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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, 2025

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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, 2025

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Gedeon Richter
NEWS

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

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Akesobio
NEWS

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

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Insights+: The US FDA New Drug Approvals in August 2023
INSIGHTS+

The US FDA New Drug Approvals in March 2025

Shots:      PharmaShots has compiled a list of US FDA-approved drugs in the month of March 2025       The US FDA has approved a total of 2 new drug including 2 new molecular entities leading to the treatment of patients and advances in the healthcare industry        The major highlighted drug was GSK’s Blujepa securing approval for treating…
April 15, 2025

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Key Biosimilars Events of March 2025
INSIGHTS+

Key Biosimilars Events of March 2025

Shots:        Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency         Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients         Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 & BAT2506…
April 8, 2025

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Novartis
NEWS

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Vanrafia for proteinuria reduction in adults with primary IgAN at risk of rapid disease progression based on the ongoing P-III (ALIGN) trial, with no requirement for REMS program; traditional approval will be supported by eGFR results expected in 2026 Trial assessed atrasentan (0.75mg, PO, QD) +…
April 3, 2025

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