Regulation

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.

USFDA approves EUA for bamlanivimab-etesevimab combo to treat Covid-19 patients

The U.S. Food and Drug Administration (FDA) has approved Emergency Use Authorization (EUA) for investigational bamlanivimab and etesevimab as a combination therapy for the treatment of mild to moderate Covid-19 patients.

USFDA approves Libtayo for skin cancer treatment

The US Food and Drug Administration (FDA) has approved Libtayo to be used for the treatment of patients having two of the most common skin cancers in the US.

USFDA awards Breakthrough Therapy designation to Novartis’ asciminib

Novartis has announced that the novel investigational treatment asciminib, specifically targeting the ABL myristoyl pocket (STAMP), has been awarded Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA).

USFDA approves Breyanzi, new CAR T Cell therapy for adults

Global biopharmaceutical company Bristol Myers Squibb (BMS) has received  US Food and Drug Administration (USFDA) approval for its new CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel).