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IntraBio
NEWS

IntraBio’s Aqneursa Receives the US FDA’s Approval for Treating Niemann-Pick Disease Type C 

Shots:     The US FDA has granted approval to Aqneursa (levacetylleucine) for treating adults & pediatric patients (≥15kg) with neurological manifestations of Niemann-Pick disease type C (NPC)  Approval was supported by pivotal P-III (IB1001-301) study assessing the effect of Aqneursa vs PBO on neurological symptoms & functioning in pediatric (≥4yrs.) & adults (n=60) with confirmed NPC …
September 25, 2024

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Insights+: EMA Marketing Authorization of New Drugs in August 2024
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in August 2024

Shots:    The EC has approved to 5 Biologics and 3 New Chemical Entities in August 2024, leading to treatments for patients and advances in the healthcare industry   The major highlighted drugs were Johnson & Johnson’s Balversa to treat Metastatic Urothelial Carcinoma (mUC) and Takeda’s Adzynma for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)  PharmaShots has compiled a list…
September 24, 2024

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Henlius and Intas
NEWS

Henlius and Intas’ Hetronifly (Serplulimab) Receives the CHMP’s Positive Opinion to Treat Extensive-Stage SCLC 

     Shots:    The positive opinion of Hetronifly (anti-PD-1 mAb) was supported by ASTRUM-005 study assessing it with CT vs PBO as a 1L treatment of ES-SCLC patients (n=585) in various regions. It is approved in China under the brand name Hansizhuang for the same  Henlius partnered with Intas in 2023 to develop & commercialize…
September 21, 2024

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Pfizer
NEWS

Pfizer Reports the CHMP’s Positive Opinion of Hympavzi (Marstacimab) to Treat Hemophilia A and B 

      Shots:    The CHMP has recommended Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively   The opinion was based on data of 116 subjects (12-75yrs.) from a pivotal P-III (BASIS) study treated with marstacimab (300mg loading dose followed by…
September 20, 2024

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NEWS

AbbVie Reports the CHMP’s Positive Opinion of Elahere (Mirvetuximab Soravtansine) to Treat Ovarian Cancer 

      Shots:    The CHMP has granted positive opinion to Elahere for treating FRα+, Pt-resistant & high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer in adults who have received 1 to 3 prior therapies. The decision is anticipated in Q4’24, with other reviews underway  The opinion was based on P-III (MIRASOL) study assessing Elahere…
September 20, 2024

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Zevra Therapeutics
NEWS

Zevra Therapeutics Receives the US FDA’s Approval of Miplyffa (Arimoclomol Citrate) for Treating Niemann-Pick Disease Type C (NPC) 

Shots:     The US FDA has awarded priority review voucher & approved Miplyffa (47mg to 124mg, oral, TID) + miglustat to treat neurological manifestations in adults & pediatrics (≥2yrs.) with NPC, with its launch planned within 8-12wks.    Approval was based on trial of Miplyffa + miglustat vs PBO in NPC patients (2-19yrs.), showing halted disease progression…
September 20, 2024

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Disease of the Month – Systemic Lupus Erythematosus
INSIGHTS+

Disease of the Month – Systemic Lupus Erythematosus

Shots:  Systemic lupus erythematosus (SLE) is an autoimmune disorder where the body's immune system targets and damages healthy tissues  In this reprise of our Disease of the Month report, we present an enlightening description of SLE with a thorough study of epidemiology, market size, disease management, potential medicines, patient advocacy groups, and the key players involved    For a…
September 18, 2024

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NEWS

Organon and Shanghai Henlius Biotech Provides Update on P-III Trial of HLX11 (Biosimilar, Perjeta)

  Shots:  The P-III study assessing safety & efficacy of HLX11 vs Perjeta (pertuzumab) in addition to trastuzumab & docetaxel (Q3W, 4 cycles) as a neoadjuvant regimen for treating patients, randomized 1:1, with HER2+/HR- locally advanced breast cancer has reached the 1EP  The 1EP of the trial includes total pathological complete response (tpCR) rate as…
September 18, 2024

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