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CuraTeQ
News

CuraTeQ Biologics Receives CHMP’s Positive Opinion for Dazublys (Biosimilar, Herceptin) 

Shots:  CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EMA’s CHMP has granted a positive opinion to Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, to treat HER2-positive metastatic and early breast cancers. Pending expected EC approval in July, it will be available across the EU member states  The opinion…
April 26, 20250Comments

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Amgen
News

The CHMP Adopts Positive Opinion on Amgen’s Tepezza to Treat Thyroid Eye Disease 

Shots:  The EMA has recommended marketing authorization for Tepezza (teprotumumab) for adults with mod. to sev. thyroid eye disease   The opinion was based on three randomized, PBO-controlled studies in 225 active and 62 chronic TED pts. After 24 wks., Tepezza significantly reduced eye protrusion (−2 to −2.3 mm) in protrusion of the eyeball from the…
April 25, 20250Comments

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Purpose Pharma
News

Purpose Pharma’s Attrogy Receives the CHMP’s Positive Opinion for the Treatment of Hereditary Transthyretin-mediated Amyloidosis  

Shots:  The CHMP has recommended Attrogy (diflunisal) to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult pts. with stage 1 or stage 2 polyneuropathy  The EC will make decision within 67 days, and if approved, Attrogy will be authorized in all EU & EEA countries Iceland, Lichtenstein and Norway  Diflunisal has received EU ODD for…
April 25, 20250Comments

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Orion & Criceto
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, 20250Comments

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Circa Scientific
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,…
April 25, 20250Comments

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J&J
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;…
April 25, 20250Comments

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Vivavision Biotech
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…
April 25, 20250Comments

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PTC Therapeutics
News

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, 20250Comments

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