FDA gives thumbs-up to Balversa

The U.S. FDA has granted approval of Balversa (erdafitinib) to Belgium-based Janssen Pharmaceutica, for the treatment of advanced or metastatic bladder cancer. This drug is the first ever approved target-specific medication targeting susceptible FGFR genetic mutations, and for cancer that has progressed during or following prior platinum-containing chemotherapy. FDA granted Balversa the Accelerated Approval to make drugs available for serious conditions and to fulfil unmet needs.

Gilead and Novo Nordisk to target NASH together

Gilead Sciences and Novo Nordisk A/S have announced to join hands to fight Non-Alcoholic Steatohepatitis (NASH). The collaboration to combine clinical trials of Novo Nordisk’s semaglutide (GLP-1 analogue) and Gilead’s cilofexor (FXR agonist) and firsocostat (ACC inhibitor) to treat patients suffering from NASH and advance the understanding of the disease.

A new drug for Hepatitis B/D raises expectations

Myr Pharma-a German pharmaceutical company has reported positive results in phase 2b trial of Bulevirtide to treat chronic hepatitis B and D. Also known as Myrcludex B, it is a novel drug candidate for the treatment of chronic hepatitis B and chronic hepatitis D, and various other inflammatory and metabolic diseases. The trials show the combination of bulevirtide and peginterferon-alfa can be a promising treatment for HBV/HDV coinfection.

Good news for people who want to lose weight

In a recent move, the U.S. FDA has approved a novel prescription drug Plenity, for people who want to get rid of their overweight. Developed by Gelesis- a Boston-based biotechnology company, Plenity is a pill- based medical device, for people with body mass index ranging from 25 to 40, which makes people feel full faster thus reducing their appetite.