NEWS

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…

April 25, 2025

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,…

April 25, 2025

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;…

April 25, 2025

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…

April 25, 2025

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…

April 25, 2025

Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva)

Shots: The CHMP has recommended marketing authorization for Junod and Yaxwer, biosimilars of Amgen’s Xgeva & Prolia (denosumab) Denosumab is approved to treat postmenopausal osteoporosis, prevent bone complications from cancer metastases, and treat unresectable giant cell tumors of bone Junod & Yaxwer are mAbs (IgG2) that block RANKL, preventing osteoclast activation Ref: Gedeon Richter | Image: Gedeon Richter…

April 25, 2025

PTC Therapeutics’ Sephience Receives the CHMP’s Positive Opinion for the Treatment of Phenylketonuria (PKU)

Shots: The CHMP has issued a positive opinion recommending marketing authorization for Sephience (sepiapterin) to treat PKU in patients of all ages and disease severities, expected the EC approval within two mos., with the decision applying across the EU including Iceland, Norway, and Liechtenstein Sepiapterin's NDA is under FDA review (PDUFA: July 29, 2025), and…

April 25, 2025

Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

Shots: The US FDA has approved penpulimab-kcqx + CT (cisplatin/carboplatin + gemcitabine) as 1L treatment for recurrent or metastatic non-keratinizing NPC in adults, & as monotx. for those with metastatic non-keratinizing NPC progressing on/after Pt-based CT & ≥1L prior therapy Approval was supported by 2 BLA submissions based on international P-III (AK105-304) trial & pivotal…

April 25, 2025

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…

April 24, 2025

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…

April 24, 2025

NEWS

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

Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva)

PTC Therapeutics’ Sephience Receives the CHMP’s Positive Opinion for the Treatment of Phenylketonuria (PKU)

Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

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

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