PharmaShots

APRIL 7, 2023

TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis Date: Apr 3, 2023 | Tags: TG Therapeutics, Briumvi, Ublituximab-xiiy, Multiple Sclerosis, Regulatory, EMA, CHMP BMS Receives EMA’s CHMP Positive Opinion of Breyanzi (lisocabtagene maraleucel) for (..)

Biosimilars 53

Biosimilars Immunity Immunization 53

PharmaShots

APRIL 21, 2023

Oblato Reports the First Patient Enrolment of OKN-007 in the P-I Clinical Trial for Recurrent High-Grade Glioma Date: Apr 21, 2023 | Tags: Oblato, OKN-007, Recurrent High-Grade Glioma, Regulatory, Henry Ford Health System CARsgen's CT041 Receives the US FDA’s IND Clearance for the Postoperative Adjuvant Therapy of Pancreatic Cancer Date: (..)

Labelling 40

Labelling 40

pharmaphorum

OCTOBER 29, 2021

Merck is the obvious partner for that ambition as Keytruda is in the ascendency among checkpoint inhibitors for TNBC, having also recently also picked up an FDA approval pre-surgery alongside chemotherapy in the neoadjuvant setting, as well as in the post-surgery (adjuvant) setting as a monotherapy, to prevent tumours from recurring.

Chemotherapy 52

Chemotherapy 52

PharmaShots

MARCH 10, 2023

Vertex Receives the US FDA’s IND Clearance of VX-264 for the Treatment of Type 1 Diabetes Date: Mar 10, 2023 | Tags: Vertex, VX-264, Type 1 Diabetes, Regulatory, US, FDA, IND Alnylam Expands its Collaboration with Medison Pharma to Commercialize RNAi Therapies Date: Mar 10, 2023 | Tags: Alnylam, Medison Pharma, RNAi Therapies, Onpattro, patisiran, (..)

Diabetes 40

Diabetes Biosimilars Vaccines 40

GMPSOP

FEBRUARY 25, 2023

Sampling requirement for Critical and Non-Critical Excipients Critical excipient are raw materials that are defined as those directly added to final product formulation, whose function is as an adjuvant, preservative or an antioxidant. Apply Red Dot in Compression/Encapsulation area in place of “Sampled By” tag or label.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

RX Note

FEBRUARY 9, 2024

Adjuvant therapy 辅助治疗- Extra therapy given after a primary treatment. Skin tags 皮赘 - Small, soft, skin-coloured growths on your skin. Acute 急性 - Signifies a condition that begins abruptly and is sometimes severe, but the duration is short. Adverse drug reaction 药物不良反应 - Unintended, harmful events attributed to the use of medicines.

Immunity 40

Immunity Immunization Diabetes Communication 40