Orion Pharma Collaborates with Criceto for Aporon to Treat OFF Episodes in Parkinson’s Disease

Shots: Orion & Criceto have entered into an exclusive license agreement to develop & commercialize Aporon for the treatment of OFF episodes in pts with Parkinson’s disease As per the deal, Orion will obtain global exclusive license of Aporon excl. the US & Canada in exchange for upfront payments, reimbursements for development costs & sales-based…

ByRidhi RastogiApril 25, 2025

NEWS

CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access

Shots: The US FDA has granted 510(k) clearance to PeriCross for controlled & efficient access to pericardial space through subxiphoid approach; US launch expected in coming mos., with select global expansion planned for 2026 Preliminary EASY-R trial data (enrolment completed) in 21 pts showed 100% access success, with mean access time of 3.5 ± 2.2min,…

ByRidhi RastogiApril 25, 2025

NEWS

Johnson & Johnson’s Tremfya Receives the EC’s Approval for Active Ulcerative Colitis (UC)

Shots: The EC has approved Tremfya to treat mod. to sev. active UC adults with inadequate response, no response or intolerance to SoCs or biologics; CHMP recommendation under EC review for mod. to sev. active Crohn’s disease with decision anticipated later 2025 Approval was based on P-IIb/III (QUASAR) trial assessing Tremfya (IV induction: 200mg Q4W;…

ByRidhi RastogiApril 25, 2025

NEWS

VivaVision Biotech Reports Topline P-II Trial Data of VVN461 for Non-Infectious Anterior Uveitis

Shots: VivaVision has reported topline P-II trial data assessing 1.0% or 0.5% VVN461 (JAK1/TYK2 inhibitor) vs 1% prednisolone acetate (PA) for the treatment of non-infectious anterior uveitis in 86 Chinese pts for 28 days Trial demonstrated non-inferior efficacy to PA, achieving a 2-step ACC grade reduction (measured via SUN scale) as the 1EP & significant improvements…

ByRidhi RastogiApril 25, 2025

NEWS

AbbVie Reports the US FDA’s BLA Submission for TrenibotulinumtoxinE (TrenibotE) to Treat Glabellar Lines

Shots: The US FDA has received BLA for TrenibotE (botulinum neurotoxin serotype E) for the treatment of mod. to sev. glabellar lines BLA was supported by 2 pivotal P-III (M21-500 & M21-508) trials & an open-label P-III (M21-509) safety study assessing TrenibotE in over 2,100 pts Trials met their 1 & 2EPs, with onset of…

ByRidhi RastogiApril 25, 2025

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LIFE SCIENCES | DAILY NEWS | APRIL 24, 2025 | PHARMASHOTS

ByRidhi RastogiApril 24, 2025

NEWS

Roche’s Chest Pain Triage Algorithm Secures European CE Mark to Detect Acute Coronary Syndrome (ACS)

Shots: Roche has received the CE mark for its new Chest Pain Triage algorithm, developed with Universitätsklinikum Heidelberg as part of the navify algorithm suite to detect ACS in pts with chest pains; available in the EU, Middle East & Asia, with US availability planned for a later date Algorithm identifies non-cardiac chest pain by…

ByRidhi RastogiApril 24, 2025

NEWS

Repertoire Immune Medicines Collaborates with Genentech to Develop T cell-Targeted Therapies for an Autoimmune Disease

Shots: Repertoire & Genentech have entered into a collaboration & license agreement to identify & develop novel T cell-targeted therapies for an autoimmune disease, leveraging Repertoire’s DECODE platform As per the deal, Genentech will handle preclinical & clinical development along with global marketing in exchange for $35M upfront & ~$730M in development, regulatory & commercial…

ByRidhi RastogiApril 24, 2025

NEWS

Aclaris Therapeutics Reports the US FDA’s IND Clearance of ATI-052 for Immuno-Inflammatory Diseases

Shots: The US FDA has granted IND clearance to ATI-052 for the initiation of P-Ia/Ib trial The P-Ia/Ib trial assessing single & multiple ascending doses of ATI-052 followed by PoC portion in an undisclosed indication, is expected to begin in Q2’25 ATI-052 blocks upstream TSLP receptor signaling & downstream IL-4/IL-13 activation to inhibit a central…

ByRidhi RastogiApril 24, 2025

NEWS

Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)

Shots: Ipsen has reported P-II (ELMWOOD) trial data assessing elafibranor (80 or 120mg) vs PBO in 68 PSC pts for 12wks.; 96wks. OLE study evaluating elafibranor (120mg) is ongoing Trial demonstrated favorable safety & tolerability (1EP) at Wk. 12, with elafibranor 80 or 120mg vs PBO showing TRAEs 68.2%, 78.3% vs 69.6% pts, respectively Elafibranor…

ByRidhi RastogiApril 24, 2025

Ridhi Rastogi

Orion Pharma Collaborates with Criceto for Aporon to Treat OFF Episodes in Parkinson’s Disease

CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access

Johnson & Johnson’s Tremfya Receives the EC’s Approval for Active Ulcerative Colitis (UC)

VivaVision Biotech Reports Topline P-II Trial Data of VVN461 for Non-Infectious Anterior Uveitis

AbbVie Reports the US FDA’s BLA Submission for TrenibotulinumtoxinE (TrenibotE) to Treat Glabellar Lines

LIFE SCIENCES | DAILY NEWS | APRIL 24, 2025 | PHARMASHOTS

Roche’s Chest Pain Triage Algorithm Secures European CE Mark to Detect Acute Coronary Syndrome (ACS)

Repertoire Immune Medicines Collaborates with Genentech to Develop T cell-Targeted Therapies for an Autoimmune Disease

Aclaris Therapeutics Reports the US FDA’s IND Clearance of ATI-052 for Immuno-Inflammatory Diseases

Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)

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