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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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NEWS

Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 

  Shots:  The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025  The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from…
September 18, 2024

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Accord Healthcare
NEWS

Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 

Shots:  The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025  The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from the…
September 18, 2024

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Roche
NEWS

Roche Reports the US FDA’s Approval of Ocrevus Zunovo for Treating Relapse and Progressive Multiple Sclerosis 

Shots:     The US FDA has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq), a twice-a-year, 10-minute SC injection, to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)  The approval was supported by the pivotal P-III (OCARINA) study assessing the PK, safety, clinical & radiological efficacy of the Ocrevus SC vs IV in patients (n=236)…
September 13, 2024

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