BMS Receives the CHMP’s Positive Opinion for Abecma (idecabtagene vicleucel) to Treat Multiple Myeloma

Shots: The CHMP positive opinion was based on the results from the P-III (KarMMa-3) clinical trial evaluating Abecma vs standard regimens in patients with r/r multiple myeloma following 2-4 prior lines of therapy. The 1EP of the study was PFS & 2EPs were ORR & OS Following a median follow-up of 30.9mos., the study showed…

ByDipanshu DixitJanuary 26, 2024

NEWS

Evive’s Ryzeneuta (efembalenograstim alfa) Receives the CHMP’s Positive Opinion for the Treatment of Neutropenia and Febrile Neutropenia

Shots: The CHMP has granted a positive opinion to Ryzeneuta (20mg, IV) based on its safety and efficacy evaluation results as compared to PBO The recommendation was made by CHMP for EC’s approval as medicinal product for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with…

ByDipanshu DixitJanuary 26, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2023

Shots: The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis PharmaShots has compiled a list of a…

BySaurabh ChaubeyJanuary 23, 2024

NEWS

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

Shots: The approval was supported by the P-III (MycarinG) study evaluating the safety, efficacy & tolerability of Rystiggo (7 or 10mg/kg) vs PBO in gMG patients. The 1EP of the study includes a change in MG-ADL score at Day43 & 2EPs include a change in MG-C score, QMG, patient-reported outcomes at Day43 and AEs The…

ByDipanshu DixitJanuary 8, 2024

NEWS

BMS Reports EMA’s Validation of Augtyro (repotrectinib) for the Treatment of Solid Tumors

Shots: The EMA has validated MAA of Augtyro for treating adults and pediatric patients (12yrs. & older) with ROS1+ and NTRK+ locally advanced or metastatic solid tumors incl. NSCLC The application was based on two P-I/II (TRIDENT-1 & CARE) trials assessing the safety, tolerability, PK and anti-tumor activity in adults with ROS1+ NSCLC or NTRK+…

ByDipanshu DixitJanuary 2, 2024

INSIGHTS+

New Drug Designations – November 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…

BySenior EditorDecember 27, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in October 2023

Shots: The EMA approved 2 BLA while 7 new chemical Entity, 6 BLA received positive CHMP opinion in October 2023, leading to treatments for patients and advances in the healthcare industry In October 2023, the major highlight drugs were Keytruda + trastuzumab 1L treatment of LA unresectable or metastatic HER2+ gastric or GEJ adenocarcinoma &…

BySenior EditorNovember 23, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in September 2023

Shots: The EMA approved 11 New Chemical Entity (NCE) and 8 Biologic Drugs in September 2023, leading to treatments for patients and advances in the healthcare industry In September 2023, the major highlight drugs were Litfulo (ritlecitinib) for adolescents and adults with s9ere alopecia areata & Orserdu (elacestrant) for ER+, HER2- locally advanced or metastatic…

BySenior EditorOctober 26, 2023

INSIGHTS+

Top Performing Drug – Ocrevus (July Edition)

Shots: In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, we bring for our readers a concise yet thorough analysis of the drug Ocrevus Ocrevus is a prescription medicine used to treat adults with relapsing or primary progressive multiple sclerosis including CIS, RRMS, and SPMS PharmaShots presents…

BySenior EditorJuly 26, 2023

VIEWPOINTS

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on Positive P-III Data for BIIB800 (Actemra biosimilar)

Shots : Dr. Mourad talked about the positive P-III data showing results for BIIB800, a Tocilizumab biosimilar candidate presented at the Annual European Congress of Rheumatology (EULAR 2022) He also spoke about the results of the 48-week analysis of the PROPER trial evaluating adalimumab biosimilar, Imraldi, in patients with autoimmune diseases The interview highlights Biogen's…

BySenior EditorJune 27, 2023

BMS Receives the CHMP’s Positive Opinion for Abecma (idecabtagene vicleucel) to Treat Multiple Myeloma

Evive’s Ryzeneuta (efembalenograstim alfa) Receives the CHMP’s Positive Opinion for the Treatment of Neutropenia and Febrile Neutropenia

Insights+: EMA Marketing Authorization of New Drugs in December 2023

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

BMS Reports EMA’s Validation of Augtyro (repotrectinib) for the Treatment of Solid Tumors

New Drug Designations – November 2023

Insights+: EMA Marketing Authorization of New Drugs in October 2023

Insights+: EMA Marketing Authorization of New Drugs in September 2023

Top Performing Drug – Ocrevus (July Edition)

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on Positive P-III Data for BIIB800 (Actemra biosimilar)

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