Regulation

EMA validates Pfizer and OPKO’s somatrogon marketing application for review

The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Pfizer and OPKO’s somatrogon, for review.

ViiV Healthcare seeks USFDA approval to expand Cabenuva use for HIV-1 infected adults

Specialist HIV company ViiV Healthcare has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to expand the use of Cabenuva.

USFDA accepts priority review for Pfizer’s TicoVac

Pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for priority review for TicoVac, a tick-borne encephalitis (TBE) vaccine.

AstraZeneca withdraws Imfinzi indication in US for bladder cancer

AstraZeneca has voluntarily withdrawn the Imfinzi (durvalumab) indication for adult patients who received treatment earlier in the US for locally advanced or metastatic bladder cancer.

Dynavax secures EC marketing authorisation for hepatitis B vaccine

Biopharmaceutical company Dynavax Technologies (DVAX) has secured marketing authorisation from the European Commission (EC) for Heplisav B, a two-dose adult hepatitis B adjuvanted vaccine.

USFDA grants FTD to efanesoctocog alfa for hemophilia A treatment

The U.S. Food and Drug Administration (FDA) has granted efanesoctocog alfa – earlier termed BIVV001 (rFVIIIFc-VWF-XTEN) – Fast Track Designation (FTD) for the treatment of patients suffering from hemophilia A.

Novartis secures expanded FDA indication label for Entresto

Swiss pharmaceutical company Novartis has secured the expanded US Food and Drug Administration (FDA) indication for Entresto, a Novartis therapy to treat patients diagnosed with guideline-defined heart failure.

Celltrion Healthcare secures EC authorisation to sell Yuflyma

South Korean biopharmaceutical company Celltrion Healthcare has secured European Commission (EC) marketing authorisation for the sale of Yuflyma (CT-P17) for the treatment of multiple chronic inflammatory diseases.

Sandoz to acquire GlaxoSmithKline’s cephalosporin antibiotics business

Global leader in antibiotics and a division of Swiss multinational pharma company Novartis, Germany-based Sandoz has signed a contract to acquire GlaxoSmithKline’s (GSK) cephalosporin antibiotics.