European Pharmaceutical Review

JANUARY 16, 2024

Compared with standard intravenous (IV) delivery, Roche stated that its monoclonal antibody biologic shortens treatment time by approximately 80 percent. This is according to findings from a Phase III study of atezolizumab comparing subcutaneous versus intravenous administration.

Hospitals 97

Hospitals 97

Hospital Pharmacy Europe

JANUARY 18, 2024

It is the first PD-(L)1 cancer immunotherapy for subcutaneous (SC) injection available in the European Union and offers the potential for a faster and more convenient alternative to intravenous (IV) infusion of atezolizumab. This is 75% quicker than the 30-60 minute duration of the IV infusion.

Hospitals 101

Hospitals 101

European Pharmaceutical Review

FEBRUARY 2, 2024

Biogen is planning to reprioritise its resources allocated to ADUHELM ® (aducanumab-avwa), to advance its Alzheimer’s treatment LEQEMBI ® (lecanemab-irmb) and to develop new treatment modalities. The Phase IV post-marketing confirmatory ENVISION study was required to obtain US FDA accelerated approval of ADUHELM.

FDA 82

FDA 82

European Pharmaceutical Review

AUGUST 29, 2023

This is compared to 30-60 minutes via intravenous (IV) administration. Clinical data for Tecentriq SC Approval of the monoclonal antibody is based on clinical data from the Phase IB/III IMscin001 study. The safety and efficacy profile was consistent with the IV formulation.

Immunization 90

Immunization FDA 90

European Pharmaceutical Review

AUGUST 1, 2022

Therefore, it is essential that we broaden the scope of medical trials and research,” commented Tinamarie Duff, DAWN Global People & Business Resource Group Lead. Common clinical trial practices exclude up to a quarter of the US population based on disability status, according to BMS.

Pharmaceutical Companies 115

Pharmaceutical Companies Pharmaceutical Companies FDA 115

The Thyroid Pharmacist

APRIL 28, 2023

3] In those with sarcopenia, reduced enzyme activity was observed on mitochondrial complexes I, II and III, while those with myopathy had reduced activity on complex IV, indicating that there are differences in the way these types of muscle conditions affect us on a cellular level. This mechanism is known as “pregnenolone steal.”

Immunization 94

Immunization Dosage Compounding Communication 94

PharmaShots

MARCH 1, 2023

The early phase of part 1 includes a safety run-in period with 3-6 patients to receive HLX15 (IV), monitored for safety for 1wk. The 1EP is the area under the serum drug concentration-time curve from time 0 to infinity & 2EPs incl. other PK parameters, safety & immunogenicity. vs 6.2); in switched patients (1.0 vs 1.3) @24wks.

FDA 40

FDA Packaging Labelling 40