA of paltusotine for the treatment & long-term maintenance of acromegaly; NDA under the US FDA's review (PDUFA: Sep 25, 2025) Submission was supported by data from 18 trials, incl. 2 P-III trials (PATHFNDR-2 & PATHFNDR-1) assessing paltusotine vs PBO in treatment-naïve & experienced pts, respectively. These…

ByRidhi RastogiMarch 28, 2025

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Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…

ByRidhi RastogiMarch 28, 2025

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Abbott Secures European CE Mark for Volt PFA System to Treat Atrial Fibrillation

Shots: Abbott has received European CE Mark for its Volt PFA System to treat pts with atrial fibrillation; commercialization has begun, with further expansion in EU markets expected by H2’25 Approval was based on CE Mark study in the EU & Australia, showing that the Volt achieved pulmonary vein isolation (PVI) in 99.1% veins with…

ByRidhi RastogiMarch 28, 2025

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BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

Shots: Japan’s MHLW has approved Beyonttra to treat ATTR-CM in adult pts based on P-III (ATTRibute-CM) study assessing Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts; commercialization to begin in H1’25 Trial showed 42% decrease in composite ACM & recurrent CVH events, plus 50% reduction in cumulative frequency of CVH events at 30mos., with pts…

ByRidhi RastogiMarch 28, 2025

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Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

Shots: The P-III (3475A-D77) trial assessed SC Keytruda (Q6W) + berahyaluronidase alfa + CT vs IV Keytruda (Q6W) + CT in 1L metastatic NSCLC adults (n=377), regardless of PD-L1 TPS expression; BLA under the US FDA’s review (PDUFA: Sep 23, 2025) & MAA under EMA’s review Trial showed that SC is noninferior to IV in AUC…

ByRidhi RastogiMarch 28, 2025

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Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides

Shots: Ionis has granted Sobi global exclusive rights of olezarsen excl. the US, Canada & China to treat familial chylomicronemia syndrome (FCS) & severely elevated triglycerides; Ionis to independently market Olezarsen in the US, whereas Theratechnologies holds the rights in Canada As per the deal, Ionis will get an upfront, with potential milestone payments &…

ByRidhi RastogiMarch 27, 2025

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Bayer Enters Global License Agreement with Suzhou Puhe BioPharma for its PRMT5 Inhibitor

Shots: Bayer & Suzhou Puhe BioPharma have entered into a global license agreement for Puhe BioPharma’s PRMT5 inhibitor to treat MTAP-deleted tumors As per the deal, Bayer will obtain rights to develop, manufacture & commercialize MTA-cooperative PRMT5 inhibitor globally; financial terms remain undisclosed Bayer to develop the asset under development name BAY 3713372, with first…

ByRidhi RastogiMarch 27, 2025

Ridhi Rastogi

Eli Lilly Reports P-II (ALPACA) Trial Data of Lepodisiran for Heart Diseases

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

Shanghai Henlius Biotech and Organon Reports EMA’s Validation of HLX11 (Biosimilar, Perjeta)

Crinetics Pharmaceuticals Reports the EMA’s Acceptance of Paltusotine for Acromegaly

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Abbott Secures European CE Mark for Volt PFA System to Treat Atrial Fibrillation

BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides

Bayer Enters Global License Agreement with Suzhou Puhe BioPharma for its PRMT5 Inhibitor

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