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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, 2025
Circa Scientific
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
Gedeon Richter
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
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
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