Teva and mAbxience Join Forces on Second Biosimilar Candidate in Oncology

Shots: Teva and mAbxience have entered into a second global licensing agreement to develop an anti PD-1 biosimilar candidate in oncology As per the agreement, mAbxience will employ its state-of-the-art, cGMP-compliant facilities in Spain and Argentina for the development & production of biosimilar while Teva will handle its regulatory approvals & commercialization The agreement…

ByDipanshu DixitOctober 3, 2024

NEWS

Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara)

Shots: The US FDA has approved Otulfi (SC & IV), biosimilar of Stelara (ustekinumab), to treat Crohn’s disease, ulcerative colitis, mod. to sev. plaque PsO & active psoriatic arthritis. Fresenius Kabi can market Otulfi by Feb 22, 2025 Approval was based on analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity…

ByDipanshu DixitSeptember 30, 2024

NEWS

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

Shots: The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…

ByDipanshu DixitSeptember 27, 2024

NEWS

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

Shots: The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…

ByDipanshu DixitSeptember 27, 2024

NEWS

GE HealthCare Reports the US FDA’s Approval of Flyrcado (Flurpiridaz F 18) PET Radiotracer for Improved CAD Diagnosis

Shots: The US FDA has approved Flyrcado injection as a PET MPI agent to diagnose CAD, with its launch planned in early 2025 The effectiveness of Flyrcado was assessed under the P-III (AURORA) study in comparison with both invasive coronary angiography as a standard and SPECT MPI to identify CAD In addition, GE HealthCare secured…

ByDipanshu DixitSeptember 27, 2024

NEWS

BMS’ Cobenfy (Xanomeline and Trospium Chloride) Receives the US FDA Approval for Treating Schizophrenia

Shots: The US FDA has granted approval to BMS’ Cobenfy for treating schizophrenia in adults, based on its EMERGENT studies The EMERGENT studies comprised of P-III (EMERGENT-2 & 3) trials, evaluating the safety, efficacy & tolerability of Cobenfy vs PBO in schizophrenic adults for over 5wks., as well as two open-label trials assessing long-term safety…

ByDipanshu DixitSeptember 26, 2024

NEWS

Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio)

Shots: Alvotech has begun the confirmatory trial of AVT16, biosimilar version of Entyvio (vedolizumab), that targets alpha-4-beta-7 protein for treating Ulcerative Colitis and Crohn’s disease The P-III (AVT16-GL-C01) trial is a double-blind, two-arm study comparing the efficacy, safety & immunogenicity of AVT16 vs Entyvio in patients of age 18-80yrs. with moderate to severe active…

ByDipanshu DixitSeptember 25, 2024

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 …

ByDipanshu DixitSeptember 25, 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…

ByDipanshu DixitSeptember 24, 2024

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…

ByDipanshu DixitSeptember 21, 2024

Dipanshu Dixit

Teva and mAbxience Join Forces on Second Biosimilar Candidate in Oncology

Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara)

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

GE HealthCare Reports the US FDA’s Approval of Flyrcado (Flurpiridaz F 18) PET Radiotracer for Improved CAD Diagnosis

BMS’ Cobenfy (Xanomeline and Trospium Chloride) Receives the US FDA Approval for Treating Schizophrenia

Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio)

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

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

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

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