Europe – Page 38 – pharmaceutical daily

July 16, 2021 Off

FDA Advisory Committee: roxadustat does not support approvals in anaemia of chronic kidney disease

The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has reached almost unanimous vote that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in chronic kidney disease (CKD) in non-dialysis dependent (NDD) adult patients, and that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in CKD in dialysis-dependent (DD) adult patients.

July 16, 2021 Off

Immupharma adds COO to the board of directors

By Dino Mustafić

ImmuPharma, the specialist drug discovery and development company, has appointed Dr Tim Franklin, Chief Operating Officer, to the Board of Directors.

June 24, 2021 Off

Adtralza approved as the first and only treatment specifically targeting IL-13 only for adults with moderate-to-severe atopic dermatitis

By Dino Mustafić

LEO Pharma UK said that the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) has approved tralokinumab for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

June 22, 2021 Off

Mean IgG levels in people treated with Kesimpta remained unchanged over 3.5 years

By Dino Mustafić

On Tuesday, Novartis disclosed new data showing mean IgG and IgM levels remain unchanged in adults with relapsing multiple sclerosis (RMS) treated with Kesimpta® (ofatumumab) over 3.5 years.

April 22, 2021 Off

BMS builds new cell therapy manufacturing facility in the Netherlands

By Author

Bristol Myers Squibb has selected Leiden, Netherlands to house a new cell therapy manufacturing site in Europe, leveraging the growing…

April 14, 2021 Off

AstraZeneca’s non-small cell lung cancer approved in China

By Author

AstraZeneca’s Tagrisso has been approved in China for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor…

April 14, 2021 Off

Sodium-bicarbonate can help reduce Covid symptoms, study shows

By Dino Mustafić

A certain peer-reviewed study (see more here) carried out at the Welcare Hospital, India, found out that kitchen staple, bicarbonate of soda is found to significantly reduce Covid-19 symptoms.

April 13, 2021 Off

Boehringer Ingelheim and Zealand Pharma Advance to Phase 2 Clinical Testing in NASH and Obesity

By GlobeNewswire

Company announcement – No. 21/ 2021 Boehringer Ingelheim and Zealand Pharma Advance to Phase 2 Clinical Testing in NASH and…

March 31, 2021 Off

Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna

By Author

EMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines…

March 31, 2021 Off

GSK to support manufacture of Novavax’ COVID-19 vaccine

By Author

GSK has reached an agreement in principle with Novavax and the UK Government Vaccines Taskforce to support manufacturing of up…