TherapeuticsMD bags FDA approval for hormone therapy

The FDA has nodded hormone therapy of TherapeuticsMD for hot flashes that are associated with menopause. Bijuva is an oral treatment that contains molecularly identical (bio-identical) versions of the hormones estradiol and progesterone for menopausal women with a uterus experiencing moderate-to-severe vasomotor symptoms. It was approved with a warning written on it for cardiovascular disorders, probable dementia as well as breast and endometrial cancer. The drug will be made available next year.

Pfizer and Novartis collaborate to aim NASH

Pfizer declared plans to challenge the un­treated fatty liver dis­ease with No­var­tis. A build-up of excess fat in the liver is the characterization of NASH that in­duces chronic in­flam­ma­tion and even­tu­ally leads to scar­ring, which lead to cir­rho­sis, liver fail­ure, can­cer and death. The dis­ease is as­so­ci­ated with obe­sity and di­a­betes that will obscure he­pati­tis C as the lead­ing rea­son for liver trans­plants by 2020. It is difficult to di­ag­nose in the early stages, because of which es­ti­mating its preva­lence is hard, however, stud­ies indicate that it af­flicts up to 12% of the adult pop­u­la­tion in de­vel­oped coun­tries. There are no ap­proved drugs for the dis­ease yet.

The cholesterol drug of Esperion passes the last safety impediment

Esperion, American- based pharmaceutical company, is all set to make the last step in marketing application at the FDA. However, the recent batch of positive safety and efficacy data will not banish the questions on its sales strategy. The drug arm had a moderate drop in LDL of 18% with a 19% cut in high-sensitivity C-reactive protein. In Esperion studies, the therapy fits precisely between the generics that rule the market and the PCSK9s that have had difficulty finding traction, spurring some deep discounting that could spell trouble for Esperion.

Roche extends its PhIII program for Eylea rival as long-acting data back its blockbuster contender faricimab

The Genentech of Roche has secured success to challenge Regeneron and the Big Pharma contender, Novartis. The Researchers told that their bispecific Ang-2/VEGF drug faricimab came up with an improved profile over the player, Lucentis as a long-acting drug for wet AMD. And they scored on long-acting 16-week data, while Regeneron and Novartis have been duking it out over the 12-week niche. Eylea has been the leader of this market, giving Regeneron the profitable franchise market it needs to establish the company’s pipeline and new product offerings. Novartis has been making a mark with brolucizumab (RTH258).